All Positions

Jobs - Julie Bukar - Founder - JGB BioPharma Consulting Inc

Our job site is updated frequently. New jobs appear on the top of the Complete Job Openings Listing. However, please feel free to send your resume or an email inquiry to Jobs@JGBBioPharma.com. Then we can contact you if a good job fit arises.

< Back to Jobs home

1) Admininistrative / Professional – HR – Contract (New Jersey) 3758

2) CMC Regulatory Manager / Sr. Manager / Associate Director – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AW113F

3) Project Coordinator – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) BW82F

4) Clinical Pharmacologist – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A133GB

5) CRA I /II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) S117JT

6) EHS Specialist – Contract (New York) 73V0049

7) Clinical Supply Chain - Trial Supply Operations – Contract (Pennsylvania) 8954

8) Associate Scientist I - R&D – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) 73P7323

9) Marketing – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) 8595R73

10) Scientist I – Contract (Massachusetts) 7653

11) Global Market & eBusiness Liaison – Contract (Southern California) 5014G73

12) Administrative Assistant – Contract (Massachusetts) 3635

13) Shipping Coordinator – Contract (Pennsylvania) 8024

14) Executive Director, Project Management – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R82BT

15) Coordinator – Contract (New Jersey) 9838

16) Director Clinical Operations – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) TG125P

17) (Senior) Associate Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) MA132W

18) Sr Manager , Scientific & Technical Publishing – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132GL

19) Warehouse Operator – Contract (Pennsylvania) 7931

20) Biotech Recruiter / Sourcing Specialist – Full Time or Part Time (San Francisco Bay Area)

21) Production Tech – Contract (Massachusetts) 73H0288

22) Data Trade Analyst – Contract (New Jersey) 6161

23) Lab Tech – Contract (Texas) 5920V73

24) Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) P111AY

25) Metrology – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) XR111A

26) Senior Product Data Steward – Contract (Oregon) 73G5297

27) Project Manager – Contract (New Jersey) 2410

28) SAP Financial Systems Analyst – Contract (New Jersey) 9126

29) Buyer – Contract (New Jersey) 0504

30) Senior Administrative Assistant – Contract (Maryland) 7081P73

31) Senior Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) P111BL

32) Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) TM111Z

33) Director CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) XF132H

34) Manager / Sr. Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B132WN

35) Director / Sr. Director, Regulatory Affairs – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G129FS

36) Associate Director / Sr. Manager Clinical Supply Chain – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JQ111V

37) Project Coordinator – Contract (New Jersey) 9044

38) Senior Clinical Biometrics Analyst – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R109AX

39) Sr. Administrative Assistant – Contract (Southern California) 73P0412

40) Clinical Trial Manager – Contract (New Jersey) 9049

41) Manager, Clinical Supply Chain – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132BN

42) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 1144F73

43) Senior Clinical Data Manager – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G129RX

44) Admininistrative/Professional – HR – Contract (New Jersey) 9919

45) CBT Developer / LMS Administrator – Contract (Southern California) 73R4156

46) Accountant – Contract (Southern California) 1790T73

47) Technical Writer – Contract (Pennsylvania) 4062

48) QA Technical Writer – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) PG127A

49) QA Expert (Principal Quality Representative) – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) F127JN

50) Associate Manager / Manager, Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa) OT127Z

51) Clinical Research Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B127HY

52) Account Receivable Clerk – Contract (New York) 73M3017

53) Associate Director QC Team Lead – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A131AF

54) Training Coordinator – Contract (New Jersey) 0718

55) Patent Attorney, Director – Full Time (New York) XA130J

56) Clinical Program Manager – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B94RP

57) Scientist – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) SP111K

58) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) FL129B

59) Senior Java Software Engineer – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) RF103P

60) QC Technician – Contract (New York) 4618R73

61) Administrative Assistant III – Contract (New Jersey) 6991

62) Biostatistician – Contract (Massachusetts) 6455

63) Supply Chain Manager – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) T82BL

64) Clinical / Scientific – Contract (San Francisco Bay Area) 73B4746

65) Packaging Engineer – Contract (Pennsylvania) 9838

66) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) F128KZ

67) Regulatory Manager External Pharmaceutical Production – Contract (New Jersey) 9959

68) Regulatory Manager External Pharmaceutical Production – Contract (New Jersey) 9959

69) Publications Manager – Contract (New Jersey) 6735

70) Engineering – Contract (San Francisco Bay Area) 4103B73

71) Specialist, Quality Assurance – 6-12 Month Contract (San Francisco Bay Area) G94LT

72) Clinical Project Manager – Full Time Position (San Francisco Bay Area) Z104GN

73) Bioinformatics Quality Scientist - Medical Genetics – Full Time Position (San Francisco Bay Area) B103MJ

74) Manager/Sr. Manager, Clinical Contracts and Outsourcing – Full Time Position (San Francisco Bay Area) RY111J

75) Project Coordinator – Contract (New Jersey) 8376

76) Procurement / Contracts Specialist – Contract (New Jersey) 8287

77) Manager/Senior Manager, Clinical Contracts – Full Time Position (San Francisco Bay Area) C111KP

78) Director/Senior Director Clinical Development & Medical Monitor – Full Time Position (San Francisco Bay Area) W82BR

79) Research Associate – Contract (~ 25 hr/wk for 6 mths or longer; San Francisco Bay Area) B999RT

80) Director / Sr Director Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) Y111AE

81) Software Engineer – Contract (Oregon) 2076A73

82) Senior Medical Director, Drug Safety – Full Time Position (San Francisco Bay Area) MT114A

83) Drug Safety Scientist – Contract or Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) E114AX

84) Associate Director/Director, Epidemiology – Full Time Position (San Francisco Bay Area) AR114F

85) Systems Engineering Manager – Full Time Position (New York) B126XG

86) Medical Director – Full Time Position (San Francisco Bay Area) R125FW

87) Sr. Product Manager – Full Time Position (San Francisco Bay Area) P73AG

88) Principle Investigator – Contract (Pennsylvania) 8095

89) Head of Project Management – Full Time Position (San Francisco Bay Area) R121MT

90) Associate Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) RT111D

91) Manager, Drug Safety Science – Full Time Position (San Francisco Bay Area) F114JX

92) Manager / Senior Manager, Drug Safety – Full Time Position (San Francisco Bay Area) H114FZ

93) Director, Drug Safety & Pharmacovigilance – Full Time Position (San Francisco Bay Area) GB114A

94) Medical Director – Full Time Position (San Francisco Bay Area) B114TN

95) Professional Discovery Research – Contract (Massachusetts) 8555

96) SCRA to Clinical Trial Manager – Contract or Full Time (San Francisco Bay Area) R82BW

97) Sr Director / Director Clinical Operations – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R117GX

98) Sr. QA Associate/QA Manager – Full Time Position (San Francisco Bay Area) G104XB

99) Senior SCRA to Clinical Program Manager Level – Full Time Position (San Francisco Bay Area) W111HL

100) Sr. Manager Training – Full Time Position (San Francisco Bay Area) T114GR

101) Manager, Quality Assurance – Full Time Position (San Francisco Bay Area) D114QF

102) Software Quality Engineer – Full Time (Midwest) RG73B

103) Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) F114NB

104) Statistical Programmer III – Full Time Position (San Francisco Bay Area) B114NG

105) Principal Statistical Analyst/ Senior Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) G114RF

106) Senior Biostatistician – Full Time Position (San Francisco Bay Area) B114MT

107) Clinical Supplies Project Manager – Full Time Position (San Francisco Bay Area) FM110Y

108) Clinical Supplies Project Manager – Full Time Position (San Francisco Bay Area) FM110Y

109) Clinical Supplies Project Manager – Full Time Position (San Francisco Bay Area) FM110Y

110) (Sr) Research Associate, Analytical – Contract (San Francisco Bay Area) B120GT

111) (Sr) Research Associate, Analytical – Contract (San Francisco Bay Area) B120GT

112) Corporate Paralegal – Full Time Position (San Francisco Bay Area) T111KX

113) Clinical Contracts Administrator / Paralegal – Full Time Position (San Francisco Bay Area) GY111P

114) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

115) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

116) Director, Statistical Programming – Full Time Position (San Francisco Bay Area) X111JP

117) IVD Systems & Verification Engineer – Full Time Position (San Francisco Bay Area) B118HZ

118) Recruiter – Contract (Pennsylvania) 7757

119) Document Control Specialist – Contract (San Francisco Bay Area) 2039N73

120) Senior QA Specialist, Manager – Contract to Full Time (San Francisco Bay Area) BK106P

121) Process Engineer Expert – Full Time Position (San Francisco Bay Area) QG116P

122) Sr. Database Developer (Software Engineering III) – Two Full Time Positions (Midwest) G73RP

123) Clinical Trial Manager – Contract (San Francisco Bay Area) JX111Q

124) Senior Director, Healthcare Compliance – Full Time Position (San Francisco Bay Area) BR114F

125) Regulatory Analyst – Full Time Position (Maryland) BX73F

126) Senior Project Manager – Full Time Position (San Francisco Bay Area) B114TG

127) Clinical Trial Manager / Sr Clinical Trial Manager – Full Time Position (San Francisco Bay Area) RF117Q

128) Clinical Project Manager – Full Time Position - 1-2 days/wk in-house (San Francisco Bay Area) ZG104M

129) Senior Regulatory Affairs Specialist – Full Time Position (San Francisco Bay Area) RY115M

130) Administrative / Professional - HR – Contract (New Jersey) 9919

131) Senior Statistical Programmer – Full Time Position (San Francisco Bay Area) ZA111H

132) Engineer III QA \ QC – Full Time Position (Wisconsin) B73NG

133) (Sr) Manager Regulatory – Full Time Position (San Francisco Bay Area) KS132P

134) Coordinator, Materials Process Management – Full Time Position (San Francisco Bay Area) WG96H

135) Associate Director, Regulatory Affairs – Full Time Position (San Francisco Bay Area) B96RL

136) Project Manager, Medical Affairs – Full Time Position (San Francisco Bay Area) HB109Y

137) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

138) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

139) Consulting Ontologist – Contract (San Francisco Bay Area) FR103P

140) Lead CRA (in-house) – Full Time Position (San Francisco Bay Area) ZW104M

141) Scientist – Contract (Maryland) 73X8089

142) Commercial Compliance Manager/ Sr Manager – Full Time Position (San Francisco Bay Area) PX100J

143) Clinical Scientist – Full Time Position (San Francisco Bay Area) TM111X

144) Document Control Specialist – Contract - 6 Months (San Francisco Bay Area) T96RB

145) Senior Manager, Bioinformatics – Full Time Position (Midwest) B73FN

146) Senior Manager/Associate Director, Regulatory Affairs – Full Time Position (San Francisco Bay Area) XM96F

147) Statistician – Contract (New Jersey) 8014

148) Clinical Trial Manager – Full Time Position (San Francisco Bay Area) T96NH

149) Senior Clinical Research Associate / Clinical Trial Manager – Full Time Position (San Francisco Bay Area) MJ96F

150) Regulatory Consultant – Contract (San Francisco Bay Area) P108DR

151) Sr. Staff Scientist, Translational Medicine – Full Time (Midwest) M73QL

152) Staff Scientist, Bioinformatics – Full Time (Midwest) W73BH

153) Scientist III, Bioinformatics – Full Time Position (Midwest) P73NA

154) CMC Regulatory Associate Director / Director – Full Time Position (San Francisco Bay Area) SM80Y

155) Senior Manager / Associate Director, Regulatory Affairs – Full Time Position (San Francisco Bay Area) XV80J

156) Senior / Principal Medical Writer – Full Time Position (San Francisco Bay Area) T80BR

157) Associate Director, Clinical Data Management – Full Time Position (San Francisco Bay Area) XT96G

158) Senior Data Manager – Full Time Position (San Francisco Bay Area) GL85B

159) IT Technical Writer – 6 month contract (San Jose Area) N96GB

160) Sr. Medical Writer – Full Time Position (San Francisco Bay Area) JN85P

161) ERP Finance / IT Analyst – Contract or Full Time Position (San Francisco Bay Area) GN96Q

162) Sr. Product Manager, Software Solutions – Full Time Position (San Francisco Bay Area) B73XS

163) Sr. Product Manager, Software – Full Time Position (San Francisco Bay Area) B73XS

164) Bio-Statistician with SAS Programming Skills – Contract (New Jersey) 4624

165) Senior Data Manager – Consultant (San Francisco Bay Area) G108PN

166) Clinical Recruiter – Contract or Full Time Position (San Francisco Bay Area) NG104B

167) Diagnostics Product Line Business Owner – Full Time Position (San Francisco Bay Area) RC103X

168) Regional Clinical Research Associate – Full Time Position (Texas) N104BX

169) Senior Software/Scientific Quality Engineer – Full Time Position (San Francisco Bay Area) MZ103R

170) Senior Software/Scientific Quality Engineer – Full Time Position (San Francisco Bay Area) MZ103R

171) Manager, Medical Information – Full Time Position (San Francisco Bay Area) GT96B

172) Clinical Database Programmer – Full Time Position (New York / New Jersey) M100PT

173) Associate Scientist I - R&D – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) 73X9093

174) Accountant II – Contract (New Jersey) 4972

175) Project Manager (up to Director Level) – Full Time Position (San Francisco Bay Area) G96FD

176) Project Manager (up to Associate Director Level) – Full Time Position (San Francisco Bay Area) G96FD

177) Manager/ Assoc Director CMC Regulatory – Full Time Position (San Francisco Bay Area) NB96X

178) Project Manager – Full Time Position (San Francisco Bay Area) RH73B

179) (Senior) Clinical Trial Manager – Full Time (San Francisco Bay Area) R96TW

180) Human Resources Assistant – Full Time (San Francisco Bay area)

181) Internal Auditor III (Finance) – Full Time Position (San Francisco Bay Area) H95TJ

182) CRAII / Senior Clinical Research Associate II (SCRA) – Contract or Full Time Position (San Francisco Bay Area) B80CR

183) Clinical Program Manager – Full Time Position (San Francisco Bay Area) R80BS

184) Technical Recruiter / Sourcing Specialist – (Full Time or Part-time, Contract or FTE; United States)

185) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

186) Licensed PM Shift Clinical Laboratory Scientist (CLS) Supervisor – Full Time Position (San Francisco Bay Area) J75SP

187) CMC Regulatory Director/ Sr. Director – Full time Position (San Francisco Bay Area) L62EJ

188) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

189) Senior/Associate Director Program Manager – Full Time or Contract (San Francisco Bay Area) P73BY

190) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

191) Senior/Associate Director Program Manager – Full Time or Contract (San Francisco Bay Area) P73BY

192) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

193) Licensed PM Shift Clinical Laboratory Scientist (CLS) Supervisor – Full Time Position (San Francisco Bay Area) J75SP

194) Clinical Laboratory Scientists I (CLS I) Day and PM Shift Licensed Clinical Laboratory – Full Time Position (San Francisco Bay Area) T75PS

195) Licensed Clinical Laboratory Scientist (CLS) Supervisor – Full Time Position (San Francisco Bay Area) MR75L

196) Clinical Laboratory Scientists I (CLS I) Day and PM Shift Licensed Clinical Laboratory – Full Time Position (San Francisco Bay Area) T75PS

197) Paralegal/Contracts Associate – Part Time Position 20 Hrs/week (San Francisco Bay Area) YR90W

198) Manager, Sr. Manager, Regulatory Affairs CMC – Contract or Full Time Position (San Francisco Bay Area) Q77AB

199) (Senior) Reliability Engineer Manufacturing & Production/ Industrial Manufacturing – Full Time Position (San Francisco Bay Area) S62BA

200) Equipment Maintenance Technician – Contract (Massachusetts) 73U0626

201) Licensed Clinical Laboratory Scientist (CLS) Supervisor – Full Time Position (San Francisco Bay Area) MR75L

202) Senior Statistical Analyst/ Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) JM96B

203) Associate Director/ Principal, Biostatistics – Full Time Position (San Francisco Bay Area) F96MP



1) Admininistrative / Professional – HR – Contract (New Jersey) 3758

DESCRIPTION:

  • Review payroll timekeeping input to ensure timely completion and accuracy; compare timekeeping systems with employee pay to ensure compliance with proper processes.  
  • Partner with retained payroll team and payroll vendor to resolve issues and identify areas of process improvements.

EXPERIENCE AND QUALIFICATIONS:

  • Strong attention to detail
  • Familiarity with hourly timekeeping practices  
  • Ability to interact with all levels of the organization.  
  • Multitasking capabilities and ability to organize large quantities of information.
  • College degree preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

2) CMC Regulatory Manager / Sr. Manager / Associate Director – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AW113F

DESCRIPTION:

Responsible for managing the CMC aspects of domestic and international regulatory affairs for commercial and clinical projects.  The candidate will be responsible for researching and interpreting global CMC regulations and guidances, and providing early guidance to Quality and Manufacturing team members.  The candidate will also work closely with CMC teams, corporate partners, and contract manufacturing organizations to prepare complete and accurate regulatory submissions, and meet established timelines.  Expertise with biologics is essential.

  • Responsible for proactively managing CMC aspects of one or more global commercial programs. 
  • Plan, manage, and oversee preparation and submission of global CMC submissions, including marketing and clinical trial applications. 
  • Provide responses to regulatory authority questions regarding product information or issues.
  • Ensure that CMC content is complete, well-written, and meets all relevant requirements. 
  • Represent the RA CMC function on assigned cross-functional project teams.
  • Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and provide strategic regulatory guidance for optimal implementation of changes. 
  • Manage interactions with FDA or other regulatory authorities for assigned project.  
  • Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.

EXPERIENCE AND QUALIFICATIONS:


  • Experience in filing marketing applications, supplements, variations for biologic products in the US is required; global submission experience desired.
  • Experience in assessing post-marketing changes
  • Thorough understanding of relevant drug development regulations and guidelines.
  • Outstanding interpersonal and communication (written and verbal) skills.
  • Strong writing and editing skills for technical documentation.
  • Proficient with computer and standard software programs.
  • Previous supervisory experience a plus.
  • At least 4-6 years of experience in Regulatory Affairs in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of the product lifecycle). 
  • Expertise with biologics is essential.
  • BA/BS degree in life sciences minimum. 
  • Advanced degree a plus.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

3) Project Coordinator – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) BW82F

DESCRIPTION:

  • Basic meeting planning and coordination: scheduling meetings, preparing agenda’s with input from project manager or subject matter experts, facilitating meetings and writing draft minutes. 
  • Providing supervised project management support
  • Developing timelines for key projects
  • Developing and implementing processes
  • Assisting project managers with complex program deliverables (i.e. preparing for a management meeting, conducting risk assessment exercise, etc)

EXPERIENCE AND QUALIFICATIONS:

  • Highly proficient with MS Office: Word, Excel, PowerPoint, Outlook & MS Project 
  • Familiarity with Webex (or other similar systems) & Visio. 
  • Excellent interpersonal, organization, verbal and written communication skills 
  • Problem-solving skills 
  • Attention to detail 
  • Ability to organize and prioritize tasks in a timely and accurate manner 
  • Ability to meet tight deadlines 
  • Ability to work collaboratively in a dynamic environment 
  • Minimum 3 years prior Biotech/Pharmaceutical experience or other relevant work experience 
  • PMP (desirable /not required) 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

4) Clinical Pharmacologist – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A133GB

DESCRIPTION:

  • Reporting to the SVP, Clinical Research and Development, the Medical Director will be responsible principally for early clinical drug development activities with a strong focus on Phase I and Phase IIa clinical trials.  
  • Will work closely with members of the R&D team to ensure a strategic view is taken for the pipeline progression of individual projects. 
  • In collaboration with others in Clinical Research and Development, design and execute clinical studies (ADME, special populations, pharmacokinetic, and pharmacodynamic) to support existing and new compounds in development.
  • Responsible for the medical oversight and conduct of clinical pharmacology studies
  • Identify, evaluate, and interact with clinical study sites including assessment of strengths and weakness of medical functions  
  • Responsible to contribute to, review, and finalize clinical study reports of clinical pharmacology studies
  • Interact with regulatory authorities as required in support of ongoing development programs 
  • Medical monitor in sponsored studies as appropriate, ensure that the clinical teams correctly handle all adverse events (AEs) and serious adverse events (SAEs) in accordance with ICH standards 
  • Correctly apply the ICH and GCP regulations surrounding the primary activities of clinical development projects 
  • Operate within the time and budget constraints of the clinical program 
  • Communicate project-related information, including responsibility for planning and preparation for meetings and presentations 
  • Coordinate and complete scientific documents including protocols, clinical study reports, other regulatory documents
  • Collaborate with biometrics, bioanalysis, and clinical operations to achieve study objectives
  • Interact effectively with counterparts at collaboration partners to accomplish company objectives related to strategic partnerships  

EXPERIENCE AND QUALIFICATIONS:

  • Randomized controlled clinical trial principles, methodology and procedures 
  • Adverse medical event investigation, analysis, as well as reporting procedures and standards 
  • Extensive knowledge of clinical pharmacokinetics and modeling principals
  • FDA and EMA regulatory requirements and ICH/GCP guidelines is an asset 
  • Federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects 
  • Statistical data collection, editing, validation and analysis techniques 
  • Current and developing trends and standards in clinical trials monitoring 
  • Industrial standards as applied to GCP and GLP 
  • Infrastructure and operational characteristics of Contract Research Organizations (CROs) and centralized clinical laboratories 
  • Ability to develop and implement clinical research protocols and study specific procedures 
  • Ability to communicate, interact and present competently and professionally both verbally and in writing at all levels within a broad, complex clinical research environment including third parties such as partners, CRO’s, and academia 
  • Travel up to 30% as necessary according to project needs
  • Registered Medical Doctor (mandatory qualification) 
  • Board certification/specialist registration in clinical pharmacology highly desirable or significant prior relevant experience
  • 7-10 years of experience in drug development in the pharmaceutical and/or biotech industry, covering both early and translational phase development or significant participation in industry sponsored research as a clinical investigator
  • PhD in clinical pharmacology would be an asset 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

5) CRA I /II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) S117JT

DESCRIPTION:

  • Responsible for implementing and monitoring clinical trials and expands experience in clinical trial and vendor management procedures.  
  • Works closely with study coordinators and investigators to ensure compliance with protocol and overall clinical objectives. 
  • Identifies projects/tasks and works with Clinical Trial Manager to complete.  
  • Demonstrates ability to carry out all CRA I functions with minimal supervision.  
  • In collaboration with manager and/or Lead CRA, maintains consistent CRF data quality and discrepancy interpretation across sites.   
  • May conducts site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
  • Develops study tools and guidelines to be utilized by study sites
  • Assists in the process used to evaluate and select potential investigators and sites
  • Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues and assigned sites
  • Understands study timelines and manages sites to meet timelines
  • Collaborates with team to maintain consistent CRF data quality and discrepancy resolution across sites
  • Performs manual, in-house review of CRF data in clinical database for completeness and accuracy
  • Reviews site’s informed consents against the consent template for presence of all GCP requirements and protocol specific information. 
  • Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy; Ensures study records are auditable both at investigational sites and in-house
  • Responsible for initiating and tracking quarterly site payments

EXPERIENCE AND QUALIFICATIONS:

  • Verbal and written communication skills are required.  
  • Attention to detail and organizational skills
  • Working knowledge of GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • 2+ years of CRA experience in an industry setting, or four years of pharmaceutical/health care field experience including 1 year previous experience as a CRA.
  • Experience in clinical research at a pharmaceutical/biotech company; 
  • BS/BA degree in a life science, RN, or related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

6) EHS Specialist – Contract (New York) 73V0049

DESCRIPTION:

  • Conduct site safety inspections
  • Conduct JHA's
  • Conduct safety training
  • Update EH&S metrics and enter data into the EHS database
  • Evaluate and update written safety programs
  • Input data in various EH&S management systems

EXPERIENCE AND QUALIFICATIONS:

  • Strong communication
  • Strong computer skills
  • Excellent organizational skills
  • College degree in a science related field  

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

7) Clinical Supply Chain - Trial Supply Operations – Contract (Pennsylvania) 8954

DESCRIPTION:

  • Receive product demand from clinical and insure that product demand is met with a balanced cost/time solution to allow an on time start of the clinical trial.  
  • Assures the timely supply of product by interacting with a variety of suppliers/manufacturers.  
  • Work closely with the CSC Project Leader in developing the supply and distribution master strategies by providing GXP documentation expertise for the drafting and review of Label Specification form (LSF), Technical Agreement and Services Quotation (TASQ), Individual Project Agreement (IPA) in support of clinical trials, and other activities as they relate to the support and evolution of the CSC. 
  • Will interface with relevant functional areas both domestically and internationally to assure clinical trial documents are aligned with the clinical trial demand, and are available for approval and use in alignment with the master supply strategy as well as relevant production schedules.  
  • Work closely with a CSC Project Leader to align prioritization of activities to insure the CSC goal of clinical trials starting on time is met.    
  • Additional duties would include provide coordination of activities associated with the distribution, returns, and reconciliation of clinical trial material in support of an assigned clinical trial.  
  • Procurement of vaccine doses, movement of vaccine doses to the labeling and/or distribution depots, close interaction with Clinical to assure adequate vaccine inventory, and final reconciliation at conclusion of the clinical trial.

EXPERIENCE AND QUALIFICATIONS:

  • Thorough understanding of GXP regulations with respect to vaccine label/packaging, distribution, returns, and reconciliation as well as experience with supply chain procedures and clinical trial operations is required. 
  • Excellent ability to interface with a variety of functional areas within the clinical supply chain.  
  • Excellent oral and written communication skills to include presentations in support of training on new procedures. 
  • High attention to detail. 
  • Excellent negotiation skills. 
  • Strong problem solving skills. 
  • Excellent ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization; effective time management skills. 
  • Exercises calm, sound constructive judgment during high demanding situations. 
  • Ability to organize and lead meetings.
  • Experience with MS Office Suite (Excel, Word, PowerPoint), flow diagramming and project management software required.  
  • Strong understanding and past experience documentation databases (eDoc), Trackwise, and SAP
  • Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree) or related discipline and at least 5 to 9 years’ experience in pharmaceutical business experience required, preferably within supply chain and manufacturing environments. Must be well versed in at least 2 of the three aspects of the clinical supply chain process: GMP, GCP, GDP and as well as other regulatory requirements as they pertain to investigational products.  
  • Project management and APICS certifications desired.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

8) Associate Scientist I - R&D – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) 73P7323

DESCRIPTION:

  • Carry out Oligonucleotide synthesis, purification and analysis in the production of oligo requests. 
  • Operating DNA synthesizers and associated equipment
  • Operating HPLC,Mass spec or CE equipment for purification and/or analysis of oligos
  • Safely handles chemical materials and checks for calibration of lab equipment
  • Maintains production records following Good Documentation Practices.
  • Adheres to ISO13485 guidelines
  • Plan the use of equipment, materials and own time. 
  • Assist in lab procurement, calibration or maintenance. 
  • Make detailed observations and basic data analysis. 
  • Advise supervisor of factors that may affect quality, accuracy, timeliness and usefulness of data. 
  • Comply with all company safety regulations and procedures.

EXPERIENCE AND QUALIFICATIONS:

  • Laboratory skills is a plus. 
  • Ability to work independently and is a great communicator. 
  • Computer familiarity required.
  • Bachelor's degree in Biology, Chemistry, Biochemistry or other related discipline or the equivalent knowledge and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

9) Marketing – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) 8595R73

DESCRIPTION:

  • Duties will include updating product catalog, preparing customer facing slide decks, competitive analyses and product life cycle management.
  • Updating Pharma Analytics catalog
  • Sales tool for sample preparation solutions
  • Refresh product slide decks along with marketing.
  • Competitive analyses (all products): web review, customer interviews based on a list of questions.
  • Conversion of User Guides to online (paperless versions) for all pending product lines
  • Obsolete PNs not in use/ not making revenue for the last several years
  • Web review for products for clean-up and updates.

EXPERIENCE AND QUALIFICATIONS:

  • Prior experience in marketing/product management preferred (1-2 years).
  • Bachelor's Degree

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

10) Scientist I – Contract (Massachusetts) 7653

DESCRIPTION:

  • Contribute to the early stage oncology drug discovery research 
  • Will involve the biological sample preparation and consequential analysis of molecules ranging from small molecule to proteome with advanced mass spectrometers to identify clinically translatable biomarkers and understand cell signaling network and mechanism of actions.
  • Design and implementation of the enrichment protocols, processing of complex biological sample, acquiring/compiling “Omics” data, and maintaining advanced instrumentation. 
  • Will work very closely with a diverse group of drug discovery scientists including bioanalytical chemists, biochemists and biologists.

EXPERIENCE AND QUALIFICATIONS:

  • Experience of mammalian tissue/cell culture, hand-on mass spectrometry experience or proteomics sample preparation will be considered advantageous. 
  • Should demonstrate strong passion for science, the ability to work independently and efficiently, and the ability to think critically and creatively about scientific challenges. 
  • Strong verbal and written communication skills are critical
  • Demonstrated skills on using analytical and purification techniques commonly used in cell biology, such as affinity chromatography, immunoprecipitation, gel electrophoresis, and western blotting would be desirable. 
  • The successful candidate should have a BS on biochemical sciences, such as biochemistry, cell and molecular biology, chemical biology or related area discipline with some knowledge about “omics” approach. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

11) Global Market & eBusiness Liaison – Contract (Southern California) 5014G73

DESCRIPTION:

  • Review and edit written material to ensure accuracy, neatness, correct punctuation and grammar
  • Recommend changes to improve readability and clarity.
  • Coordinate, assist in planning, prepare agendas and monitor meetings
  • May be required to perform other related duties as required and/or assigned.
  • Training and meeting logistics
  • Weekly email and report updates
  • Creation of dashboards
  • Working with vendors
  • Creating/sending promotional flyers
  • Serving as the SAP-LMS training admin

EXPERIENCE AND QUALIFICATIONS:

  • Word processing
  • Desktop publishing (to include presentations, spreadsheets, and graphs-Excel)
  • Manage and coordinate projects and programs to ensure high quality end results within given timeframe.
  • Ability to maintain confidential and specialized files, records and reports
  • Excellent written and oral communication skills required
  • Must be able to interface effectively with all levels of employees
  • Accuracy is required in performing all functions of this position. Initiative and organization skills are required
  • Event/Logistics planning
  • Strong communication skills
  • Must possess self-motivation, enthusiasm, a positive attitude and perform as a team player. 
  • Knowledge of office/secretarial practices normally acquired through college level courses or equivalent work experience is required. 
  • Associates or Bachelors degree preferred but not required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

12) Administrative Assistant – Contract (Massachusetts) 3635

DESCRIPTION:

  • Support the consolidation, preparation and/or design of presentations. 
  • Manage outlook calendars.  
  • Coordinate on and off-site meetings with internal and external stakeholders/customers.  
  • Arrange and provide support for meetings (distribute all pre/post meeting agendas, programs, presentations and all necessary travel logistics).
  • Coordinate travel arrangements including registrations and liaison with the travel department to proxy on behalf of department team members.  
  • Manage expense reports.
  • Performs clerical duties as requested: maintains files according to business standards 
  • Sorts, prioritizes and distributes mail promptly
  • Orders office supplies.
  • Serve as a liaison on confidential and sensitive issues to other senior executives.
  • Performs other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Proficient use of the entire Microsoft Windows applications (e.g. Word, Excel, PowerPoint)
  • Ability to manage multiple, sometimes conflicting priorities in a fast-paced and demanding environment and ensure smooth and efficient flow of day-to-day operations
  • Strong organizational and communication skills
  • 5+ years of experience in administrative support in a pharmaceutical or biotech company preferred
  • Bachelor's Degree

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

13) Shipping Coordinator – Contract (Pennsylvania) 8024

DESCRIPTION:

  • Supporting the computer and paperwork activities required for warehouse and distribution.
  • Representing each stage of the shipment and its tracking information in the appropriate inventory management systems, from the time its leaves the facility through to delivery to the end-user
  • Filing of all paperwork as well as maintaining the controlled GMP filing area
  • Other computer and paperwork activities as assigned 

EXPERIENCE AND QUALIFICATIONS:

  • Basic computer skills
  • Strong organizational skills.  
  • Must have the proven ability to work independently, pick up tasks quickly and multi-task/prioritize workload in a dynamic, timeline driven, high volume, culturally diverse organization
  • HS, prefer Bachelors

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

14) Executive Director, Project Management – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R82BT

DESCRIPTION:

Summary:

The Executive Director of Project Management (EDPM) is a member of the Management Team and provides oversight and overall leadership of Project Management. Serves as the formal interface between Project Teams and the Management Team.  Implement a PMO and guide the management team, project teams and the organization in developing process maturity and organizational integrity with respect to Project Management.  Serve as project manager on development projects as needed and mentor and develop Project Managers to support the company’s portfolio.     

Responsibilities:
  • Lead and/or manage project teams; ensure development/operational plans are consistent with corporate strategic objectives and oversee teams to achieve efficient and effective performance.
  • Serve as a neutral facilitator, communicate openly and timely, horizontally and vertically in order to achieve transparency of project progress and lead to resolution of conflicts in good faith
  • Establish and maintain a Project Management Office to ensure consistent processes and techniques are deployed by Project Teams to deliver projects on time, on budget with appropriate quality
  • Drive and facilitate project review process at management level.  
  • Ensure appropriate team issues are elevated to management in a timely manner.  
  • Chair formal or ad hoc internal management processes regarding project decision points and or/project issue resolution.
  • Work collaboratively with functional heads to ensure appropriate internal and external resources are applied to projects and accurately reflected in the company budget
  • Lead and mentor project managers and ensure training and development are focused towards building competencies to support both current and future needs of the business.

EXPERIENCE AND QUALIFICATIONS:

  • Solid conflict resolution, problem solving and decision making skills required. 
  • Strong familiarity with pharmaceutical drug development and FDA, ICH, cGMP, EU, and other regulatory guidelines.
  • Proven ability to interface in multi-functional teams and influence others to work together collaboratively.  
  • Excellent interpersonal skills to establish cohesive teams and interact effectively at all levels in the organization.
  • Must be able to organize, lead and direct diverse activities in a changing environment.  
  • Excellent communication skills to effectively communicate to both technical and non-technical audiences.  
  • Must be self-motivated who strives to make a significant impact.  
  • Must be creative and flexible when solving problems and able to encourage and engage input from others.
  • Minimum 10 years of experience in Project Management. 
  • Demonstrated accomplishment in leading Project Management.  
  • Proven ability to manage effectively by influence.
  • BS/MS Physical or Life Sciences and at least 15 years industry experience in biopharmaceutical and/or drug development experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

15) Coordinator – Contract (New Jersey) 9838

DESCRIPTION:

  • Responsibilities will include maintaining field sales roster; preparing support materials; preparing/tracking budgets; assisting with sales forecasts; communicating with sales force and corporate office; and facilitating travel/meeting planning.
  • Coordinate with HR and the field leadership team to maintain roster for current field sales organization. 
  • Coordination of communications to the field team, including meetings and written updates.
  • Provides daily proactive administrative support
  • Primarily responsible for maintaining calendars, coordinating meetings and making travel arrangements
  • Organize agendas and ensure minutes/follow up’s for field leadership meetings.
  • Serves as primary point person for team building initiatives.
  • Regularly interfaces with internal management and staff to complete tasks 
  • Professionally interacts with external and internal parties. (contacts are frequent with individuals representing outside organizations, and or individuals of significant importance within the company)
  • Assists with organizing team meetings, including travel planning and accommodations and logistics
  • Assist in generating and formatting basic presentations
  • Manages communications and distribution via SharePoint, email or other media as requested
  • Provides clerical support including online expense reporting, filing, faxing, copying, scanning, shipping.
  • Ensures supply needs are met, including online purchasing consistent with company SOPs
  • Exercises discretion when handling confidential material and information
  • Assists additional team members with administrative duties as needed 

EXPERIENCE AND QUALIFICATIONS:


  • Proactive problem solving ability
  • Good sense of judgment
  • Ability to prioritize effectively
  • Proactively communicates timetables for completion of tasks
  • Ability to navigate organization with minimal direction, in support of completing tasks
  • Excellent organizational, interpersonal, and communication skills.
  • Extensive knowledge of the MicroSoft Office Software such as Microsoft Word, Excel, PowerPoint, and Outlook.
  • Must be detailed oriented and able to handle various tasks.
  • Must be flexible with work schedule and with overtime.
  • Must have advanced knowledge of or ability to quickly learn internal electronic systems to facilitate completion of tasks (NEXTS, Concur, Catalyst.)
  • High School Diploma; some college courses preferred.
  • Minimum 3 years related experience, preferably in pharmaceutical environment.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

16) Director Clinical Operations – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) TG125P

DESCRIPTION:

  • Line management of CT Manager(s),Clinical Trial Associates (CTAs) , and other functional members as needed. One or more direct reports to start.
  • Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues.
  • Performance management: Tasks include and are not limited to: setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports. Identify and address performance issues and training needs.
  • Partner with Medical Director to ensure consistent high quality of work while timelines are met
  • Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables.
  • Lead strategic planning and process development/ implementation for the function(s), tracking timelines to remain on schedule, and developing contingency strategies, if needed.
  • Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials.
  • Lead/participate in meetings to plan and implement cross-functional operational activities to increase quality, productivity, and efficiency within Clinical Operations.
  • Ensure effective and efficient collaboration between internal customers and external providers (CROs). 
  • Liaise with internal (Study Management, site contracting, Central Services) and external (investigational sites and vendors) partners/stakeholders to assess functional team processes/performance and opportunities for development/enhancement.
  • Maintain clear lines of communication with functional managers to ensure high quality deliverables are met.
  • Utilize creative techniques to gain enrollment in rare disease clinical trials.

EXPERIENCE AND QUALIFICATIONS:

  • Phase 1, 2, 3 experience required
  • Line management and experience required
  • Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must.  Leadership skills.
  • Ability to foster a collaborative team environment, motivate others, work in teams in a matrix environment and with various levels both within company and with vendors as appropriate.
  • Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work effectively in a fast paced matrix environment.
  • Demonstrated competency in leading cross-functional process improvement efforts.
  • Demonstrated leadership and management skills, prior supervisory experience with demonstrated success in managing people, and expertise in mentoring and coaching.
  • Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. 
  • Knowledge of medical terminology.
  • Strong computer skills to include MS Office: Word, Excel and PowerPoint. 
  • BA/BS or equivalent degree in life sciences or allied health field.
  • Minimum of 10 years experience in clinical operations roles, including at least 3 years of global clinical trial experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

17) (Senior) Associate Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) MA132W

DESCRIPTION:

  • Responsible for supporting the CMC regulatory strategy and coordinating the process for compiling CMC section of regulatory submissions.
  • Reviews CMC documentation to ensures they meet regulatory requirements.
  • Coordinates CMC regulatory  workflow between departments as well as CROs
  • Coordinates and compiles CMC document packages and investigational drug shipment related activities for drug manufacturing according to regulations/guidelines and company SOPs
  • Assembles, coordinates and compiles  technical documents needed to complete CMC section of regulatory submissions.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
  • Assists in the coordination of drafting of responses to regulatory questions in a timely manner.
  • Assists in the review of change controls and provides regulatory impact assessment as needed. 
  • Escalates issues that affect registration, and regulatory compliance to CMC Regulatory Affairs Management

EXPERIENCE AND QUALIFICATIONS:

  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
  • Proficient with computer (MS Office) and internet skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
  • Proven ability to communicate with executive management, cross-functional team members and operational staff.
  • Flexible attitude with respect to work assignments, and new learning.
  • 1 to 6 years relevant regulatory CMC  experience
  • BS in Chemistry; Advanced degree preferred. (MS, PhD or PharmD or equivalent)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

18) Sr Manager , Scientific & Technical Publishing – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132GL

DESCRIPTION:

Summary:

Responsible for the publication of regulatory documents according to regulatory authority specifications and department standards for paper and electronic submissions. Assists in the development of electronic submissions standards and tools.  The Manager/Sr. Manager, Regulatory Publishing also coordinates the review and revision of all regulatory documents for submission to regulatory agencies.  This position generally receives no instruction on routine work but detailed instruction on new assignments.

Responsibilities:
  • Integrates data from various electronic or paper sources into either electronic or paper submissions using format and style essential for regulatory compliance with established operating procedures, and current medical and technical writing standards. 
  • Must collaborate effectively with contract team members to publish, copy, assemble, quality check, and publish required documents.  
  • In addition, he/she will continue to develop expertise through participation in both internal and external technical training. 
  • Demonstrate proficiency in required software.
  • Provide word processing, advanced formatting, and publishing assistance to Regulatory and Clinical personnel.
  • Create and maintain templates for regulatory submissions.
  • Assist in maintenance of Regulatory archives.
  • Assist with the incorporation of document comments from multiple reviewers including text, graphs, charts, tables and statistical analysis
  • Review documents for format compliance to current style guidelines and correct deficiencies within timeline
  • Assist with the coordination of regulatory document routing, revision tracking, proof-reading, and document approvals
  • May perform additional tasks and duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • Basic understanding of the US, EU, and ICH regulations and guidelines.
  • Demonstrated proficiency in MS Office including advanced use of styles, automated table of contents and cross-references, version control, change tracking, indexes, styles, macros, charts and embedded graphics, forms and toolbars; assist in bookmarking, hyperlinking, and compiling electronic submissions within Adobe Acrobat.
  • Strong technical background including proficiency in document publishing, desktop publishing, scanning, Microsoft Office, Adobe Acrobat, PowerPoint, standard graphics and publishing software, Endnote, MS Project, etc.
  • Follow proofreading marks, use accepted styles and terminology, provide limited copyediting.
  • Ability to work independently with minimal supervision.
  • Strong interpersonal skills.
  • Demonstrated verbal and written communication skills.
  • Ability to multi-task, pay close attention to detail, and follow projects through to completion.
  • Excellent organizational, prioritization, and planning skills.
  • 6-8 years related experience in publication and scanning of assorted documents or images supporting regulatory submissions; requires previous experience in regulatory submissions, license applications, etc., within the pharmaceutical, biotech, or related field.
  • Bachelor’s degree desired or equivalent relevant experience in Regulatory Publishing

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

19) Warehouse Operator – Contract (Pennsylvania) 7931

DESCRIPTION:

  • Support all warehousing activities including receiving of incoming goods, dispensing packaging components to the packaging department
  • Supporting the Annual Physical Inventory
  • Supporting the destruction process and any other Inventory management activities.  
  • Required to provide backup assistance for all shipping activities

EXPERIENCE AND QUALIFICATIONS:

  • Familiarity with GMP compliance is a plus.  
  • Knowledge of Inventory Management software a plus.   
  • Must be detailed oriented, dependable, and able to work independently and also in a team environment.  
  • Looking for a candidate who can pick up tasks quickly and multi-task/prioritize workload in a dynamic, timeline driven, culturally diverse organization.
  • High school diploma or equivalent is required. 
  • Spoken and written English required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

20) Biotech Recruiter / Sourcing Specialist – Full Time or Part Time (San Francisco Bay Area)

DESCRIPTION:

  • We have openings for several recruiters and are therefore flexible in terms of the work arrangement. These positions are remote (work from home office). We are open to anywhere in the USA but prefer candidates in the San Francisco Bay area.
  • Primary responsibilities are to source open positions with qualified candidates
  • Document/track recruiting activities in candidate tracking system.
  • Source, screen and interview candidates to determine fit for open positions
  • May handle specific client accounts and interact with clients if experience warrants this

EXPERIENCE AND QUALIFICATIONS:

  • MUST have minimum of 2 years of solid recruiting experience
  • Experience with Pharma, Biotech, Diagnostics or Medical Device companies is REQUIRED
  • Prior experience and absolute comfort with making cold calls
  • Must be self-motivated, present well and be able to develop relationships with candidates
  • Ability to navigate through change and demonstrate flexibility as organizational needs shift
  • Excellent organizational skills and the ability to work independently is very important
  • Must develop and implement creative sourcing strategies to identify talent in addition to utilizing company sourcing tools
  • Must have established home office situation; Prefer those who have previously worked remotely
  • Bachelor degree is REQUIRED
  • Must live in the United States and have U.S. work status

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

21) Production Tech – Contract (Massachusetts) 73H0288

DESCRIPTION:

  • Carry out standard operating procedures involving materials measurement, materials handling and inventory control, equipment operation and record keeping necessary to manufacture product batches as instructed. 
  • Record keeping includes but is not limited to Batch Data Records, notebooks, customer reports and work order documents. 
  • Maintain accurate inventory of products and inventory records using the Materials Resource Planning tools (i.e. issuing materials to work orders, completing products to inventory, kitting, closing, transfers, returns, expensing of raw materials, WIP and finished product). 
  • Complete production and quality analysis of reagents, components and finished products in accordance with the Production Schedule. 
  • Communicate manufacturing problems to manufacturing management and the team and assist in identifying variables and offering resolutions. 
  • Keep manufacturing supervisors and team members informed on the status of assigned production processes. 
  • May train other team members on techniques and processes. 
  • Complete all batch data records completely, according to quality systems standards as required.
  • May perform other related duties as required and/or assigned. 
  • This position largely interacts with equivalent levels of personnel in the manufacturing area. 
  • The job encounters semi-routine work situations of limited scope and complexity where ability to recognize deviation from accepted practice is required.

EXPERIENCE AND QUALIFICATIONS:

  • Good oral and written communication skills are required to communicate work status and problems. 
  • Effectiveness in this role requires a functional knowledge of applicable manufacturing process and Standard Operating Procedures and the ability to consistently and accurately follow procedures. 
  • Accuracy is required in performing all functions of this position; errors in work could cause delays in schedules. 
  • The incumbent normally receives general instructions on routine work and detailed instruction on new assignments.
  • High school diploma required; technical training in manufacturing preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

22) Data Trade Analyst – Contract (New Jersey) 6161

DESCRIPTION:

  • Manage excel customer lists and provide updates to specialty wholesalers on changes and additions.
  • Develop sales reports from 3rd party tools that summarize current purchases by customer.
  • Review weekly and daily data submissions to ensure no sales to non-eligible customers.  
  • Provide communications to wholesalers and internal teams for issues.
  • Validate wholesaler EDI data submissions for accuracy and compliance with contractual requirements.
  • Support the communications process for price changes to internal and external customers.

EXPERIENCE AND QUALIFICATIONS:

  • Must have strong knowledge and skills in Microsoft Office especially with Excel
  • Strong analytical and communication skills with the ability to summarize results
  • Previous experience working in pharmaceuticals, preferred
  • Knowledgeable about Trade or Contract Operations is a plus
  • Must be able to communicate effectively and work collaboratively with, peers and other business areas.  
  • Must be very detail oriented, and organized. 
  • BA or BS degree preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

23) Lab Tech – Contract (Texas) 5920V73

DESCRIPTION:

  • Organize daily work for all members of assembly
  • Perform all inventory transactions within the manufacturing resource planning system.
  • Print all labels required by assembly work orders.
  • Validate all packaging work orders before they move to shipping.
  • Performs assembly work of a highly repetitive nature
  • Capable of operating all specified manual, semi-automated or automated labeling, heat sealing/shrinking, bagging, folding, boxing, lifting or moving equipment according to standard operating procedures.
  • Performs preventative maintenance when necessary on manual, semi-automated or automated labeling, heat sealing/shrinking, bagging, folding, boxing, lifting or moving equipment.
  • Knows and follow all job specific document control, product/kit storage and product/kit transfer procedures.
  • Can set up and use any counting or weigh scale and train chemical packager in this function.
  • Assists in the training of chemical packager on basic job functions and procedures.
  • Has good understanding of various types and configurations of kits/products and can lead a team of assemblers in the satisfactory completion of a project requiring more then one person.
  • Can work independently on any assembly project
  • Can assist material handler in moving, rearrange or organizing Finished Subassembly (FSA) and/or RM storage locations.
  • With some direction can step in for material handler in pulling and staging materials as needed.
  • Under direct supervision can assist assembly supervisor administratively by entering data in a computer system to maintain or track projects.
  • Under direct supervision can generate labels for assembly events.

EXPERIENCE AND QUALIFICATIONS:

  • Assists material handler in moving, rearrange or organizing Finished Subassembly (FSA) and/or RM storage locations
  • Required to participate in any Inventory cycle or physical count program
  • Reliable attendance
  • Follows direction and instructions accurately
  • Asks questions and learns quickly
  • Strong attention to detail
  • Good hand-to-eye coordination
  • Maintains a steady work pace
  • Works well in a team environment
  • Personable and has a positive attitude.
  • Working knowledge in the use of a computer system.
  • High school diploma or general education degree (GED); or Twelve to eighteen months related experience and/or training; or equivalent combination of education and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

24) Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) P111AY

DESCRIPTION:

  • Seeking a Research Associate to work on biological sample (human and animal plasma) analysis using existing proprietary ELISA methods, following a validated method, as well as some kit-based ELISA analysis.  
  • May also be some occasional  ELISA method development work.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with Excel and GraFit
  • Experience with ELISA assays
  • Biological/ large molecule experience
  • Cable of precise hand pipetting
  • Detail oriented and meticulous
  • Strong work ethic and dedicated to quality
  • Experience with spreadsheet manipulation and use of curve-fitting software.
  • Bachelors degree in biology or related science 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

25) Metrology – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) XR111A

DESCRIPTION:

  • Review of calibration records for completeness and compliance
  • Determination and implementation of corrective action of calibration deficiencies
  • Evaluation and improvement of calibration/preventive maintenance programs, including calibration software (CalMAN) functionality and capability. 
  • Support for operations and documentation in facilities, quality control and quality assurance areas.

EXPERIENCE AND QUALIFICATIONS:

  • Work history must be in the FDA regulated industries, i.e. drug, biotech, device
  • Thorough understanding of calibration principles and practices required
  • Hands-on work experience as calibration program administer highly desired
  • Hands-on work experience for QC calibration program highly desired
  • Working experience of CalMAN or similar calibration software a plus
  • Past role in facility engineering, QA or QA helpful

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

26) Senior Product Data Steward – Contract (Oregon) 73G5297

DESCRIPTION:

  • Administer new part set up and part changes to ensure part changes and related documentation are reviewed and approved prior to implementation.  
  • Administration of the change control system consists of initiating and tracking all incoming, in-process and completed change requests, tracking all associated supporting documentation and following up to ensure the changes are completed and documentation is properly closed out.
  • Responsible for project managing the process of change control
  • Communicates with internal customer to collect product related information
  • Manages the change request workflow, which is the vehicle to send request for changes
  • Manages the change workflow, which is the vehicle to execute the request for changes
  • Maintains accurate records of all in-process Product change orders & Document Change Orders (admin function)
  • Provides end-users status updates on their requests
  • Executing product data changes for approved changes orders in site support systems
  • Runs report and queries related to the change management activities
  • Responsible for all changes related to sku discontinuation
  • Initiate Master Data updates as necessary, ensuring completion of corrections.
  • Maintain Quality Records in compliance with ISO Standards.
  • As necessary, evaluates ERP system data to verify accuracy.
  • Will take part in mass data updates as well as ERP system and report modification testing.
  • Provide OJT training for new team members.
  • May be required to perform other related duties as required and/or assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Works independently on new and on-going assignments
  • Identifies and solves problems using established business rules and procedures
  • Detail oriented
  • Good verbal and written communication skills
  • Continuous improvement minded
  • Comfortable with ambiguity and change
  • Requires a minimum of 2 – 4 years relevant experience in a data management, manufacturing, planning, or quality role in a change control environment.  
  • Knowledge of computer applications and current software is desirable (Microsoft Excel, Outlook, Word, Access, Project and PLM/ERP system
  • Associate’s degree from accredited college/university or equivalent experience.  
  • Applied technical knowledge of PLM and ERP/MRP systems is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

27) Project Manager – Contract (New Jersey) 2410

DESCRIPTION:

  • Must demonstrate an understanding of project and process management.
  • Must demonstrate an understanding of legal contract concepts and efficient administration and automation of contract processes.
  • Working closely with attorneys, contract managers and paralegals in different Legal Departments and others on cross-functional teams.
  • Participate in post go-live support for eBuy system.
  • Perform system monitoring during pilot and beyond.
  • Participate in eBuy team meetings as requested representing the legal department in the plans around contracts and POs.
  • Manage tasks on eBuy project plan to appropriate timeframes to ensure pilot success.
  • Participate in User Acceptance Testing of the eBuy system.
  • Contribute to business scenario development for test-scripts in eBuy system.
  • Develop SLA/ KPIs as outcomes of the eBuy pilot.
  • Contract Storage Solutions:
  • Work with the Principal Contract Manager and Analyst – Legal Data Group to create governance for contract storage, and if possible a single solution, for contract storage.  Communicate solutions to key stakeholders.
  • Improve Contract administration processes and templates.
  • Contract Process:
  • Participate in initiatives to streamline processes.
  • Train on new contract processes as needed.
  • Prepare communication and keep guidance documents on contract processes updated.  Work with varied stakeholders and legal departments (globally and in the US) on guidance documents.
  • Communicate to key stakeholders in different legal departments, and across different departments, on Simple Contract Management plan.
  • Working with the Principal Contract Manager, liaise between various legal teams to develop harmonized templates and processes where possible, and consider implementation of  an inventory management plan for simple contract templates. 
  • Work with Principal Contract Manager to write local governance for simple contract policy, including access management.
  • Work with Principal Contract Manager to train Trained Users (Procurement and others ) on simple templates, their management and storage.  Identify solution for maintaining list of Trained Users.
  • Work with the Principal Contract Manager to create auditing mechanism for Simple and Routine contracts (work performed by departments other than Legal)
  • Help support SOx requirements of existing processes and eBuy process changes.
  • Work on harmonizing contract signature policies, revising policies and preparing training and communication materials.
  • Participate in cross-department cross-functional working groups  on this project.

EXPERIENCE AND QUALIFICATIONS:

  • Strong organizational skills.
  • Independent self-starter with ability to progress projects independently as well as work effectively on teams.
  • Strong interpersonal management skills
  • Excellent people and communication skills
  • Ability to maintain effective working relationships across departments.
  • Must be detail-oriented, analytical and a forward thinker
  • Results-oriented.
  • 2 plus years of experience drafting and negotiating simple and complex agreements in a corporate legal or procurement department.
  • 2 plus years of project management experience.
  • Excellent written and verbal communication skills
  • Bachelor’s degree or Paralegal Certification

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

28) SAP Financial Systems Analyst – Contract (New Jersey) 9126

DESCRIPTION:


Support and maintain existing financial systems, implement enhancements, design solutions to meet the needs of the organization, and maintain financial reporting systems to effectively collect, analyze, and report data. In addition, the candidate will provide technical system analysis and propose modifications to existing data and application systems of varying levels of complexity. Determines system specifications and develops procedures and processes that improve overall accounting requirements while adhering to GAAP and IFRS reporting requirements.

Responsibilities:

  • Provide accounting and financial systems support
  • Assists in supporting  and  enhancing the SAP Financial Modules, (SAP FI, Project, Purchasing/MM, AP, FA)
  • Performs maintenance of existing financial systems, experience with validations and substitutions 
  • Develops the testing, validation, and evaluation of proposed changes to financial systems
  • Creates and maintains documentation for system changes.
  • Recommends, develops, and revises SAP & Business Warehouse reports to meet  ongoing and future reporting requirements
  • Recommends innovative solutions that provide value added solutions for the overall effectiveness of the financial systems.
  • Works with project teams during the development of new system design.
  • Lends support to the Financial group in working discussions designed to evaluate systems tools. Proposes several innovative alternatives.
  • Evaluates existing financial reports and systems design for efficiency and effectiveness, and develops tactical objectives to implement improvements (eg: BW reporting tools).
  • Identify issues resulting from systems, data or organizational changes which could impact SOX standards and or the financial organization and reports them to the attention of the appropriate individuals.

EXPERIENCE AND QUALIFICATIONS:

  • Capability to work in a regional organization with multiple clients, dealing as well with corporate/global. 
  • Skilled at working effectively and professionally with all entities.
  • Ability to influence all levels of management and other functional areas (business, finance, legal).
  • Strong internal customer & business focus, result orientation and change management experience.
  • Establishes priorities and timelines to effectively manage workload. 
  • Able to multi-task with multiple deadlines exceptionally well.
  • Identifies issues or concerns and works with others to determine an effective course of action. 
  • High degree of independent problem solving and decision making skills.
  • Excellent organizational skills and a systematic approach to work with care taken over detail and confidentiality.
  • Serve as a leader among peers and are viewed and utilized as the go-to person within their respective segment, across the department, and to internal customers.
  • Excellent written and oral communication skills, team work, computer skills and system knowledge.
  • 5-7 years experience: Extensive knowledge on SAP Financial applications with an understanding of accounting/finance including, general ledger, accounts payable, purchasing, fixed assets and project accounting.
  • Bachelor's degree from an accredited four-year college or university with an area of specialization: Expertise in SAP R3 Financial Application Modules.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

29) Buyer – Contract (New Jersey) 0504

DESCRIPTION:

  • Facilitate software purchases.  
  • Establishing MSA's/MLA's, running RFP's/bids, approving purchases, interacting with customers and assisting with their software purchases.  
  • May also need to work on projects related to IT services and IT hardware. 

EXPERIENCE AND QUALIFICATIONS:

  • Familiar with IT purchasing
  • Software purchasing experience desired
  • Contract review
  • Bidding
  • Strong customer focus
  • General skills associated with a Buyer II role
  • Bachelors degree

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

30) Senior Administrative Assistant – Contract (Maryland) 7081P73

DESCRIPTION:

  • To provide complex administrative support functions for Senior Management and the department employees ensuring efficient office operations.                                                  
  • Provide advanced assistance to a department by performing various complex administrative support functions, including but not limited to, analytical and specialized administrative duties to ensure efficient office operations.
  • Perform advanced word processing and desktop publishing to include complex presentations, reports, spreadsheets and graphs; transcribe information of a technical, confidential and/or sensitive nature; may be required to take meeting and/or conference call minutes.  
  • Draft, review and/or edit written material to ensure accuracy, neatness, correct punctuation and grammar; recommend changes to improve readability and clarity.
  • Research, compile, summarize, and analyze information to formulate correspondence and respond to various inquiries from internal and external customers.     
  • Utilize company personnel at all organizational levels to gather information to prepare reports. 
  • Screen mail and callers, respond to and route inquiries to appropriate personnel as necessary; determine importance and priority of various issues and determine what major issues should be brought to the attention of the department head and/or department members.
  • Coordinate, assist in planning, prepare agenda and monitor meetings; maintain calendar(s) and travel requests.
  • Handle highly confidential, sensitive and/or critical information, files, records and reports.
  • Actively promote and ensure clear communication within the department and facilitate inter-departmental communication.
  • Manage and coordinate projects and programs to ensure high quality end results within given timeframe.
  • May be required to perform other related duties as required and/or assigned

EXPERIENCE AND QUALIFICATIONS:

  • Excellent written and oral communication skills are required.   
  • Must be able to interface effectively within all levels of the organization.   
  • Requires a thorough knowledge of corporate operations and product line.  
  • Job encounters varying work situations, involving significant complexity.   
  • Considerable independent judgment and initiative are required in resolving problems and making recommendations.   
  • Accuracy is required in performing all functions of this position.   
  • Must demonstrate judgment, tact and diplomacy in dealing with internal and external customers as well the ability to handle highly confidential and proprietary information.   
  • Initiative and organization skills are extremely valuable to ensure a smooth office operation.   
  • Must possess self-motivation, enthusiasm, a positive attitude and perform as a team player.   
  • May determine methods and procedures on new assignments.  
  • Office/secretarial certification preferred.                                                                                                         
  • Requires a minimum of five years of related specialized administrative experience.   
  • Successful experience working with senior level management is also required.   
  • Must demonstrate exceptional computer skills and software application proficiency.     
  • Demonstrated ability to read difficult instructions and maintain written records required.  
  • Associates degree in business or similar discipline, or the equivalent knowledge and experience required. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

31) Senior Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) P111BL

DESCRIPTION:

  • Provide global medical leadership and input into all aspects of safety of assigned molecule or therapeutic area including surveillance programs, aggregate review and risk management planning.
  • Proactive safety review of aggregate safety data including signal detection
  • Support clinical team in developing safety section for protocol, informed consent, and investigator brochure
  • Participate in activities related to Independent safety data monitoring committee (ISDMC)
  • Analyze integrating safety data from completed clinical studies
  • Review and provide input on the safety section for clinical study reports
  • Develop strategy and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committee
  • Ensure timely preparation for risk management strategies (RMP, REMS), including risk minimization measures
  • Timely preparation of periodic reports (DSUR)
  • Maintain compliance with corporate policies, standard operating procedure and global regulation
  • Lead the discussion on safety issue cross-functionally
  • Participate in development, review and update of safety exchange agreement with collaborators
  • Prepare and participate in regulatory review meetings
  • Participate in audits and inspection
  • Prepare and share safety information with licensing partners, review safety documents prepared by licensing partners, communicate safety matters with partners per the safety data exchange agreement
  • Provide training, coaching and mentorship to safety scientists
  • Represent and champion the role of safety in the organization

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of processes and global regulations governing pharmacovigilance and risk management
  • Drug development
  • Safety data capture
  • MedDRA and other dictionary used in pharmacovigilance
  • Knowledge of methods of qualitative and quantitative safety data analysis
  • General medicine, epidemiology, physiology and pharmacology
  • Signal detection, aggregate data analysis and evaluation
  • Good clinical and scientific judgment
  • Strategic thinking and leadership
  • Effective team work, influencing and negotiation in a cross-functional environment
  • Ability to work with collaborators and licensing partners
  • Good organizational skills,
  • Strong leadership ability in negotiation, communication and networking
  • Problem solving
  • Develop solutions in coordination with key decision makers
  • Executes goals and department strategy
  • Detailed knowledge of current pharmacovilance environment, regulations and processes
  • MD, DO or equivalent from accredited medical school
  • 7+ years in the pharmaceutical or biotech industry
  • 5+ years in drug safety and pharmacovigilance
  • Experienced managing/supervising staff

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

32) Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) TM111Z

DESCRIPTION:

  • Provide global medical leadership and input into all aspects of safety of assigned molecule or therapeutic area including surveillance programs, aggregate review and risk management planning.
  • Proactive safety review of aggregate safety data including signal detection
  • Support clinical team in developing safety section for protocol, informed consent, and investigator brochure
  • Participate in activities related to Independent safety data monitoring committee (ISDMC)
  • Analyze integrating safety data from completed clinical studies
  • Review and provide input on the safety section for clinical study reports
  • Develop strategy and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committee
  • Ensure timely preparation for risk management strategies (RMP, REMS), including risk minimization measures
  • Timely preparation of periodic reports (DSUR)
  • Maintain compliance with corporate policies, standard operating procedure and global regulation
  • Lead the discussion on safety issue cross-functionally
  • Participate in development, review and update of safety exchange agreement with collaborators
  • Prepare and participate in regulatory review meetings
  • Participate in audits and inspection
  • Prepare and share safety information with licensing partners, review safety documents prepared by licensing partners, communicate safety matters with partners per the safety data exchange agreement
  • Provide training, coaching and mentorship to safety scientists
  • Represent and champion the role of safety in the organization

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of processes and global regulations governing pharmacovigilance and risk management
  • Drug development
  • Safety data capture
  • MedDRA and other dictionary used in pharmacovigilance
  • Knowledge of methods of qualitative and quantitative safety data analysis
  • General medicine, epidemiology, physiology and pharmacology
  • Signal detection, aggregate data analysis and evaluation
  • Good clinical and scientific judgment
  • Strategic thinking and leadership
  • Effective team work, influencing and negotiation in a cross-functional environment
  • Ability to work with collaborators and licensing partners
  • Good organizational skills,
  • Strong leadership ability in negotiation, communication and networking
  • Problem solving
  • Develop solutions in coordination with key decision makers
  • Executes goals and department strategy
  • Detailed knowledge of current pharmacovilance environment, regulations and processes
  • MD, DO or equivalent from accredited medical school
  • 5+ years in the pharmaceutical or biotech industry
  • 3+ years in drug safety and pharmacovigilance

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

33) Director CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) XF132H

DESCRIPTION:

  • Responsible for ensuring the CMC regulatory strategy is in alignment with the global regulatory strategy and leading and coordinating the  process for compiling the CMC section of regulatory submissions.
  • Work with cross-functional project teams to develop CMC regulatory strategy and ensure success of regulatory filings.
  • Reviews CMC documentation to ensures they meet regulatory requirements.
  • Represents RA CMC  at project team meetings and coordinates regulatory  workflow between departments as well as CROs
  • Coordinates, writes, compiles  CMC  document packages and investigational drug shipment related activities  for  drug manufacturing  according to regulations/guidelines and company SOPs
  • Participates in specification committee meetings and reviews/approves specification changes.
  • Assembles, coordinates and compiles technical documents needed to complete CMC section of regulatory submissions.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
  • Coordinates drafting of responses to regulatory questions in a timely manner.
  • Reviews Change controls and provides regulatory impact assessment. Ensures appropriate regulatory filings are completed in a timely manner.
  • Participates in Regulatory Affairs initiatives to improve standards and systems.
  • Escalates issues that affect registration, and regulatory compliance to CMC Regulatory Affairs Management

EXPERIENCE AND QUALIFICATIONS:

  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
  • Proficient with computer (MS Office) and internet skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
  • Proven ability to communicate with executive management, cross-functional team members and operational staff.
  • Flexible attitude with respect to work assignments, and new learning.
  • 8+ years relevant regulatory CMC  experience
  • BS and advanced degree in life sciences (MS, PhD or PharmD or equivalent)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

34) Manager / Sr. Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B132WN

DESCRIPTION:

  • Responsible for ensuring the CMC regulatory strategy is in alignment with the global regulatory strategy and lead/coordinate the process for compiling CMC section of regulatory submissions.
  • Reviews CMC documentation to ensures they meet regulatory requirements.
  • Represents RA CMC at project team meetings and coordinates regulatory  workflow between departments as well as CROs
  • Coordinates, writes, compiles CMC document packages and investigational drug shipment related activities for drug manufacturing  according to regulations/guidelines and company SOPs
  • Assembles, coordinates and compiles  technical documents needed to complete CMC section of regulatory submissions.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
  • Coordinates drafting of responses to regulatory questions in a timely manner.
  • Assists in the review of change controls and provides regulatory impact assessment as needed. 
  • Ensures appropriate regulatory filings are completed in a timely manner.
  • Participates in Regulatory Affairs initiatives to improve standards and systems.
  • Escalates issues that affect registration, and regulatory compliance to CMC Regulatory Affairs Management

EXPERIENCE AND QUALIFICATIONS:

  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
  • Proficient with computer (MS Office) and internet skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
  • Proven ability to communicate with executive management, cross-functional team members and operational staff.
  • Flexible attitude with respect to work assignments, and new learning.
  • 6+ years relevant regulatory CMC  experience
  • BS in Chemistry. 
  • Advanced degree preferred. (MS, PhD or PharmD or equivalent)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

35) Director / Sr. Director, Regulatory Affairs – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G129FS

DESCRIPTION:

Responsible for global regulatory leadership, management and strategic guidance for all regulatory aspects (nonclinical , clinical, CMC) of one to two development stage programs. The responsibilities of this position include defining, implementing and delivering the global regulatory strategy for assigned programs. The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development and be able to provide guidance in interpreting these rules, regulations, and guidelines. Strong leadership, communication (written and verbal), and management skills are required with a hands-on, can-do attitude.

Responsibilities:
 
  • Develop and implement U.S. and ex-U.S. regulatory strategies and act as a regulatory lead to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance including with manufacturing, research, clinical, and quality assurance.
  • Act as the primary contact for regulatory licensing matters.
  • Review labeling and promotional materials throughout the product lifecycle and communicate labeling changes to all stakeholders.
  • Interact cross-functionally with members of commercial, legal, safety, clinical, manufacturing, quality, medical, and others
  • Plan, coordinate and prepare documents that are submitted to US and international regulatory authorities in support of INDs, BLAs, DMFs CTAs, NDAs and necessary amendments, safety reports, and annual updates.
  • Ensure that regulatory expectations are clear to all internal and external stakeholders (including partners, CROs, consultants and contractors) in order to execute program objectives in compliance with applicable regulations.
  • Represent the Company externally in scientific, financial and business development communities, and in meetings with regulatory agencies serve as a credible, influential, respected corporate spokesperson during all interactions with regulators and regulatory agencies.
  • Ensure regulatory submissions are completed on time by working with project teams to gather the information and documents necessary to file complete and accurate submissions in accordance with corporate goals.
  • Continue positive communications and rigorous interaction with the FDA and other regulatory agencies and ensure activities meet all relevant requirements & guidelines.
  • Identify potential compliance issues and work with respective functions in developing corrective action plans to ensure compliance is achieved.

EXPERIENCE AND QUALIFICATIONS:

  • BS, MSc, or Ph.D. degree in the life sciences with a minimum of 15+ years in drug development in the pharmaceutical/biotechnology industry in the regulatory function.
  • Large Molecule/ biologics experience required
  • Thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development.
  • Experience with planning and filing license applications (NDA, BLA, MAA). 
  • Experience with electronic submissions is desired.
  • Must have experience filing a minimum of one license application.
  • Working knowledge of FDA regulations is required as well as experience supporting global clinical studies.  
  • EU experience preferred
  • Experienced self-motivated individual with a record of achievement as a result of past initiatives in submitting successful IND9S) to NDA(s)
  • Regulatory experience in the review of labeling and promotional material.
  • Willingness to handle day-to-day functions while still providing the high-level strategic guidance.
  • Open, available, transparent communicator, able to develop a culture of teamwork and collaboration.
  • Able to develop and maintain excellent working relationships with global health authorities
  • Experience working with project teams and will be well versed in regulatory terminology with the ability to communicate with experienced regulators in the various governmental agencies.
  • Must possess strong leadership, presentation and influence skills.
  • Must possess excellent written and verbal skills (articulate and persuasive).
  • Able to advance group goals to meet company objectives.
  • Able to provide expertise in shaping company direction.
  • Experience at small or start-up company.  
  • Ability to be both strategic and hands on.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

36) Associate Director / Sr. Manager Clinical Supply Chain – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JQ111V

DESCRIPTION:

Ensures that all clinical trials have timely and adequate supply for administration to subjects. The Clinical Supply Chain group is involved in a clinical trial from the early stages of inception to study closure. The AD role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, and return or destruction. Additionally the manager implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the team when needed.

Responsibilities:
  • Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time managing clinical labeling including label design and manufacturing        
  • Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts
  • Importing and exporting clinical trial material.
  • Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution 
  • Setting up Integrated Voice and Web Response Systems with the clinical team.
  • Interfacing between the CMC and clinical teams.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with clinical blinding practices.
  • Experience setting up Integrated Voice and Web Response Systems.
  • Working knowledge of drug development process (Phase I-IV).
  • Working knowledge of cGMPs.
  • Experience with clinical labeling, packaging and distribution including cold chain, importing and exporting
  • Strong analytical and problem solving skills.
  • Ability to handle multiple projects simultaneously.
  • Proven project management skills.
  • Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.        
  • Use of Microsoft Office including Word, Excel, PowerPoint, Visio and Microsoft Project.
  • BS/BA degree.
  • Minimum 3 - 9+ years industry experience in clinical operations or supply chain management. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

37) Project Coordinator – Contract (New Jersey) 9044

DESCRIPTION:

  • Provide administrative support to the project team
  • Assist with scheduling workshops/meetings at multiple locations, including arranging multi country video conferencing sessions
  • Organize training sessions, track training logistics and maintain completion records.
  • Maintain documentation in project repository
  • Assist in domestic and international travel arrangements and expense report preparation
  • Support project team in printing and filing project documentation as needed
  • Order and maintain office supply inventory
  • Assist with AED/PO creation and tracking of project spend
  • Support the preparation of presentations/spreadsheets and meeting minutes
  • Maintain project team calendars
  • Project assistance, data entry and other project support requests as needed.
  • Provide support to Health and Wellness team.
  • Primary role will be to co-ordinate our initiatives with main locations
  • Close supervision will be provided by Director Employee & Wellness

EXPERIENCE AND QUALIFICATIONS:

  • Strong Excel, PowerPoint, and Microsoft Outlook skills
  • Ability to work independently and to provide support to individuals in multiple locations
  • Must have advanced knowledge of or ability to quickly learn internal electronic systems to facilitate completion of tasks (Sharepoint, Webex, Cliqbook/Concur, eRoom etc.)
  • Strong writing and communication skills
  • High School Diploma and 5+ years administrative experience
  • Associates Degree and 5+  years of experience supporting multifunctional department & leaders a plus
  • Minimum 5+ years of experience using computer technology including the Microsoft Suite of tools (Outlook, Excel, Powerpoint, Word and others)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

38) Senior Clinical Biometrics Analyst – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R109AX

DESCRIPTION:

  • Helps to provide detailed analysis on clinical and operational performances to be used for optimization of clinical operations and efficiency.  These data will influence decisions on ongoing and future clinical initiatives and realignment of operational processes.
  • Answer clinical and operational questions by using appropriate statistical techniques on available data
  • Prepare, verify and manager datasets; develop accompanying documentation
  • Conduct independent analysis of high complexity under minimal supervision and guidance
  • Query from complex patient database with clinical data based upon understanding of the need for information or other provided specifications
  • Create system QA processes; conduct robust programming and data quality checks to ensure data integrity
  • Create and execute work plans with involved data processes or analyses
  • Develop analysis and reports using understanding of the business need for information
  • Critically review and revise existing analytical process for accuracy and efficiency
  • Communicate findings in the form of presentations, abstracts, graphs, or summaries so that they are easily understood by non-technical audiences
  • Produce accurate work under tight deadlines
  • Accountable for the statistical input provided to all major documents, including clinical development plans, protocols, statistical analysis plans, manuscripts

EXPERIENCE AND QUALIFICATIONS:

  • Comfort manipulating and analyzing complex clinical data
  • Ability to independently design and implement analyses appropriate for longitudinal data
  • Expert knowledge of SAS for analysis, graphical output and standardized reporting
  • Must be able to perform complicated data merges and develop programs and scripts that can be used to generate reliable results over time
  • Experience solving analytic problems using quantitative approaches
  • Familiarity with relational databases
  • Ability to communicate quantitative analysis in a clear, precise and actionable manner
  • Strong organizational and documentation skills; must work on multiple tasks simultaneously
  • Self-motivated, with ability to work independently with minimal supervision or collaboratively with a small team.
  • MS in math/biostatistics or related field with at least 3-5 years of experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

39) Sr. Administrative Assistant – Contract (Southern California) 73P0412

DESCRIPTION:

  • Coordinate, assist in planning and prepare agenda and monitor meetings
  • Maintain calendar(s) and travel requests. 
  • Provide advanced assistance to a large, global department by performing various complex administrative support functions, including but not limited to, analytical and specialized administrative duties to ensure efficient office operations. 
  • Perform advanced word processing and desktop publishing to include complex presentations, reports, spreadsheets and graphs; 
  • Transcribe information of a technical, confidential and/or sensitive nature; take meeting and/or conference call minutes. 
  • Draft, review and/or edit written material to ensure accuracy, neatness, correct punctuation and grammar; recommend changes to improve readability and clarity. 
  • Research, compile, summarize, and analyze information to formulate correspondence and respond to various inquiries from internal and external customers. 
  • Monitor mail and callers, respond to and route inquiries to appropriate personnel as necessary; determine importance and priority of various issues and determine what major issues should be brought to the attention of the department head and/or department members. 
  • Handle highly confidential, sensitive and/or critical information, files, records and reports. 
  • Actively promote and ensure clear communication within the department and facilitate inter-departmental communication. 

EXPERIENCE AND QUALIFICATIONS:

  • Excellent written and oral communication skills are required.
  • Experience managing a complex, global calendar in Outlook
  • Experience arranging international travel
  • Experience with taking meeting notes and sending out/following up on action items
  • Experience with international meeting planning; will work with other admins
  • Excel and PowerPoint experience
  • Requires excellent communication skills and ability to work with high executives.
  • A minimum of 8 years of experience as an Executive Assistant in a large, dynamic corporate environment
  • Bachelors degree in business or similar discipline, minimum of 8 years of experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

40) Clinical Trial Manager – Contract (New Jersey) 9049

DESCRIPTION:

  • Support Medical Affairs by managing investigator-sponsored trial operations and ongoing quality improvements in the processing and review of ISTs. 
  • Liaise with field medical teams, medical strategy, legal, and other departments as needed to ensure investigator sponsored trial requirements are met or exceeded.
  • Coordination of concept submissions to cross-functional committee review teams, forecast and tracking of study budgets and milestones, ensure timely distribution of investigator Letters, oversee that study progress is tracked and reported to the cross-functional team, ensure clinical trial databases are maintained, and actively participate in process improvement initiatives, task forces, and committees within Clinical Operations.
  • Participate in the review and critique of investigator-sponsored trial protocols for compliance with company policy and alignment with corporate strategy.
  • Track the execution of the ISTs and budgets from approval decisions through execution of contract payments, and outcomes.
  • Critically evaluate budgets for proposed ISTs.
  • Maintain an accurate and current database on the status of all ISTs.
  • Participate in cross-functional teams and ensure working teams meet frequently to evaluate IST progress and provide feedback
  • Provide mentoring to Clinical Trial Associates in study management and conduct of clinical trials, as appropriate
  • Demonstrate functional knowledge of Good Clinical Practices, corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines

EXPERIENCE AND QUALIFICATIONS:

  • Preferred candidates will have IST experience
  • Oncology, diabetes, cardiovascular experience preferred.
  • Ability to manage multiple projects and work across functions in a matrix organization 
  • Excellent organization and tracking skills. 
  • Proven ability to work both independently and in a team setting, and to meet set goals by managing own timelines 
  • Able to proactively identify and propose solutions to operational activities 
  • Strong oral and written communication skills 
  • Strong and consistent attention to detail 
  • Knowledge of Good Clinical Practice; solid knowledge of clinical trial design; understanding of the overall drug development process 
  • Basic knowledge of principles for trial budgeting is preferable
  • Understanding of highly regulated pharmaceutical industry environment 
  • Embodies vision, competencies, and values
  • 2-3 years or equivalent cross-functional team experience in project and / or portfolio management  
  • Involvement in cross-functional clinical trial teams; demonstrated capabilities in supporting trial planning, initiation, executing, and reporting activities.
  • Minimum of 4 years industry experience in a multidisciplinary Clinical, Research and/or Clinical Operations environment (e.g. pharmaceutical industry, a CRO or academic institution)
  • Minimum of a BSN, BA or BS in a scientific discipline and at least 4 years of clinical research experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

41) Manager, Clinical Supply Chain – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132BN

DESCRIPTION:

Summary:
Manage global clinical drug supply activities such as secondary packaging vendor selection, technical batch record review, clinical label design, label translation coordination, packaging and labeling, IXRS oversight, distribution tracking, product returns and destruction coordination.  Manage secondary packaging vendors to ensure timelines are met.  Provide Supply updates at weekly Study Management and Vendor Team meetings. 

Responsibilities:
  • Supply support for Clinical Operations
  • Manage select clinical drug supply activities
  • Provide supply input on study protocols
  • Identify secondary packaging suppliers based on clinical product requirements
  • Attend weekly Study Management Team meetings
  • Conduct weekly vendor update calls
  • Provide status updates to Clinical Operations
  • Coordinate clinical label text review and approvals
  • Coordinate clinical label translations for global studies
  • Perform technical packaging batch record review
  • Oversee packaging at secondary packaging sites
  • Ensure packaging timelines are met
  • Ensure products are released by required dates
  • Coordinate product shipment/transfers with vendors and Logistics
  • Temperature excursion management/evaluation
  • Coordinate post study product return activities
  • Update/develop required Clinical Drug Supply SOP’s
  • Establish Clinical Supply set up requirements
  • Generate required SOP’s

EXPERIENCE AND QUALIFICATIONS:

  • Previous Clinical Drug Supply experience required
  • Understanding of cGMP’s and pharmaceutical industry procedures and regulations.
  • Ability to plan, budget and organize.
  • Strong, open and transparent communication skills (verbal and written).
  • Solid organizational and time management skills.
  • Project management skills and computer proficiency.
  • Experience with:  MS Excel, Word, Project.  
  • Bachelor’s degree in business or biological sciences with minimum of 5 years experience in GMP supply chain or pharmaceutical program management.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

42) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 1144F73

DESCRIPTION:


  • Create new SKUs using SKU wizard
  • ECO request of new part release through Agile
  • Write processing documents
  • Support work related to SAP and Agile database
  • Work with various stakeholders: following up the progress of ECO, and facilitating the resolution of any issues.
  • Support Tech Transfer group in lab testing of assays.

EXPERIENCE AND QUALIFICATIONS:

  • Familiar and experienced with SAP and Agile.  
  • If only experienced in SAP, familiar in general ERP system to be trained on Agile quickly. 
  • Basic knowledge in ERP system is must.
  • Requires a Bachelor's degree in Biology, Chemistry, Biochemistry, or other related discipline, or the equivalent knowledge and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

43) Senior Clinical Data Manager – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G129RX

DESCRIPTION:

Position Summary:

Provide expertise for data management activities related to the preparation and implementation of clinical trials. This position works closely with Biostatistics and Programming, Clinical Operations, Regulatory and other related disciplines to support database development and provide reporting for all clinical studies. Further, this position works closely with other project team members within Clinical Research and Regulatory Affairs, as well as with outside vendors and CRO’s.

Responsibilities:
  • Provide oversight/management (of CRO’s) and participate in study set-up and initiation procedures such as eCRF design, database design, edit check design/review, and data management plan review
  • Ensure proper clinical data review and query management
  • Assist in developing data management guidelines and quality processes to ensure databases are accurate
  • Review data and initiate corrective and preventive actions regarding data discrepancies
  • Run reports in EDC (e.g., TrialMaster, OC RDC)
  • Participate in other activities and meetings to support Biostatistics, Clinical Operations, and the development team as needed
  • Provide training on reports to reviewers
  • Process requests for new reports and identify needs for new reports
  • Assess changes to eCRFs, eCRF Completion Guidelines, DM plans, etc.
  • Review invoices and accruals

EXPERIENCE AND QUALIFICATIONS:

  • Experience in clinical trials through Phase 3 (NDA submission) 
  • Data management experience using TrialMaster and Oracle Clinical EDC preferred
  • Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, and Outlook)
  • Experience in the design and management of clinical trial databases using TrialMaster and Oracle Clinical EDC, as well as reporting capabilities
  • Familiarity with ICH GCP as well as general knowledge of industry practices and standards such as CDISC-SDTM data standardization specifications
  • Ability to anticipate and escalate issues in a timely manner and define appropriate action plans
  • Strong vendor management skills required
  • SAS programming a plus
  • Bachelor’s degree in the scientific, biological, statistical or computer science field or related discipline
  • At least five years of clinical trial data management experience in the pharma/biotech industry

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

44) Admininistrative/Professional – HR – Contract (New Jersey) 9919

DESCRIPTION:

  • Answers general questions and redirects misplaced calls.
  • Uses procedures, policies, knowledge database and other reference materials to assist in answering employee, manager and agency HR, payroll or benefits representative inquires.
  • Guides employees and managers on using the on-line Knowledge Base tool.
  • Receives and processes employee data change requests or appropriately escalates issues.
  • Collects and validates complete data required to process manual employee personal and organizational transactions and escalates the completed data to the center for processing.
  • Escalates complex issues/inquires to other parts of HR or redirects calls to ITS or other appropriate groups.
  • Provides support and coaching to peers.
  • Participates in continuous improvement workshops and projects

EXPERIENCE AND QUALIFICATIONS:

  • Specific focus on bilingual French/English candidates.
  • Ability to follow strict policy guidelines.
  • Ability to navigate computerized data entry system and other relevant applications.
  • Ability to recognize situations requiring call escalation.
  • Ability to follow standard procedures and scripts without variation.
  • HRIS experience preferred.
  • Strong oral communication skills.
  • Strong listening skills.
  • Strong customer service focus.
  • One or more years of general HR experience.
  • High School Degree or equivalent work experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

45) CBT Developer / LMS Administrator – Contract (Southern California) 73R4156

DESCRIPTION:

  • Heavy eLearning creation, on-boarding, modernize product training library, 
  • Run weekly reports and LMS administration. 
  • Develop various complex on-line courseware typically of a confidential nature. 
  • Perform advanced, spreadsheet/database verification; deal with information of a technical, confidential and/or sensitive nature. 
  • Support training materials using company styles, standards, and development tools. 
  • Ensure that all information is consistent, easy to understand, and well organized. 
  • Proofread and edit own work and work of others to improve quality, readability

EXPERIENCE AND QUALIFICATIONS:

  • Requires good oral communication and customer service skills in identifying needs and implementing effective solutions that satisfy various customers. 
  • PowerPoint, Articulate, FireFly, Mzinga LMS administration, Note Pad, DreamWeaver, Microsoft Excel pivot table/vLookup, iPad/iPhone web interactivity, HTML5, video editing using Adobe Premier, and Camtasia.
  • Bachelors degree in business or similar discipline, or the equivalent knowledge and experience required. 
  • Office/secretarial certification preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

46) Accountant – Contract (Southern California) 1790T73

DESCRIPTION:

  • Review general ledger activity, researching and correcting account discrepancies.
  • Research and resolve any reconciling items on a monthly basis.
  • Coordinate accounting entries with other departments and accounting system modules.
  • Generate general ledger and financial reports from the accounting system and review for accuracy.
  • Completing special projects as requested.
  • Must be able to interface effectively with all levels of company employees.
  • Requires a functional knowledge of corporate operations.
  • Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity.
  • Accuracy is required in performing all functions of this position.
  • Must demonstrate judgment, tact and diplomacy in dealing with internal and external customers as well the ability to handle confidential and proprietary information.
  • Initiative and organization skills are extremely valuable to ensure a smooth office operation.
  • Must possess self-motivation, enthusiasm, and a positive attitude and perform as a team player.

EXPERIENCE AND QUALIFICATIONS:

  • Advanced proficiency in Microsoft Excel (i.e. pivots, vlookup, etc)
  • General working knowledge of accounting ERPs such as JD Edwards and SAP
  • Attention to detail
  • Ability to work well under time constraints
  • A quick learner and problem solving skills to succeed in a very dynamic, fast-paced environment
  • Bachelors Degree in Accounting required or equivalent education
  • General knowledge of US generally accepted accounting principles
  • At least two (2) years of corporate accounting experience, with some public accounting firm experience preferred but not required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

47) Technical Writer – Contract (Pennsylvania) 4062

DESCRIPTION:

  • Technical writing and updating of cGMP documents.  
  • Driving a document through review and approval states, which means dealing with other support groups.
  • Able to complete assigned tasks independently

EXPERIENCE AND QUALIFICATIONS:

  • In depth knowledge of MS Office Programs
  • Microsoft word – high skill level (technical editorial support)
  • TrackWise – Global and North American
  • SAP experience
  • Detail oriented
  • edoc experience preferred
  • Articulate communication skills
  • College degree preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

48) QA Technical Writer – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) PG127A

DESCRIPTION:

Description:

Responsible for researching, writing and editing CMC related reports, summarizing data from process development studies for submissions to the FDA and for publication and/or presentation. Will also assist in the development of formats and guidelines for CMC documentation. Remains informed of the latest professional, technological, and regulatory developments in CMC writing. Closely work with process chemists to evaluate organize data and write summary reports. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods and techniques. May acts as a writing liaison to other teams. Assists with the planning for document development. Creates tables, graphs, and flowcharts. Develops documents that are written according to approved style guidelines and adheres to a high standard of accuracy. Ensures that reports adhere to standard format, terminology, and style. May review the work of others and assist in managing the flow of work. Assists in identifying process improvements and in building the CMC writing infrastructure.

Responsibilities

  • Support the preparation and review of the annual product review report function for US and EU.
  • Oversee the preparation of the management reviews reports as assigned
  • Support quality performance metrics and significant quality events to Sr. Management
  • Review technical and/ or approval of technical reports, including, but not limited to drug development and process controls, technology transfer, stability, process validation.
  • Support quality during or supplier regulatory inspections
  • Writing or approving standard operating procedures, policies, specifications, and regulatory submissions or other controlled documents
  • Participate in other quality improvement and risk management projects as assigned
  • Document control support
  • Other duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • An ability to create effective presentations from raw data is essential.
  • An ability to interpret experimental data is essential.
  • Must have ability to work well with others in high-pressure situations.
  • Must have demonstrated problem solving abilities.
  • Strong organizational skills are required.
  • Strong written and verbal communication skills are required.
  • A basic understanding of Process Development, CGMP, and regulatory affairs is required.
  • Must have experience writing CMC sections of regulatory submission documents and sections.
  • Good computer skills are required.
  • In depth working knowledge of MS word, Excel, PowerPoint is a must.
  • A minimum of 5 years of reports writing experience is required. 
  • A minimum of 2 year’s experience in a pharmaceutical, biotech, or CRO technical writing position is required.
  • A minimum of a Bachelor’s degree in Chemistry or related discipline is required. 
  • Equivalent experience may be accepted.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

49) QA Expert (Principal Quality Representative) – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) F127JN

DESCRIPTION:

  • Responsible to represent QA at a GMP manufacturing site and for the review and approval of production and quality documents and records, including but not limited to, master batch records, executed batch records, deviations, CAPAs, procedures, change controls, component and drug substance/drug product specifications.
  • Interacts with manufacturing Quality and Production operations staff and management to provide real time GMP manufacturing guidance and decisions for critical drug product manufacturing operations.
  • Provide QA person-in-the-plant support of GMP drug product manufacturing, performing real-time batch record review and production oversight as required
  • Provide accurate and timely final drug product and drug substance lot dispositions
  • Review and approve pharmaceutical manufacturing and testing deviations and investigations and deliver associated deviation/CAPA tracking, follow-up, and effectiveness assessment
  • Review and approve GMP documents and specifications
  • Collect data, analyze, and report on contract manufacturing trends for Annual Product Review or Management Review
  • Identify and propose quality and manufacturing process and system improvements
  • Attend on site meetings with contract manufacturing teams to represent  quality and/ or cGMP regulatory needs

EXPERIENCE AND QUALIFICATIONS:


  • Ability to maintain diplomatic and productive business environment at all levels
  • Ability to work independently
  • Experience writing pharmaceutical quality deviations
  • Min. 15 years’ experience in cGMP pharmaceutical quality assurance or manufacturing
  • Superior attention to documentation and record detail
  • Ability to prioritize and balance efforts between major and minor issues
  • Understanding of the drug development process, pharmaceutical quality systems, drug release testing, stability, and equipment maintenance and process validation
  • Understanding of ICH Good Manufacturing Practices regulation concepts
  • Prefer Bachelor’s degree or higher in science, engineering, pharmaceutical sciences, or chemistry

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

50) Associate Manager / Manager, Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa) OT127Z

DESCRIPTION:

  • Responsible for supporting regulatory activities, will write and prepare IND/NDA documents, contribute to the completion of projects, assist with development programs, and ensure compliance with required FDA regulations.
  • Write and prepare regulatory documents for submission to the FDA (specifically for INDs and NDAs).
  • Review technical documentation.
  • Assist with development programs.
  • Maintain regulatory records, including archive of submissions and FDA correspondences files.
  • Maintain up-to-date regulatory knowledge, including regulatory procedures and changes.
  • Responsible for making sure submissions comply with applicable regulations and guidance documents.
  • Track submissions and ensure timely filing of documents.
  • Liaison with other internal departments regarding documentation and submissions.
  • Manage project deliverables and timelines.
  • Conduct or participate in meetings with internal teams and government agencies.
  • Distribute agendas, take minutes and assign/follow up on action items.
  • Ensures all assignments are completed within defined timelines and meet regulatory and other company guidelines.
  • Other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Direct IND and NDA submission experience required.
  • Intermediate understanding and utilization of regulations and guidances.
  • Experience with pharmaceutical drugs is required; small molecules a plus.
  • Ability to work independently.
  • Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners.
  • Must be flexible when priorities change and have the ability to complete tasks with a sense of urgency.
  • Excellent written and verbal communication skills.
  • Must be able to work successfully within a team.
  • 4-year degree in Biological Sciences, Chemistry or Engineering required.
  • Experience: 3-5+ years of direct, recent experience in Regulatory Affairs.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

51) Clinical Research Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B127HY

DESCRIPTION:

  • Assists with the implementation and conduct of clinical studies, focusing on the areas of protocol development, study planning, site monitoring and/or monitoring management, enrollment, data quality and study reporting. The work for this position takes place in an office and not a lab. 1-2 years’ experience as a CRA required.
  • May lead small operational study teams, i.e. act as sponsor-CRO liaison or Lead CRA for a particular study.
  • Prepares study documents for assigned studies, e.g. consent and assent templates, site reference materials, site monitoring plan, pharmacy manual. Prepares materials for study startup or training, e.g. investigator meetings, vendor kickoff meetings, site initiation visits.
  • Responsible for communications relating to assigned studies; generates and distributes meeting agendas, minutes and status reports.
  • Manages Trial Master File (TMF) and Clinical Trial Management System (CTMS); responsible for reconciliation of the TMF when transferred from an external vendor.
  • Participates in the review of clinical documents (i.e. protocols, amendments, clinical study reports) and clinical sections of regulatory submissions (i.e. IND annual reports, IND and NDA filings) for consistency and quality.
  • Participates in the identification and qualification of clinical investigators, and assists with the development of site budgets. May administer site payments.
  • Participates in the assessment and selection of vendors and their ongoing performance, i.e. tracking of contracted costs and milestones.
  • May conduct site monitoring visits, independently or as a co-monitor, and complete associated visit reports and follow-up documentation. Conducts remote monitoring, via an electronic Case Report Form (eCRF) database.
  • Assists with inspection-readiness activities for FDA or other regulatory agency, preparing either internal or external teams (i.e. investigational sites).
  • Other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Understanding of the study phases and general knowledge of how they apply to drug development. 
  • Bachelor’s degree in a biological science is preferred. 
  • Requires a minimum of 1-2 years’ experience as a CRA, with orphan drug/disease and/or pediatric knowledge very helpful. 
  • Previous experience in pharmaceutical industry required. 
  • Strong communication skills and ability to liaise with multiple regional and external colleagues is necessary. 
  • Must be able and willing to travel on a periodic basis.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

52) Account Receivable Clerk – Contract (New York) 73M3017

DESCRIPTION:

  • Cash application of daily lockbox, wire and ACH payments
  • Process intercompany settlement log
  • Generate Intercompany invoices
  • Post cash to intercompany invoices
  • Generate refund requests
  • Generate stipend and rebate requests
  • Generate commissions
  • Process tax credits
  • Process credit memos
  • Reduce unapplied cash balance
  • Process internal adjustments
  • Process credit card payments to invoices

EXPERIENCE AND QUALIFICATIONS:

  • Basic accounting.  
  • Communication both verbal and written.  
  • Computer literacy.  
  • Ability to prioritize and strong organizational skills.  
  • Must be able to multi-task. 
  • Must have an understanding of debits/credits.   
  • Accounts Receivable background is helpful.  
  • Minimal High School Diploma

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

53) Associate Director QC Team Lead – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A131AF

DESCRIPTION:

  • Plans, controls and directs QC testing operations for all product dosage forms. 
  • Oversees/manages facility/equipment utilization relative to compliance of current manufacturing processes/procedures with current Good Manufacturing Practices, health, safety and environmental policies and other federal regulations, and company policies and procedures.
  • Oversight of commercial stability programs, including activities conducted at third parties, to ensure compliance with policies.
  • Plans, organizes and directs the activities of all QC product testing functional areas, to assure that the materials released from the laboratories comply with internal and regulatory requirements, and that agreed upon target dates for work are met.
  • Oversight of third party laboratory operations to ensure compliance with policies.
  • Establishes and maintains proper compliance with cGMPs, as well as corporate/departmental SOPs (cGMP and safety); included are review of procedures to assure complete and accurate testing records, adherence to SOPs, lab failure investigations and reporting procedures.
  • Establishes QC product testing departmental objectives, establishes long-term strategy and resources requirements, and periodically reviews progress toward reaching goals, with ultimate responsibility for meeting those objectives.
  • Approves specifications/control procedures for all products and components; approves operations and QC validation protocols and reports (analytical, cleaning, process computer).
  • Helps create department and corporate quality-related policies and procedures.
  • Establishes and fosters a positive continuous improvement mentality leading to the implementation of best industry practices.
  • Interacts with the FDA, trade associations, and professional groups
  • Represents QA/QC on key cross-functional product and/or process teams and special corporate task forces.
  • Serves on all key quality-related corporate committee including recall, NORMS and GMP.
  • Ensures that all Product Testing associates have the appropriate education, experience and training (cGMP, safety, technical) to effectively, efficiently and safely complete their responsibilities.
  • Assist the Head of Quality to establish operating and capital budgets; manages operating expense budget.
  • Manage deviation and OOS process and assist in resolution.
  • Performs other duties as may be required or necessary.
  • On time delivery of analytical results
  • Laboratory compliance – deviations and audit observations
  • QC Productivity
  • On time completion of stability
  • Customer service level
  • QC compliance with training requirements

EXPERIENCE AND QUALIFICATIONS:

  • Experience leading a GMP commercial lab operation
  • Thorough knowledge of analytical principles, methodologies, and techniques utilized in the pharmaceutical QC environment.  
  • Thorough knowledge of operational functions of production, packaging, technology/MPS, materials management.
  • Thorough understanding of budgeting principles, resource management, and goals/objective setting and implementation.
  • Auditing and technical report writing experience.
  • Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and changing regulations. 
  • Experience in Deviation Management and batch disposition.
  • Experience in Change Control, validation and APR/PQR.
  • Experience with health authorities audits.
  • Proven experience with Lean, 5S, Opex, IQP applied principles
  • Very good user knowledge for Microsoft Word and Excel, SAP and Trackwise.
  • Excellent oral and written communication skills required.
  • Demonstrate leadership ability and excellent interpersonal skills.  
  • Ability to work under minimal direction, independently or as part of a team if necessary.
  • A minimum of 10 years of related pharmaceutical experience.
  • A minimum of 8 years of managerial experience in a QA/QC organization.
  • Bachelors degree in a scientific discipline is required.
  • Advanced degree is preferred. 
  • Equivalent experience may be accepted.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

54) Training Coordinator – Contract (New Jersey) 0718

DESCRIPTION:

  • Manage HR feeds
  • Load, review and test modules/curriculum in pilot, test and production environments
  • Manage module/curriculum set up
  • Launch modules and curriculums
  • Set up and run data queries and reports for business/content owners
  • Monitor post-launch feedback and answering help calls regarding access and technical issues, including elearning courses and online assessments
  • Support Instructors in the use of Learn as required (run ad hoc reports, streamline their functionality)
  • Support Reconciliation efforts/coordinate with NA Compliance to ensure compliance as needed
  • Liaise with service desk on post-launch needs
  • Creation of e-learning from content developed by training content owners as needed
  • Miscellaneous administrative support in the department related to Training and Communications

EXPERIENCE AND QUALIFICATIONS:

  • Solid experience in LMS administration and basic understanding of source system data feeds
  • Strong organizational skills, detail oriented
  • Good oral and written skills
  • Strong Microsoft Office skills
  • Experience in eLearning software such as Articulate & Captivate
  • Storyboarding and instructional design techniques a plus
  • Knowledge of web design/development and layout skills a plus
  • Training delivery experience a plus
  • Bachelors Degree preferred
  • Strong computer skills/advanced training with an emphasis on databases
  • Knowledge of and demonstrated experience with reports software, building queries, etc
  • 3-5 years experience in administrative support position in a training/learning organization
  • 1-2 additional years experience in training preferred
  • Demonstrated experience in developing and managing eLearning technologies

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

55) Patent Attorney, Director – Full Time (New York) XA130J

DESCRIPTION:

  • The candidate will function as a legal director for dispute resolution
  • Play a key role in the company’s IP enforcement strategies, including managing independently or as part of a team with other law department colleagues pharmaceutical global contentious patent proceedings, including but not limited to pharmaceutical/ biotechnology patent litigation in the US and in Europe. 
  • Manage outside counsel in non-patent litigation as needed; flexibility is required. 
  • Experience with ex parte and/or inter partes reexaminations and ex-US invalidation and opposition proceedings is a plus. 
  • The candidate will report to the Senior Director of Intellectual Property. 
  • Must be willing and able to interact and communicate well with upper management and help develop and advocate for the company’s perspective in global patent enforcement strategies with outside counsel, manage and guide outside counsel effectively, and work with counsel to manage litigation discovery. 
  • Independence and the ability to view litigation from a global perspective with the company’s long-term perspective and critically assess and direct outside counsel are important. 

EXPERIENCE AND QUALIFICATIONS:

  • The position requires excellent analytical, oral communication, and writing skills.
  • The ideal candidate will have 10+ years of legal experience, with at least 3-4 years of law firm experience or experience as a government litigator in patent litigation and at least 2-3 years of in-house experience in pharmaceutical and/or biotechnology litigation. 
  • The ideal candidate will also be able to demonstrate a strong track record of success.
  • An advanced degree in the biological sciences (e.g., genetics or immunology), or its equivalent in experience, is strongly preferred.
  • Admission to the New York bar is preferred. Attorneys not admitted in New York will also be considered under the New York’s in-house counsel registration practice.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

56) Clinical Program Manager – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B94RP

DESCRIPTION:

  • Accountable for successfully overseeing program level execution of all clinical operations deliverables, and leads the clinical program team to meet program goals and objectives.
  • Assists in the planning and execution of clinical projects while adhering to budget, scope and schedule requirements
  • Responsible for the execution of a suite of clinical trials from protocol design to the final clinical study report
  • Creates and maintains clinical program timelines for study start-up, maintenance and close-out
  • Attend clinical meetings and inform members of relevant clinical program updates
  • Ensure study timelines are met, and study progress is tracked and reported
  • Work with the clinical scientist and medical monitor to develop protocols and all documents required to initiate and conduct clinical studies (includes informed consent forms, investigator brochures, case report forms, etc.)
  • Oversee performance of CROs and/and or regional CRAs to ensure compliance to the protocol and regulations, including attending site visits, co-monitoring and review of IMV reports
  • Select and manage vendors required to conduct clinical studies (includes overseeing contracts, payments, and deliverables to ensure quality of service provided)
  • Select study investigators and evaluate adequacy to perform research and meet study timelines
  • Develop, implement, and manage project-level clinical budgets and timelines (includes communicating initial strategies and changes to project team as appropriate)
  • Develop, implement, and manage monitoring plans (may include some site visits to manage site and vendor relationships and to ensure quality of data/services)
  • Oversee study drug supply and ensure the project team is updated on all new developments or changes in supply needs
  • Identify project risks and proactively create and implement mitigation strategies
  • Collaborate effectively with cross-functional management teams and external partners
  • Communicate with management to ensure adequate resources are assigned to achieve program deliverables
  • Mentor CRAs and other operational personnel
  • May manage direct reports (contract, term &/or FTE)
  • Coordinate and participate in investigator meetings

EXPERIENCE AND QUALIFICATIONS:

  • Thorough knowledge of personal computers and MS Office Suite.
  • Knowledge of GCP and ICH guidelines required.
  • Bachelor's degree in a relevant scientific discipline or equivalent.
  • 8+ years of independent clinical trial management experience (including vendor management) as a CRA in the pharmaceutical industry and additionally 0-2 years of experience as a clinical project manager responsible for the implementation of multiple concurrent clinical trials.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

57) Scientist – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) SP111K

DESCRIPTION:

  • The successful candidate will be involved with enzyme inhibitor testing, new enzyme assay development and kinetic characterization of small molecules as inhibitors of a family of related enzymes.  
  • Additional duties may include recombinant enzyme purification by chromatographic methods, protein characterization for purity and identity, and possibly also bioanalysis by immunochemical or HPLC-UV/MS.  
  • Experience with biochem, protein biochemistry, purification, chromatography, and enzyme kinetic assays
  • Experience with enzymology, kinetics, chromatography, and bioanalysis

EXPERIENCE AND QUALIFICATIONS:

  • Highly self-motivated 
  • Strong organizational skills
  • Excellent oral and written communication skills
  • Ph.D. in the field of enzymology or related area, preferably with experience in redox related enzymes, as well as postdoctoral or industrial experience involving enzyme characterization

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

58) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) FL129B

DESCRIPTION:


  • Identify, select, and monitor investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits; review and finalize visit reports 
  • Develop and maintain good working relationships with investigators and study staff 
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures 
  • Track and report on progress of study including site activation, patient enrollment, monitoring visits 
  • Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and follow-up with study leadership to determine appropriate action 
  • Investigate queries, monitor discrepancies 
  • Manage investigational product (IP) accountability and reconciliation process 
  • Responsible for review of IP release packages 
  • Support the payments for investigative sites, if applicable 
  • Contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents 
  • Clinical data review of data listings and summary tables, including query generation 
  • Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate 
  • Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work 
  • Assist with CRA and third party vendor training on protocols and practices 
  • Assist in identification and hiring of appropriate CROs and third party study vendors 

EXPERIENCE AND QUALIFICATIONS:

  • Sponsor experience preferable 
  • Cardiovascular and/or late-stage study experience preferable 
  • Previous experience working with an electronic data capture system and CTMS system required 
  • Proficient with MS Word, Excel, Project and PowerPoint. 
  • Experience with MS Access and MS Project a plus 
  • Strong interpersonal, communication (written and verbal), and organizational skills 
  • Demonstrated ability to work independently as well as part of a multi-functional study team 
  • Able to motivate a team to work effectively under a changing environment 
  • Able to solve problems under pressure 
  • Self-motivated and able to work effectively in a matrix/team environment 
  • Availability for potential travel domestically and internationally 
  • Work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process. 
  • Advanced MS Excel skills a plus 
  • BS/RN degree or equivalent party assistance for this search. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

59) Senior Java Software Engineer – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) RF103P

DESCRIPTION:

  • Design and develop high performance components/sub-systems for a highly scalable service oriented NGS software
  • Assist in defining the appropriate data models, transformation technologies, and indexing/search algorithms for large-scale genomics data.
  • Use best practices and architectural rigor during the software design process, providing input on alternative strategies and solutions.
  • Write well-documented, extensible software code that is easy to maintain, and that adheres to generally accepted programming standards and OOP practices.
  • Own the overall quality of your code including unit testing, functional testing and performance.
  • Produce and maintain technical designs and documentation relevant to assigned software development tasks.

EXPERIENCE AND QUALIFICATIONS:

  • Highly proficient in JAVA and strong understanding of multi-threaded programming
  • Excellent grasp of OOP concepts and design patterns
  • Experience analyzing and defining requirements, and translating them into technical specifications and architecture
  • Knowledge of DBMS and database architecture and normalization
  • Expertise in one or more technologies like Lucene, Hadoop, Storm, No-SQL database
  • Knowledge of scalability/performance issues and optimization techniques
  • Experience with Web Services (such as Spring and RESTful)
  • Experience with source control and issue tracking systems as well as debugging tools
  • Strong problem solving, analytical and object-oriented programming skills
  • Excellent verbal and written communication skills, teamwork, and time management abilities
  • 5+ years of developing highly scalable, fault-tolerant, distributed backend services for web applications
  • Preferred Bachelor’s degree or equivalent experience in bioinformatics, or computer science with knowledge of Next Generation Sequencing technologies

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

60) QC Technician – Contract (New York) 4618R73

DESCRIPTION:

  • Perform various testing on incoming raw material and finished products and in process test samples as needed.
  • Enter data, review data to ensure the final release raw material or finished products and/or components in the applicable systems.
  • Follow and adhere to cGLP's, cGMP's, SOP's and all safety regulations as they apply to the laboratory and work areas.
  • Represent the laboratory on cross-departmental teams as needed.
  • Provide support where necessary to the functioning of the FPTL, Microbiology and Analytical Laboratories
  • May be required to perform other related duties as required and/or assigned.
  • Works in a laboratory. 
  • May be required to stand for long periods of time while performing duties. 
  • Must be able to work safely with chemicals, biologics and hazardous materials. 

EXPERIENCE AND QUALIFICATIONS:

  • Candidate must be able to work independently, as well as on teams within the Incoming Quality Control , Analytical Chemistry, Microbiology, Environmental, and Cell Culture laboratories. 
  • Must have the ability to multitask in a fast-paced environment and prioritize work as necessary. 
  • Required to work on tasks of moderate scope where analysis of situations or data requires problem-solving skills. 
  • Requires a full functional knowledge of laboratory equipment and techniques including Karl Fisher analysis. 
  • Excellent written and oral communication skills are required. 
  • Accuracy and attention to detail is required in performing all functions of this position. Initiative, organizational and computer skills are extremely valuable to ensure effective laboratory operations. 
  • Must demonstrate judgement, tact, and diplomacy in dealing with internal and external customers. 
  • Must be able to work in a team-oriented environment in order to support all daily functions of the lab. 
  • Must possess self-motivation and the ability to work on routine analysis with no instructions or new assignments with limited instructions. 
  • Candidate must have expert knowledge of Empower software for use on Analytical systems and Excel for reporting results.
  • Minimum of A.A.S. degree in Chemistry, Biology, Biochemistry or Environmental Sciences; preferred to have a Bachelor degree in Chemistry, Biology, Biochemistry, or Environmental Sciences; or equivalent experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

61) Administrative Assistant III – Contract (New Jersey) 6991

DESCRIPTION:

  • Provide administrative support to project team
  • Assist with scheduling workshops/meetings at multiple locations including arranging multi country video conferencing sessions
  • Organize training sessions, track training logistics and maintain completion records.
  • Maintain documentation in project repository
  • Onboard external contractors
  • Assist in domestic and international travel arrangements and expense report preparation
  • Support project team in printing and filing project documentation as needed
  • Order and maintain office supply inventory
  • Assist with AED/PO creation and tracking of project spend
  • Support the preparation of presentations/spreadsheets and meeting minutes
  • Maintain project team calendars
  • Project assistance, data entry and other project support requests as needed.

EXPERIENCE AND QUALIFICATIONS:


  • Strong writing and communication skills
  • Must have advanced knowledge of or ability to quickly learn internal electronic systems to facilitate completion of tasks (Sharepoint, Webex, Cliqbook/Concur, eRoom etc.)
  • Ability to work independently and to provide support to individuals in multiple locations
  • Excellent organization skills 
  • High attention to detail with a desire to get jobs completed in an accurate and timely manner
  • Minimum 5+ years of experience using computer technology including the Microsoft Suite of tools (Outlook, Excel, Powerpoint, Word and others)
  • High School Diploma and 5+ years administrative experience
  • Associates Degree and 5+  years of experience supporting multifunctional department & leaders a plus

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

62) Biostatistician – Contract (Massachusetts) 6455

DESCRIPTION:

  • Develop and maintain automated analysis and quality control pipelines for a variety of NGS applications such as DNA-seq, ChIP-seq, and RNA-seq.
  • Implement pipelines in HPC environment and track performance metrics.
  • Evaluate new and existing NGS tools using benchmark datasets, and design strategy for integration into existing pipelines.
  • Support integration of pipelines with LIMS systems.
  • Provide ad hoc analysis support and deliver results to project teams. Consult with project teams on their NGS analysis needs and develop analysis plans.

EXPERIENCE AND QUALIFICATIONS:

  • An ideal candidate will be collaborative, self-directed and possess
  • First-hand experience in NGS analysis tools and methods as well as the computing infrastructure and data management methods to support NGS analysis
  • Expertise in bioinformatics software and applications development and documentation
  • Proficient programming skills in Python, Perl, Java, C++, UNIX/Bash or equivalent with bioinformatics applications, experience in high performance computing environments (HPC) and version control systems (Git, CVS)
  • Experience at integrating publicly or commercially available genetic, genomic, and interaction datasets is a plus
  • Statistical programming skills like, SAS/S-plus, R/bioconductor and pipeline pilot or equivalents are a plus
  • A background in Molecular biology, Translational Research, Disease Biology or Quantitative Methods is a plus.
  • Positive, proactive can-do mindset
  • Demonstrated ability to lead projects of moderate scope, mapping-out critical path, milestones and timelines, as well as manage customer expectations with minimal supervision
  • Developed communication and presentation skills and a successful track record of collaborating with cross-functional scientific teams
  • B.S. or M.S. in Bioinformatics, Computer Science or related fields with a minimum of 3-years research (academia or industry) developing software for bioinformatics applications and analysis of sequencing data.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

63) Supply Chain Manager – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) T82BL

DESCRIPTION:

Overview:
Responsible for supporting all clinical supply chain activities. Primary duties will include but the oversight of clinical supply CMOs including packaging, labeling  and distribution of IP (investigational product), preparation of label texts and specifications, review of packaging specifications and distribution instructions, submitting and tracking  drug orders, coordinating with clinical operations staff, reviewing and processing temperature data, coordinating domestic and international shipments, tracking and maintaining inventories according to supply plans and study requirements, and document management.

The incumbent will work on a wide range of diverse to complex problems in which analysis of data and/or situations requires an in-depth evaluation of identifiable factors. This position will exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining solutions. 

Responsibilities:
  • Under minimal supervision, manage and execute against drug supply plans in support of clinical programs
  • Coordinate labeling packaging and shipment of packaged supplies: preparation and review of labels proofs and Specifications, preparation and review of Product Packaging Specifications, and preparation and review of Study Distribution Instructions and return Instructions.
  • Requires project management skills including time line generation, action tracking, meeting facilitation, effective communication skills and good documentation practices. 
  • Develop effective relationships with partners across a wide range of staff levels.
  • Develop effective relationships with internal and external partners in supply chain.
  • Assess issues with regards to study design, supply availability and timeline.
  • Promptly identify and escalate risks to study supply to all key stakeholders and internal management.
  • Represent GTO (Global Technical Operations) Clinical Supply Chain in cross-functional clinical study meetings 
  • Work closely with Clinical Supply Chain management to participate in the building and maintenance of clinical study supply plans:
  • Strategize with study managers and review study protocols to determine appropriate packaging configurations, blinding techniques, and optimal distribution plans.
  • Determine distribution strategies for clinical studies.
  • Participate in planning meetings to ensure that project needs, priorities and timing are understood.

EXPERIENCE AND QUALIFICATIONS:

  • Strong understanding of clinical trial design, execution and impact of IP (investigational product) supply. 
  • Proven experience working either in house or with clinical supply CMOs on the execution of packaging, labeling and distribution of IP. 
  • Strong knowledge and understanding of GMP and/or GCP
  • Experience or familiarity with IXRS and managing the forecasting planning of clinical drug supply needs considered a plus.
  • Self-directed with the proven ability to work autonomously.
  • Must possess the ability and desire for problem solving and decision making in a cross-functional team setting.
  • High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines. 
  • Solid interpersonal and communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company. 
  • Proficient in MS-Office (Excel, Word, PowerPoint, Outlook).  
  • Knowledge of Microsoft Visio and Project considered a plus.
  • Flexible, high level of integrity, action and goal-oriented. Balances process and theory with practical application and good judgment. Enjoys a fast-paced, team-oriented, and collaborative environment.
  • Bachelor of Science in life sciences is preferred. Work experience may be substituted for education. 
  • Minimum 4 years in life science industry related experience including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trails Coordination.
  • At least 2 years direct experience in clinical supplies environment
  • Experience in clinical trial supplies required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

64) Clinical / Scientific – Contract (San Francisco Bay Area) 73B4746

DESCRIPTION:

  • Perform design verification and analytical validation studies in the lab for IVD products.
  • Generate test protocols, review and analyze results, and generate V&V reports per FDA and ISO regulation.
  • Maintain proper ISO and FDA QSR documentation and implementation.
  • Support to transfer molecular IVD assays from R&D into manufacturing.

EXPERIENCE AND QUALIFICATIONS:

  • Understand IVD assay development process and PCR technologies.
  • Good knowledge in CE-IVD and PMA regulations especially for companion diagnostics applications.
  • Experience in IVD product development under design control.
  • Strong bioinformatics skill for data analysis and familiar with statistical analysis.  
  • Ability in writing qualified document and in oral presentation of data. 
  • Experience in maintenance of a IVD-regulated lab.
  • BS or MS in relevant scientific discipline
  • 3+ years experience in the IVD diagnostic industry

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

65) Packaging Engineer – Contract (Pennsylvania) 9838

DESCRIPTION:

  • Will be engaged in developing secondary and tertiary package designs for injectable products (vials and syringes).  The design activity will include cartons, labels, and shippers and include working with vendors to develop the supply of the components.  
  • The person will also be involved with shop floor activity in qualifying the designs on industrial packaging lines.   
  • Experience with the design process, qualification studies, and distribution qualification are required.

EXPERIENCE AND QUALIFICATIONS:

  • Candidates with Pharma or medical device packaging experience needed, food industry will not be considered
  • GMP experienced candidates preferred
  • Ideal candidate can write test protocols and execute, write/author documents, and work on multiple projects
  • Experienced in developing specifications for cartons, labels, and shippers
  • Experience in qualification of new components on industrial packaging lines
  • Experience with vendor relationships with packaging components
  • Familiar with packaging for injectable products (syringes, vials)
  • Familiar with distribution study design and execution
  • Prefer some experience with industrial packaging lines
  • Minimum 5 years experience in secondary package design, especially for glass containers
  • BS in Package Design Engineering or BS in Packaging Engineering strongly desired, however relevant BS plus relevant experience will be permitted.  

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

66) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) F128KZ

DESCRIPTION:

Overview: 
Ensure timely conduct of clinical studies according to protocols, Good Clinical Practice, Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Position reports to Associate Director, Clinical Operations.

Responsibilities:
  • In conjunction with Associate Director, coordinate activities of clinical trial sites.
  • Attend Site Qualification Visits to assess investigator’s staff and facilities.
  • Contribute to study design and initiate planning for global programs (Protocol Amendments and ICF template revisions; Case Report form design and review; Patient instruction cards, and other study materials).
  • Assist in the preparation and review of supportive study documents and study plans (Monitoring Plan, Lab Manuals, Project Plans, IWRS, CRF Guidelines).
  • Ensure all local regulatory approvals are in place for conduct of trial.
  • Conduct study initiation visits, including training of on-site personnel in all aspects of study requirements.
  • Conduct monitoring visits to the sites at intervals specified in monitoring plan.
  • Assist in auditing of clinical trial data for accuracy and consistency and arrange correction of errors as appropriate.
  • Identify, assess and implement appropriate activities to ensure trial progress.
  • Coordinate supplies for specimen collection and shipment of samples for assays.
  • Monitor supply of investigational and comparator drug supply throughout the trial.
  • Assist with product accountability at site and take appropriate action to resolve discrepancies.
  • Report adverse events per protocol and Standard Operating Procedures.
  • Conduct study close-out visits.
  • Document all trial information with adherence to applicable guidelines and Standard Operating Procedures.
  • Remain current with study data.
  • Maintain high level of familiarity with clinical literature of study area.

EXPERIENCE AND QUALIFICATIONS:

  • Preferred knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
  • Ability to work within a team.
  • Excellent communication and interpersonal skills.
  • Attention to detail and highly organized.
  • 25% travel.
  • BA/BS in Life Science or related discipline.
  • 2-5 years of experience in clinical study coordination.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

67) Regulatory Manager External Pharmaceutical Production – Contract (New Jersey) 9959

DESCRIPTION:

  • Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidances using ECC - a Documentum based electronic change control system.
  • Author and compile CMC dossiers for NDA supplements, annual reports, phase IV IND, and DMF (drug master file) annual updates for assigned drug products in eCTD (electronic common technical document) format using GRESDA - a Documentum based global document management and publishing system.
  • Work closely with quality, manufacturing, regulatory, and technical staff throughout company locations and external manufacturers to communicate, coordinate and track required documentation in support of post-approval CMC activities of the assigned drug products.
  • Interface with FDA as required in defining/negotiating filing requirements and/or responding to questions or information requests for CMC changes.
  • Utilizing proper dossier templates and TOC, import CMC documents for EPP-NA 3rd party products in DOMASYS system.
  • Assure the compliance of all FDA regulated post-approval activities including, but not limited to, timely and accurate submissions of NDA/DMF Annual Reports and supplemental applications for CMC changes for 3rd party products that affect local markets.
  • Provide Annual Reports (ARs), Change being Effected in 30 days (CBE30) and prior Approval Supplements (PAS) for local 3rd party products not covered by US-RMC.
  • Serve as Chairperson for monthly change control committee.
  • Performs other duties as requested including drug import/export support, international product registration, drug and medical device listing, and FDA establishment registration for 3rd party products that affect local markets.
  • Maintain current awareness of new and revised CMC regulations.
  • Provide interpretation of CMC regulations and FDA guidances to internal project team members and corporate partners when needed.
  • Demonstrates required competencies on a consistent basis.

EXPERIENCE AND QUALIFICATIONS:

  • Prior experience in FDA post-approval CMC changes submissions in CTD/ eCTD format for NDA/ ANDA.
  • Excellent oral and written communication skills in regulatory CMC documentation.
  • In-depth knowledge of U.S. Pharmacopeia (USP) and code of federal regulations (CFR) for food, drugs and cosmetics.
  • Excellent team work and negotiation skills in dealing with internal and external partners with the ability to lead and manage regulatory CMC projects.
  • Prior experience in interacting and negotiating with FDA Chemistry Review Staff desirable.
  • Prior experience in pharmaceutical laboratory, formulation, and/or manufacturing desirable.
  • Knowledge of French desirable to effectively interface with headquarters
  • Minimum BA/BS from an accredited school in a science/health field (eg, Chemistry, Pharmacy, Biology)
  • 7+ years industrial experience (chemical, analytical, pharmaceutical, manufacturing) including 5 years in Regulatory CMC

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

68) Regulatory Manager External Pharmaceutical Production – Contract (New Jersey) 9959

DESCRIPTION:

  • Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidances using ECC - a Documentum based electronic change control system.
  • Author and compile CMC dossiers for NDA supplements, annual reports, phase IV IND, and DMF (drug master file) annual updates for assigned drug products in eCTD (electronic common technical document) format using GRESDA - a Documentum based global document management and publishing system.
  • Work closely with quality, manufacturing, regulatory, and technical staff throughout company locations and external manufacturers to communicate, coordinate and track required documentation in support of post-approval CMC activities of the assigned drug products.
  • Interface with FDA as required in defining/negotiating filing requirements and/or responding to questions or information requests for CMC changes.
  • Utilizing proper dossier templates and TOC, import CMC documents for EPP-NA 3rd party products in DOMASYS system.
  • Assure the compliance of all FDA regulated post-approval activities including, but not limited to, timely and accurate submissions of NDA/DMF Annual Reports and supplemental applications for CMC changes for 3rd party products that affect local markets.
  • Provide Annual Reports (ARs), Change being Effected in 30 days (CBE30) and prior Approval Supplements (PAS) for local 3rd party products not covered by US-RMC.
  • Serve as Chairperson for monthly change control committee.
  • Performs other duties as requested including drug import/export support, international product registration, drug and medical device listing, and FDA establishment registration for 3rd party products that affect local markets.
  • Maintain current awareness of new and revised CMC regulations.
  • Provide interpretation of CMC regulations and FDA guidances to internal project team members and corporate partners when needed.
  • Demonstrates required competencies on a consistent basis.

EXPERIENCE AND QUALIFICATIONS:

  • Prior experience in FDA post-approval CMC changes submissions in CTD/ eCTD format for NDA/ ANDA.
  • Excellent oral and written communication skills in regulatory CMC documentation.
  • In-depth knowledge of U.S. Pharmacopeia (USP) and code of federal regulations (CFR) for food, drugs and cosmetics.
  • Excellent team work and negotiation skills in dealing with internal and external partners with the ability to lead and manage regulatory CMC projects.
  • Prior experience in interacting and negotiating with FDA Chemistry Review Staff desirable.
  • Prior experience in pharmaceutical laboratory, formulation, and/or manufacturing desirable.
  • Knowledge of French desirable to effectively interface with headquarters
  • Minimum BA/BS from an accredited school in a science/health field (eg, Chemistry, Pharmacy, Biology)
  • 7+ years industrial experience (chemical, analytical, pharmaceutical, manufacturing) including 5 years in Regulatory CMC

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

69) Publications Manager – Contract (New Jersey) 6735

DESCRIPTION:

  • Plan and execute medical projects and publications that support brand educational initiatives.  
  • Work collaboratively across various teams (Medical Affairs, Publications, Compliance, Legal, Statistical Operations, Finance, Planning & Operations)  to ensure projects are managed individually to suit the needs of the unique initiatives, monitor timelines , oversee budgets and certify SOP guidelines are adhered to.
  • Manage the budget(s) for assigned project(s) which require reviews on a monthly and quarterly basis, forecasting, gating, reconciliation and development of budgets for new initiatives.
  • Responsible for the management of Datavision and CLEAR for the tracking of all assigned publications (abstracts, posters, manuscripts, resubmissions) to ensure compliance with SOP. 
  • Coordination of internal schedules for TCs with agency, authors and vendors to ensure calls are scheduled in a timely fashion.
  • Follow up with both internal and external reviewers on overdue comments for publications/projects and develop tactics to secure comments in a timely manner.
  • Coordinating with internal staff and external experts for authorship suggestions and compiling lists of appropriate author candidates for subject manner.
  • Oversee the management of agency, outside statistical vendors and independent freelance writers. 
  • Interact with IST coordinators and medical liaisons for the management of IST publications through CLEAR.
  • Work with vendors to negotiate prices of projects

EXPERIENCE AND QUALIFICATIONS:

  • Strong Communication skills
  • Medical Publications experience
  • Project Management skills
  • Budget experience
  • BS

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

70) Engineering – Contract (San Francisco Bay Area) 4103B73

DESCRIPTION:

  • Design experiment and develop process verification/validation protocols in support of new product introductions as well as process improvements to sustaining product lines to ensure product quality going out to customers
  • Design experiment and develop qualification protocols in support of new or alternate raw material to strive for decreased cost of goods while ensuring product quality going out to customers
  • Oversee the execution of the protocols and carry out additional testing as needed; summarize results in a verification/validation/qualification report
  • Present technical data out to team as appropriate
  • Act as technical advisor to project team

EXPERIENCE AND QUALIFICATIONS:

  • Experience in process verification/validation and material qualification
  • Knowledgeable in Oligo Synthesis and Gene Synthesis a plus
  • Proficient in design of experiments, data analysis and ability to interpret and summarize results clearly, concisely, and accurately
  • Knowledgeable in Design for Six Sigma a plus
  • Excellent time management skills and ability to work independently
  • Solid technical writing and verbal skills
  • Good organizational skills and lab practices
  • Maintain lab notebooks and issue development reports (Process Verification and Validation, Gage R&R, etc.) as appropriate
  • Able to handle multiple projects at once
  • Good working knowledge of ISO 13485 and cGMP a plus
  • Experience with FDA regulated products a plus
  • BS or MS in chemical engineering, and 2 to 3 years industrial experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

71) Specialist, Quality Assurance – 6-12 Month Contract (San Francisco Bay Area) G94LT

DESCRIPTION:

SUMMARY:
Works on problems of diverse scope where the analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods, techniques for obtaining solutions.  Normally receives no instructions on routine work and general instructions on new assignments.  Works on assignments that are often highly complex in nature where judgment is required in resolving problems and making routine recommendations.

DUTIES:
  • Perform cGMP/cGLP audits of internal departments and external contractors.
  • Manage, evaluate, and approve Quality System documentation including deviations, CAPA’s, and planned changes.
  • Evaluate document changes for compliance requirements (SOPs, specifications, test methods, etc.).
  • Evaluate compliance of completed manufacturing documents (batch records forms, etc.) and completed QC documents (test results, analytical methods, and bills of testing, etc.) according to Production schedules.
  • Interact with Manufacturing, Fermentation Development, and Quality Control to continually improve compliance with quality systems, internal SOPs, and regulatory requirements and to resolve minor and major deviations.
  • Participate as required in investigatory teams to resolve major quality issues.
  • Participate in compliance audits of quality systems, manufacturing areas, vendor, QC, and support functions as required.
  • Prepare lot release packets in standardized format for upper management review and disposition.
  • Approve areas before use (line and room clearances).

EXPERIENCE AND QUALIFICATIONS:

  • Extensive knowledge of cGMP regulations as they may be applied in clinical biotechnology manufacturing.
  • Previous experience working in a cGLP regulated industry is a plus.
  • Bachelor's degree (B.A. or B.S.) from four-year college or university
  • 6-8 years related experience, 3+ years in Quality Assurance.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

72) Clinical Project Manager – Full Time Position (San Francisco Bay Area) Z104GN

DESCRIPTION:

  • Provide overall coordination and management of a clinical trial, in conjunction with the clinical team, and to serve as the primary contact with the sponsor and clinical team. 
  • Depending on the scope of work, this individual may be involved in some but not all of the functions.
  • Takes a lead role in a study or series of studies, and may provide strategic and tactical planning, organization, direction and tracking for completion of a study or series of studies within a project (including oversight of clinical project timelines, reports, budgets, monitoring, site management, clinical supplies and data collection)
  • Facilitate and foster positive and productive communication between sponsor, team and other functional groups. 
  • Develop and implement a project-specific communication plan, in agreement with the sponsor
  • Ensure timely and accurate communication of all aspects of the project to the team, including sponsor requirements, instructions and changes
  • Communicate with management on project progress, resource needs, sponsor issues, and team member performance
  • With Sponsor input, and based on project requirements, carry out project planning; document plans in writing for distribution to the team, sponsor and management, as appropriate. 
  • Monitor and update plans throughout the life of the project.
  • Quality parameters – identify SOPs, guidelines, templates to be used and provide to members.
  • Develop a plan and obtain sponsor approval before site visits occur;
  • Resource plan – with input from management, and other functional managers, assess how many, who, when and for how long; assess site assignment/workload by region. 
  • Monitor and adjust the resource plan based on project or team member changes
  • Develop contingency plan(s), with team and Sponsor input, for potential hurdles that would delay the project's progress
  • Assess training needs of team members on therapeutic area, protocol, special procedures/skills; develop training plan for new team members added later
  • Develop processes to support the team's activities (i.e. flow of site visit reports and other documents for review and submission, travel calendar, teleconference call-in process, etc.)
  • Identify detailed work activities and develop timelines with team and other functional group input and Sponsor approval (Excel, MSProject tools)
  • Monitor and manage the project's progress, identify hurdles and manage changes, via frequent interactions with team, other functional groups, and sponsor.
  • Schedule regular team meetings/teleconferences to track progress and status of activities and to obtain direction, changes, and decisions
  • Monitor, manage and adjust timelines and milestones with input from team, other functional groups and Sponsor; re-assess critical path and communicate to all
  • Track performance metrics of team
  • Provide informal and formal status reports to Sponsor, team, (and management, as required)
  • Track out-of-scope requests. 
  • Communicate with company and client regarding out-of-scope items
  • Monitor and adjust the resource plan based on project or team member changes
  • Manage study billing/budget versus proposed budget, as appropriate
  • Oversee activities and deliverables of outside vendors, as requested. Ensure communication occurs between outside vendors and others
  • Manage and motivate team members, and monitor and guide their progress.
  • Attend and/or present at Investigator meetings and/or monitor training workshops
  • Develop and/or review study documents (i.e. protocol, investigator brochure, ICF, CRFs, operations manual, study aids, site budget, etc.)
  • Assist members in problem-solving of study and site specific issues
  • Review CRA-generated documents (i.e. site visit reports, letters, telephone reports, as needed)
  • Carry out potential Investigator screening and selection
  • Carry out collection/review of site regulatory documentation

EXPERIENCE AND QUALIFICATIONS:

  • Outstanding interpersonal, oral and written communication skills
  • Proven effectiveness as a team leader
  • Prior experience successfully managing multifaceted studies from inception through implementation and completion.
  • Computer proficiency in Microsoft Word, Excel, and PowerPoint are required. 
  • Experience with MS Project a plus
  • Infectious Disease, phase 3 preferred
  • RN or BS degree in biological sciences or related field or equivalent combination of education and experience: 5+ years CRA experience or 3 years CRA experience and 3 years directly related experience in health care industry.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

73) Bioinformatics Quality Scientist - Medical Genetics – Full Time Position (San Francisco Bay Area) B103MJ

DESCRIPTION:

Develop scalable methods to assess the correctness and completeness of biomedical information and the accuracy and reliability of analytics and interpretations.  This is an excellent opportunity to be directly involved in developing technology, delivering a high-quality product, and making an impact on human healthcare. 

Duties/Responsibilities:
  • Work with product managers, biologists, and developers to clarify and refine requirements, use cases, and workflows of new and exciting product features. 
  • Ensure the features are scientifically valid, useful, and technically robust.
  • Think critically about the technology and develop methods for testing scientific quality. 
  • Write and maintain code that can find issues in clinical and genomic data, determine when analytics may be faulty, or when interpretations are unexpected or not well-supported.
  • Analyze and report defects found with tests and assess risk.  
  • Be a passionate voice of scientific product customers internally.  
  • Evaluate, prioritize, and escalate issues as necessary.
  • Work with biologists and data analysts to assure the quality of processes, tools, and models for developing, delivering and maintaining system
  • Perform end-to-end application testing including scientific evaluation of features.  
  • Provide expert scientific and analytic guidance for improvements.

EXPERIENCE AND QUALIFICATIONS:

  • Strong foundation in human molecular genetics, understanding of human disease genetics, and/or extensive experience in human disease genomics. Cancer genetics and/or genomics preferred.
  • Experience using literature and public databases to interpret genetic variants.
  • Proven ability to solve problems using programming skills, especially in Perl, Python, or Java.  3+ years experience or formal or advanced training preferred.
  • Excellent critical and analytical thinking with strong attention to detail.
  • Energetic and open-minded individual with excellent verbal and written communication skills.
  • Enthusiasm to learn new technologies, explore diverse content, and algorithms.
  • Familiarity with genomics resources, e.g. UCSC Genome Browser, NCBI’s Entrez Gene, dbSNP
  • Familiarity with content sources used for interpretation of human sequence variants, such as human disease mutation databases, e.g. OMIM, ClinVar, COSMIC.
  • Experience with database design and programming (e.g. SQL, Oracle).
  • Knowledge of one or more of the following: Information Extraction, ontology, semantic technology, Artificial Intelligence, Natural Language Processing, or expert systems.
  • Knowledge of software development best practices, quality controls, testing techniques.
  • Graduate degree (PhD-level preferred) in human or medical genetics, human disease biology or genomics (cancer preferred), or bioinformatics.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

74) Manager/Sr. Manager, Clinical Contracts and Outsourcing – Full Time Position (San Francisco Bay Area) RY111J

DESCRIPTION:

  • Partner with legal and finance to write, review, amend, negotiate and close contracts
  • Ensure contracts are fair, equitable and enforceable
  • Keep accurate records, meet report deadlines and document significant events
  • Build and develop strong relationships with vendors
  • Prepare RFP, RFI and contract templates
  • Develop and maintain vendor selection documentation and processes
  • Review contract obligations in conjunction with Project management and Clinical Operations staff
  • Notify vendors/partners/subcontractors formally where issues/special circumstances or breaches of contract have taken place
  • Assist and work with senior management on special projects
  • Monitor vendor progress and performance to ensure goods and services
  • Conform to the contract requirements
  • Authorize payments consistent with the contract terms
  • Resolve disputes in a timely manner
  • Prepare and conduct project kick-off meetings, including delivering detailed briefing to the project and accounting teams

EXPERIENCE AND QUALIFICATIONS:

  • Expertise in large, multi-site, clinical trials with multiple vendor types is required.
  • Experience working departments that have established processes in place.
  • Direct experience vetting and negotiating with vendors is a must.
  • Good understanding of the clinical process is important.
  • Budgeting experience
  • Demonstrated capability of managing multiple external vendors for multiple clinical trials simultaneously.
  • Demonstrated leadership qualities, and strong influencing skills.
  • Management experience would be a plus.
  • Knowledge of applicable regulatory and ICH guidance regarding clinical research and GCP.
  • Demonstrated ability to multi-task, prioritize, and independently solve problems in a rapidly changing environment.
  • A strategic thinker who can efficiently utilize company resources and expertise to extract optimal vendor performance.
  • A strong person with the interpersonal skills and credibility, both internally and externally, to successfully negotiate contracts
  • An excellent communicator, both written and verbal, with the ability to train and present data, complex protocol designs etc., and influence internal and external colleagues as required.
  • Excellent organizational skills and attention to detail.
  • An innovative, driven and effective person with a “can do” attitude.
  • A goal-oriented person who can plan for the long-term and execute stated objectives.
  • A flexible individual who can operate comfortably in a rapidly changing and sometimes ambiguous environment.
  • Minimum of a BS degree with clinical contracts experience, global experience a plus. 
  • Experience in clinical finance, business development, or clinical operations would also be considered.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

75) Project Coordinator – Contract (New Jersey) 8376

DESCRIPTION:

  • Supports Projects and Evidence Based Medicine in the development of new contracts and change orders including contract planning, preparation, follow-up and execution of contracts for services pertaining to all of EBM project and department work.
  • Works closely with EBM project owners, finance, legal and procurement departments and external 3rd party vendors and consultants.
  • Additional duties may include administrative support for EBM staff as warranted by project work.  This will include filling in forms, FedEx shipments, subscription renewals, ordering of supplies etc.
  • Monitor the quality of contracting and will maintain compliance of the contracting policies and procedures.

EXPERIENCE AND QUALIFICATIONS:

  • Sound knowledge of contracts, business theory principles and practices; proven capability to apply them as required
  • Capability to work well in teams and with a variety of internal customers (evidence based medicine, Finance, Legal)  and outside suppliers
  • Capability to manage multiple priorities, review, understand and organize complex documents and resolve issues creatively.
  • Good interpersonal communication skills, customer service oriented
  • Strong work ethic, detail oriented, performing tasks with a sense of urgency
  • Requires excellent verbal and written communications skills and high ethical standards.   
  • Evidence based medicine experience preferred
  • Experience in working within a global & multicultural organization
  • Strong proficiency in MS Office (Word, Excel, Outlook, and MS Explorer)
  • Associates degree or higher preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

76) Procurement / Contracts Specialist – Contract (New Jersey) 8287

DESCRIPTION:

  • Create and manage contract workspace contents and tasks in NEXTS including entering of pricing terms from sourcing events, selecting appropriate templates, following policies and procedures in determining the routing of contracts, facilitate the contract approval process and work with business owner to facilitate contract execution 
  • Monitors the progress of contracts through the contract process and all phases through contract completion 
  • Manage all contract publishing process including scanning retrieval and uploading of executed contracts into NEXTS and communicates PO reference number to internal and external customers 
  • Ensure compliance with several different local contract approval policies and spend management strategies; function as process path gatekeeper and reviews all contract requests against local Contract Approval Policies 
  • Maintain the accuracy and consistency of contract information 
  • Performs SOX controls (review Contract Approval Policy, Delegation of Authority of contract signatories and compliance with records retention policies), and support compliance
  • Obtain appropriate documentation for supplier set-up
  • Generate various reports and status updates as needed 
  • Liaison w/ business owner and suppliers for issue resolution
  • Deal with confidential information 
  • Assist/support buyers upon request for sourcing activities to perform RFP transactional tasks when appropriate including data entry , documentation support, and project close out activities

EXPERIENCE AND QUALIFICATIONS:

  • Understanding of contracts and business, legal & financial terms and conditions including business specific requirements (i.e. tax, language, government, etc.) 
  • Excellent understanding of Procure to Pay process including financial, accounts payables and procurement process and systems (SAP, Ariba)
  • Solves and works independently and with team to solve complex problems 
  • Ability to be work efficiently under pressure with little supervision, deliver high level of customer service and proven track record of following through with assignments meeting strict deadlines
  • Ability to adapt and drive change, begins new tasks, assumes responsibility and makes decisions in line with process assessment
  • Qualified candidate should possess excellent organizational skills and a systematic approach to work with care taken over detail and due regard to confidentiality 
  • Must possess efficient analytical skills; attention to detail, diligently follow up on many items that are simultaneously in various stages of completion 
  • Plans, prioritizes, organizes and completes work to meet established objectives
  • Ability to prioritize and manage multiple projects simultaneously 
  • Must a be a self-starter - have a high degree of personal initiative 
  • Strong interpersonal skills 
  • Flexible disposition, effectively demonstrates competencies 
  • Bachelors degree from an accredited four-year college or university

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

77) Manager/Senior Manager, Clinical Contracts – Full Time Position (San Francisco Bay Area) C111KP

DESCRIPTION:


  • Available to interact with management and internal clients.
  • Will be a member of the legal team, a tight-knit group of highly-motivated individuals in a positive, professional working environment. 
  • Assist attorneys and team members in the intake, drafting, negotiation and post-execution administration of non-disclosure, material transfer, clinical trial, vendor services, and other agreements. 
  • The successful incumbent must be a self-starter and comfortable working in a fast-paced environment with high volume production requirements, and meeting frequent tight deadlines under minimal supervision. 
  • Manage the process and workflow of contracts, assure compliance with existing agreements, and ensure the proper routing of documents for full execution by corporate officers and outside parties and perform other duties as assigned by attorneys and other team members. 
  • A clinical focus is strongly preferred although there will be overflow work in other business areas.
  • Prepare drafts of agreements and negotiations with outside parties
  • Gather and confirm facts necessary to initiate contract formation with Legal team and internal stakeholders
  • Generate initial contract drafts and prepare successive redlines
  • Perform initial review of contracts and comments from outside parties
  • Negotiation with outside parties
  • Prepare/format and finalize contracts for execution
  • Work with  Legal team to administer a document-tracking database, including data entry and the generation of summary reports on agreement status
  • Monitor contracts for compliance with company and department policies
  • Perform other tasks as assigned by legal team members

EXPERIENCE AND QUALIFICATIONS:

  • The ideal candidate would also have significant experience working on international clinical studies.
  • Familiarity with the clinical study process
  • Excellent communication skills, both written and verbal
  • Excellent organizational and analytical skills
  • Demonstrated proficiency with Microsoft Office applications (Word, Outlook, Excel, Access) and experience with contract management and database applications
  • Flexible team-player with ability to balance multiple projects and instructions often with competing deadlines
  • Creative, self-motivated, self-starter with strong organizational, prioritization and interpersonal skills
  • Excellent skills for negotiating complex contracts with outside parties.
  • BA/BS and relevant industry experience
  • Minimum of three years’ experience in the review, negotiation and administration of clinical contracts (biotech preferred)

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

78) Director/Senior Director Clinical Development & Medical Monitor – Full Time Position (San Francisco Bay Area) W82BR

DESCRIPTION:

Provide clinical oversight for one or more projects and will work with a cross functional team to plan, develop, design, implement and complete clinical development (Phase I to 3) trials.  This position will have accountability for medical monitoring, analysis, and reporting of studies.  These programs will involve interactions and developing strategic relationships with research and clinical experts as well as regulatory agencies.  Duties may include interaction with regulatory and other partners/stakeholders in completion and submission of investigational new drug(IND) applications. 
  • May be the project leader of one or more clinical staged project and may also provide oversight and leadership for drug safety and pharmacovigilence.
  • Responsible for establishing and maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Works on abstract problems across clinical programs of the business.  
  • Identifies and evaluates fundamental clinical issues across clinical programs through assessment of intangible variables.  
  • Provide medical monitoring for clinical stage programs and function as the clinical representative on the cross-functional project teams. 
  • Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents.
  • Review individual adverse experience reports for accuracy and clinical importance, and summarize their relationship to the study drug.  
  • Provide reports to FDA or other regulatory agencies summarizing adverse experiences in compliance with regulatory guidelines. 
  • Attend and present material, as requested, at meetings as well as external meetings, such as investigator meetings. 
  • Play a key role in growing the company’s relationship with Investigator sites and key leaders. 
  • At the senior director level position, may function as a project team leader on one or more clinical stage project team. 
  • Provide cross-functional leadership to ensure project deliverables are met.
  • Business travel is required.
  • Other duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • Biotechnology/pharmaceutical experience in all phases of clinical trial, including late stage development experience and management of phase 3 clinical trials is strongly preferred.
  • Must be willing and possess the expertise to work within multi-disciplinary team of peers and outside experts.
  • Experience with early clinical trials, data analysis and interpretation as an understanding of safety and pharmacovigilence principles is required.
  • Must be versed in clinical aspects of FDA regulations 
  • Successful track record of establishing relationships with important external constituents such as clinical and/or research experts, government agencies, regulatory bodies, and advocacy groups.
  • Must be highly motivated and have outstanding attention to detail, particularly in terms of medical monitoring. 
  • Working knowledge of multi-disciplinary functions involved in a drug development process, eg, clinical operations, biostatistics, regulatory, commercial, etc.
  • Highly effective in prioritizing tasks and goals to ensure activities are on time, on target, and within budget.
  • Excellent interpersonal, verbal and written communication and influencing skills.
  • Excellent clinical and scientific presentation skills 
  • Excellent negotiation, judgment and decision-making skills.
  • Effective working within a cross-functional team and highly collaborative.
  • Committed to developing drugs that will make a difference in the life of patients.
  • MD board certified Internist or Pediatrician.  
  • Immunology experience and/or board certification or board eligibility in infectious disease preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

79) Research Associate – Contract (~ 25 hr/wk for 6 mths or longer; San Francisco Bay Area) B999RT

DESCRIPTION:

  • Responsible for research and development in collaboration with others.
  • Normally receives minimal instructions on routine work, and detailed instructions on new assignments.
  • Works on problems of diverse scope w here analysis of data requires evaluation of identifiable factors
  • Exercises judgment within defined practices and policies to select appropriate action for obtaining solutions
  • Is aware of method basic development and limited with good, sound laboratory techniques
  • Effectively communicates questions and issues in meetings
  • Keeps accurate notebook records in accordance with SOP and cGMP requirements
  • Presents work summaries and contributes to the corrections and/or updates of existing written documents
  • Follow s GMP / SOP regulations
  • Informs supervisor and is able to correct simple problems with guidance
  • Maintains accountability for methods, procedures and results
  • Must be able to function in a fast-paced and dynamic environment

EXPERIENCE AND QUALIFICATIONS:

  • Must have experience running HPLC and know Chemstation; Excellent understanding of what chromatograms look like; Good analytical skills
  • Strong communication and technical writing skills
  • Demonstrates effective use of software like Word and Excel
  • Masters or Bachelor’s degree in Chemistry or related field, plus relevant experience one to three (1-3) years working for a pharmaceutical company
  • Background in Analytical Chemistry with applicability to routine testing 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

80) Director / Sr Director Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) Y111AE

DESCRIPTION:

  • Strategic planning of clinical development plans required for evaluating the efficacy and safety of investigational drugs and biologics.  
  • With the assistance of direct reports, management and oversight of Phase 2 trials, leading to Phase 3 trials. 
  • This position reports to the CMO and is a member of the executive staff
  • Supports evaluation of safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners
  • Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
  • Reports clinical study findings at professional meetings
  • Identify clinical indications appropriate for investigational drugs

EXPERIENCE AND QUALIFICATIONS:

  • At least 10 years of experience in drug development in the biotechnology or pharmaceutical industry; respiratory experience required.
  • Phase 2 and 3 drug development experience including knowledge of clinical trial design, data interpretation and analysis required
  • Excellent verbal and written communication skills
  • Strong interpersonal skills and ability to work effectively with project teams
  • Management experience
  • Medical Doctor degree, board certified

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

81) Software Engineer – Contract (Oregon) 2076A73

DESCRIPTION:

  • Work as a member of a product development team creating database software to support management of data produced by a research instrument. 
  • Duties include developing database software to implement schema, implementing connection to application software via API, and performing unit and integration testing.

EXPERIENCE AND QUALIFICATIONS:

  • C/C++; MySQL; PostgreSQL; 
  • Windows MFC 
  • Minimum 5 years experience developing database applications in a product development environment using controlled software development processes
  • BSCE, BSCS or equivalent technical degree minimum

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

82) Senior Medical Director, Drug Safety – Full Time Position (San Francisco Bay Area) MT114A

DESCRIPTION:

Support development programs and post-marketing safety program. Responsible for providing medical guidance, assessment and oversight of any PV/signal detection and risk management on products.  The individual will contribute to set strategies in monitoring and analysis of cumulative safety information in the context of the benefit-risk profile. He or she should be instrumental to effective drug safety crisis management. Responsible for serving as "right hand" for the VP, DSP by preparing analyses and delivering insights; developing presentations; and facilitating strategic meetings. 
Serve as product safety expert and perform surveillance lead responsibilities, including interpretation and evaluation of aggregate adverse event and product complaint data for signal detection, trend analysis, and issue investigations. Demonstrate comprehensive understanding of the safety profile for assigned compounds.   Provide safety strategic guidance to clinical science on safety monitoring.

Job Responsibilities:
  • Effective in building collaborative working relationships within the safety team, functional groups and departments (i.e., Clinical, Regulatory, Quality, Medical Affairs) and corporate partners. 
  • Support VP of Drug Safety Pharmacovigilance on strategic planning and cross functional team programs and departmental initiatives and goals.
  • Timely identification and management of emerging product risks and timely identification of emerging safety issues.
  • Identify important safety issues and analyze pharmacovigilance data for inclusion in reports. 
  • Guidance to safety scientists and safety physicians for aggregate reporting.   Professional knowledge of clinical medicine is essential to sort medical facts in problem analysis and decision analysis.  Initiate and lead clinical interpretation and evaluation of aggregate adverse event and product complaint data.  Lead safety teams or surveillance initiatives to facilitate product safety issues discussion.  
  • Supervise pharmacovigilance personnel (direct reports, consultants and interns), including mentoring, training, and creating an environment for individual growth through problem solving, decision-making, and self-directed learning.
  • Guides regulatory reporting including individual case safety reports (ICSRs), NDA and IND annual report summary statements, and periodic aggregate reports like Periodic Benefit-Risk Evaluation Reports (PBRERs) and Periodic Safety Update Reports (PSURs) *
  • Plans cumulative safety information analyses from company or external databases
  • Demonstrates good understanding of observational studies used in pharmacoepidemiology and ability to provide a sound critique of such studies.
  • Demonstrates proficiency in verbal and email communication, including Microsoft Excel, Word, and Power Point
  • Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
  • Able to work independently, establishing work priorities and direction
  • Chairs cross functional safety committee meetings (internal or with partner companies); able to present complex information clearly and drive team to effective discussion and resolution.
  • Ensures timely review of protocols, informed consents and other study related documents for multiple products and therapeutic areas
  • Participates on and may lead various cross-functional teams, involving interaction with staff within and external to safety department, to convey and acquire drug safety information internally and externally
  • Directs highly complex communications and ensures that all customers are fully informed and knowledgeable of project activities and their status
  • May conduct and provide oversight of audits/inspections of systems and procedures to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to findings relevant to functional area
  • May participate in budget planning and management

EXPERIENCE AND QUALIFICATIONS:

  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way. 
  • Leadership in biotech/pharmaceutical organization with direct reports.
  • Must have excellent writing and communication skills
  • Familiarity with common safety databases (e.g. Argus, ArisG) is required
  • Previous experience in scientific /medical writing is desired
  • Product launch experience is desired
  • Ability to read and analyze scientific and medical literature
  • Knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
  • Working knowledge of MedDRA dictionary
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Epidemiology background is a plus
  • Proficient with Windows:  MS Word, Excel, Power Point and ability to learn new programs as needed
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Must have excellent organizational and problem solving skills
  • Ability to work under pressure and meeting tight timelines
  • M.D., Pharm.D., or Ph.D.
  • Minimum of 7-10 years experience with pharmacovigilance or clinical drug safety including risk/benefit analysis and safety assessment

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

83) Drug Safety Scientist – Contract or Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) E114AX

DESCRIPTION:

Assists and supports the ongoing aggregate review and analysis of product safety for both pre and post-marketing data. Tasks include preparation and authoring of aggregate safety data including signaling analysis, DSUR, PSURs (Periodic Safety Update Reports), Annual Safety Reports, and reports to support internal/external data safety monitoring boards. Collate relevant clinical safety information for safety signal review as guided by the director or manager.  The Scientist will also support other applicable Pharmacovigilance Plans, EU Risk Management Plans, product recalls, and other safety surveillance activities. The Scientist will author and assist in signal evaluations and the management of responses to regulatory agencies related to the assigned product and support query of safety data under the guidance of manager / director.
 
Responsibilities:

  • Use medical background and experience to integrate case-related information including medical conditions, lab results and procedures and effectively identify risk factors
  • Develop and conduct, with supervisory guidance, certain aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
  • Extensive medical writing, editing, source document review, and data extraction/verification. 
  • Perform literature search and evaluation
  • Track events of special interest
  • Participate in internal pharmacovigilance committee meetings and joint safety meetings with licensing partners (activities include, but are not limited to, presentation of safety data and taking meeting minutes)
  • Assist in preparation of safety related sections and associated documentation for clinical and regulatory documents (including clinical study protocols, patient informed consent forms, clinical study final reports, IND annual reports, DSUR, PSUR, integrated summaries of safety, RMP and European clinical expert reports)
  • Assist in the creation/revision of department procedures and policies

EXPERIENCE AND QUALIFICATIONS:

  • Strong organizational, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Outstanding communication skills (verbal and written).
  • Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Previous Drug Safety/Pharmacovigilance experience of at least 2 years in a global environment.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environment as well as post marketing environment
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
  • Familiarity with common Safety databases (e.g., Arisg, AERS, Argu) necessary.
  • At a minimum, Bachelor’s level degree in life sciences, pharmacy, or nursing. RN, PharmD or PhD strongly preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

84) Associate Director/Director, Epidemiology – Full Time Position (San Francisco Bay Area) AR114F

DESCRIPTION:

Provide support with expertise in epidemiology, disease and drug registry, and risk management to drug safety and pharmacovigilance, medical affairs and clinical science teams that are developing investigational drugs or marketed products.  Duties include design and analysis of observational studies, registries and post-marketing surveillance and identification of opportunities for population-based disease understanding, safety signal detection, pharmacovigilance, and risk management activities. Interact directly with drug development, medical affairs and post-market program teams to provide deliverables, progress the program, and meet regulatory requirements.

Job Responsibilities:
  • Working as the epidemiology expert for epidemiology within DSP, the person in this position leads epidemiology project activities
  • Provides epidemiology expertise and experience for drug development and marketed products
  • Collaborates with development teams on clinical trial design, safety analysis plans, and the evaluation of safety signals
  • Collaborates with Medical Affairs on disease registries initiatives.  Advise on design of study to gather targeted disease state information and to address population based questions
  • Investigates safety issues related to development projects and marketed drugs
  • Evaluates databases of health insurance claims and/or electronic health/medical records for the feasibility of epidemiologic studies and/or safety surveillance in addressing questions related to drug safety, disease prevalence, risk, and drug utilization and improve company’s knowledge on advanced epidemiologic know how and methodologies.
  • Recommends study design solutions and works with internal or external stakeholders to conduct studies to address compound/drug- specific issues.
  • Collaborates with development teams on clinical trial design, safety analysis plans, and the evaluation of safety signals.
  • Contribute to risk management plans (including REMS) and direct responsibility for executing studies defined as plan deliverables (e.g., registries, drug utilization studies, other observational studies, post marketing safety requirements) and evaluating the effectiveness of the plans.
  • Interact with company management, internal and external key opinion leaders, and regulators as appropriate to successfully conduct epidemiology studies, signal detection and data mining, and risk management.
  • Maintain smooth communication and good relationship with the key stakeholders, Medical Affairs, and Regulatory Affairs to fulfill the needs of development program and the regulatory post-authorization requirements/commitments.

EXPERIENCE AND QUALIFICATIONS:

  • Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including US, ICH and EU regulations. 
  • Demonstrates effective leadership and management skills, including ability to lead and manage a multidisciplinary team of physicians and scientists (including line managers) and ability to navigate joint decisions with business partnerships.
  • Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Able to lead meetings, present orally and interact with external bodies
  • Able to work effectively and influence across cultures and functions
  • Proven problem-solving skills and able to work independently
  • Able to manage multiple projects simultaneously and has excellent time management skills
  • Astute observational and analytical skills with a sense of urgency
  • Creative and innovative thinking
  • Able to contribute to strategic decision-making and high-level thinking
  • MPH, PhD in Epidemiology, or Equivalent
  • At least 7 years experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including, 5 years epidemiology/pharmacovigilance experience.  
  • Management or team leadership experience essential.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

85) Systems Engineering Manager – Full Time Position (New York) B126XG

DESCRIPTION:

Summary: 
Experience in leading a team of highly skilled systems engineers on complex medical device designs from the conceptual phase through successful product launch. This involves leading the requirements development, systems level architecture design, and interface design definition by collaborating with cross-functional disciplines within the product development environment. His/her team will establish high level product requirements and systems architectures, and will collaborate with department function peers and Project Mangers to create integrated technical designs and project schedules, ensuring that mechanical, electrical, and software subsystems function reliably as one integrated system. Key accountabilities include maintaining the technical competencies of the system engineering team by providing mentoring, training, evaluation, and recruitment.
 
Responsibilities:
  • Facilitate architectural and design decisions to ensure on-time delivery of quality products, within cost, schedule, and performance constraints
  • Lead system engineering processes, in particular establishing design inputs and top down design using various system requirement methodologies
  • Drive hardware and firmware development through the product lifecycle within a stage/phase gate PDP, utilizing risk management techniques and automated requirements traceability tools
  • Ensure team translates market-driven requirements into technical specifications, and ultimately flows them down into lower level hardware and firmware requirement documents
  • Allocate the necessary resources and skill sets to projects ensuring technical, cost, quality, and schedule requirements are met. 
  • Manage resources to meet multiple project needs and objectives. 
  • Gain consensus, lead, influence, and ensure cross-discipline participation and feedback.
  • Work with Project Managers to create and maintain integrated program schedules using advanced scheduling tools and processes such as MS Project, Gantt charts, and WBS
  • Act as technical expert within the system engineering function, advising and coaching subordinates to resolve technical or operational problems
  • Set annual and ongoing goals and objectives for group members. 
  • Write and conduct annual appraisals for group members, actively assessing team’s needs and gaps.
  • Create metrics on tracking design efforts, resources, and effectiveness towards improving product development cycles and quality. Lead functional process and tool improvement initiatives by being early adopter of ideas. 
  • Foster creativity and innovation in design solutions.

EXPERIENCE AND QUALIFICATIONS:

  • Must have experience with digital x-ray equipment technology and imaging science
  • System architecture experience with hardware/software for either medical devices or electro-mechanical devices
  • Experience leading a team in the development of system level product requirements, including high-level system and specific sub-system architectures
  • Successful product lifecycle experience, from the conceptual stage through product launch and into post-launch support.
  • Working knowledge of stage/phase-gate product development process.
  • Able to effectively interface with all project disciplines including Research, Product Development, Service Manufacturing, Regulatory, Marketing, Quality
  • Broad technical experience including electrical, mechanical, and software engineering
  • Experience in the development of processes and procedures which integrate systems engineering and modern design methodologies and associated tools
  • Systematic approach to problem solving and issue resolution combined with good understanding of the relevant technologies and their practical applications
  • Ability to effectively interface with team members in remote locations. 
  • Willing to travel; domestic and international.
  • Develop the skills and abilities of the system engineering function. 
  • Define best-in-class functional processes, standards, and tools. 
  • Conduct ongoing performance benchmarking
  • Strong analytical, problem solving and negotiation skills
  • Self-starter and capable of working with minimal supervision. 
  • Ability to multi-task and provide expertise and leadership across multiple projects.
  • Good oral and written communication skills, especially technical writing
  • Successful product lifecycle experience 
  • Strong technical foundation in engineering design 
  • Strong system architecture, strong system/subsystem integration experience medical devices
  • Strong mix of ME, EE, and SW understanding 
  • Must have X-ray and medical Imaging experience.
  • Strong skills with system/subsystem integration.
  • Strong understanding of HW/SW of electro-mechanical devices.
  • BS or MS degree in Systems, Mechanical, Electrical, Biomedical, or Computer Science. 
  • Strong technical foundation in engineering design principles.
  • Minimum 10 years experience as a Systems Engineer in a regulated industry (i.e. medical, aeronautics, nuclear) developing complex electromechanical systems controlled by embedded/application software
  • Minimum 5 years functional management experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

86) Medical Director – Full Time Position (San Francisco Bay Area) R125FW

DESCRIPTION:

  • Serves as the Clinical Research representative on project teams to provide the clinical expertise and input for IND submissions.
  • Provides strategic and operational leadership to the direction, planning, execution and interpretation of clinical programs and data collection to meet corporate timelines.
  • Responsible for the medical input required to design, plan, initiate, monitor and complete clinical trials of a Phase 1b compound.  Some responsibility for a Phase 2 trial as well.
  • Responsible for writing protocols, Investigator Brochures, and regulatory documents.
  • Reviews individual clinical trial designs and protocols, and final clinical study reports.
  • Responsible for establishing communications with prominent clinical investigators; serve as the point person for Investigator meetings and Clinical Advisory Board meetings.
  • Oversees interactions with local and central institutional review boards.
  • Oversees the processing of serious adverse events and approves coding activities.
  • Generates safety reports including annual reports for regulatory submission.
  • Oversees interactions with study sites.
  • Provides input on clinical sections in regulatory submissions, responses to FDA requests and pre-meeting packages.
  • Collaborates in planning for meetings with FDA

EXPERIENCE AND QUALIFICATIONS:

  • Good knowledge of FDA, GCP, GLP, and ICH guidelines/regulations.  
  • Specialty training in internal medicine; subspecialty training in rheumatology or inflammation related diseases a plus.
  • Strong medical/scientific written and verbal communication/presentation skills and investigative techniques.   
  • Strong problem solving skills, exceptional interpersonal skills with demonstrated successful team participation and management of clinical staff.
  • Experience supervising Clinical Trial Manager(s).
  • 5-10 years of relevant clinical experience in the biotech/pharmaceutical industry, with at least 5 years experience in drug development/medical affairs.  
  • Regulatory authority interaction experience a plus.  
  • Experience managing CROs a plus.
  • A Bachelors degree in a relevant scientific discipline and an MD.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

87) Sr. Product Manager – Full Time Position (San Francisco Bay Area) P73AG

DESCRIPTION:

Detailed Description

The objective of this position is to develop and manage portfolio of software products and services that provide value added growth for the business segment. This person will develop business cases and own all product management responsibilities for a growing portfolio of software products and services. This person will develop and manage a portfolio of on-market and new software products and services. Will be responsible for development of product definition, positioning, pricing and product lifecycle management. Responsibilities include developing market research, leading product management function in new product development teams, managing inventory, pricing, customer communications, support, and revenue forecasts. This position will manage transitioning of products from standalone desktop software to browser based products along with licensing and commercialization models and will manage maintenance and support plans. This position reports to the Director of IT Solutions Product Management in the Applied Sciences Business Unit.
 
Essential Functions
  • Manage worldwide supply, demand, revenue, margin and pricing for product portfolio; update and present forecasts regularly to management, finance, and manufacturing teams. 
  • Analyze market trends, customer requirements and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation. 
  • Lead new product development process from concept through commercialization, including voice of customer research, definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support and sales. 
  • Will lead business aspects of both internally-developed products, as well as those leveraged from external collaborations. 
  • Furthermore, our solutions should represent the best thinking of the pioneers of adjacent industries.
  • Will be a strong leader within cross-functional teams developing the right product to fill market needs, and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates. 
  • Will partner closely with the Instrument/Reagent Product Managers and Technical Marketing Specialists to ensure system synergies and optimal customer experiences. 
  • The software strategy will be developed and executed in concert with the centrally managed CIO office- ensuring best practices from one division are shared across all operating groups.
  • Desired applicants should bring specific experiences in building software development communities, designing software and building scalable architectures as well as SDKs. 
  • Some knowledge of Biological sciences and/or genomics is desirable, but not required. An aptitude and interest in learning science including bioinformatics is important. 
  • Candidate must possess a track record of success in driving business innovation, product development, building/leading cross functional teams and effective executive level communication.

EXPERIENCE AND QUALIFICATIONS:

  • Implement business strategy for software, including software as a product or a service
  • Lead product definition teams, defining critical product requirement documents with prioritized features and corresponding business or financial justification with ROI.
  • Understand, follow and be accountable for business aspects of Product Commercialization Process (PCP) for products
  • Assess and evaluate competitive landscape
  • Monetize software through direct and indirect economic business models, segregating differentiated value propositions for customer segments
  • Accurate market analysis, value proposition and forecasting and write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups.
  • Set pricing to meet revenue and profitability goals
  • Develop customer oriented sales tools and collateral in partnership with manage total product lifecycle, setting organizational cadence for retirement, refresh or enhancement of existing products- in concert with software engineering organization
  • Contribute globally to the company’s office as part of larger stakeholder community
  • Develop a thorough knowledge of target  customer segments, markets and the competition 
  • Contribute to overarching IT solutions strategy and roadmap

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

88) Principle Investigator – Contract (Pennsylvania) 8095

DESCRIPTION:

  • To be a principal investigator and a technical writer.  
  • Acquiring all of the information in order to write an informative summary (cause, effect and solution).

EXPERIENCE AND QUALIFICATIONS:

  • Former FDA experience is desirable
  • Technical writing skills.  
  • Strong root cause analysis skills with cGMP experience.  
  • To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
  • College preferred.  High school equivalent with experience accepted.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

89) Head of Project Management – Full Time Position (San Francisco Bay Area) R121MT

DESCRIPTION:

The position requires a seasoned hands-on professional to ensure that timelines are met, issues anticipated, resources are allocated and product development planning is maximized through an interdisciplinary team. In the near term, the position will act as the Project Director and Project Management lead for key programs, and then eventually will create a project management organization to oversee multiple programs.
  • Responsible for product portfolio and project planning process for the organization. This includes implementing portfolio management strategies and technology assessment processes and overseeing project planning methods for preclinical through clinical programs to launch or partnering milestones. The project management and planning includes return on capital analysis, risk profile and resource requirements, and is integral for the corporation’s annual operating and budget plan. The position is key to determine and oversee timeline management and risk analysis in order to meet corporate objectives. This position will lead the effort for continuous improvement of project operations, direct the operational aspects of the organization’s pharmaceutical partnerships, and direct programs and maximize resources through project management best practices.
  • Will report to CEO and will work closely with the executive team, functional leaders and program team representatives to achieve results in a matrix environment, and will be responsible for managing and influencing internally and externally to achieve project objectives on time and on budget.
  • Implement project management infrastructure, in addition to initially managing the day-to-day operations of the project teams and driving the deliverables.
  • Develop timelines, performance objectives, deliverables and meeting protocols for all project teams.
  • Participate in senior management and executive committee meetings to align corporate objectives with project team activities and deliverables.
  • Identify and solve resource allocation, product development risk areas and financial budget responsibilities and variances.
  • Anticipate potential issues and roadblocks to achievement of objectives; strategize and implement solutions.
  • Create dashboard and project team timeline snapshots for senior management updates.
  • Be a spokesperson for product development, portfolio planning and project management teams.
  • Be the senior operational contact for all partnered programs. 
  • Responsible for making decisions regarding the appropriate risk when there is substantial program impact.
  • Recommends, implements, and manages the appropriate program structure and standard performance metrics.
  • Contributes to the creation and maintenance of historical databases for the purpose of tracking, trending, learning, and improving decisions regarding program performance and continuance. 
  • Maximizes business results through continuous improvement in organization's ability to execute programs from initiation to completion and production scale.
  • Leads development team in defining program strategies and developing goals for the budget process.

EXPERIENCE AND QUALIFICATIONS:


  • Experience as a VP or Head of project management, or a candidate who has clearly demonstrated those skills. 
  • Extensive product development expertise and understanding of all stages of drug development; biologics drug development experience preferred.
  • Functional expertise outside of Project Management (i.e. Clinical, Finance, R&D, Operations).
  • Outstanding analytical abilities to review financial and project data and resolve project issues.
  • Excellent written and oral communication.
  • Strong interpersonal skills, conflict management skills, and influencing skills.
  • Facilitation, presentation, problem-solving, and conflict resolution skills.
  • The ability to interact with, and influence senior internal and external stakeholders.
  • Senior leadership experience with strategic planning, relationship management, and change management skills to collaborate and influence at all levels within the organization.
  • BS/MS or PhD in relevant scientific field, or MBA.
  • 15+ years experience in pharmaceutical/biotech industry, with proven track record of success.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

90) Associate Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) RT111D

DESCRIPTION:

  • Supports the planning and implementation of clinical development plans required for evaluating the efficacy and safety of investigational drugs and biologics.  
  • This position will support the medical monitoring activities and assist Sr. Director, MD, Clinical Development, in the management and oversight of Phase II trials, leading to Phase III trials. 
  • The therapeutic areas of interest include respiratory and oncology.  
  • This position reports to Sr. Director, MD, Clinical Development.
  • Supports medical monitoring efforts in Phase II trials
  • Supports strategic clinical trial input to the clinical operations team
  • Supports investigator selection and evaluations
  • Supports evaluation of safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners
  • Supports writing efforts on clinical study reports
  • Reports status of clinical programs to project teams and management
  • Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
  • Reports clinical study findings at professional meetings
  • Assists project teams to identify clinical indications appropriate for investigational drugs

EXPERIENCE AND QUALIFICATIONS:

  • At least two years of experience in drug development in the biotechnology or pharmaceutical industry; respiratory experience desired, but not required.
  • Knowledge of clinical trial design, data interpretation and analysis
  • Ability to analyze, interpret, and report clinical trial findings
  • Effective oral and written communication skills
  • Strong interpersonal skills and ability to work effectively with project teams
  • Medical Doctor degree, board certified

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

91) Manager, Drug Safety Science – Full Time Position (San Francisco Bay Area) F114JX

DESCRIPTION:

  • Identify and assist in the management of safety concerns with drug product(s).  
  • Ensure that any safety signals are appropriately evaluated, communicated and managed with guidance from supervisor.  
  • Responsible for writing documents required for assessment & communication of product safety information for core safety documents.   
  • Perform aggregate safety data tabulation and listing compilation.  Able to provide some clinical judgment on safety data review
  • Collaborate with safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible trends or concerns  
  • Contribute to development & maintenance of product safety profile
  • Track events of special interest and assist in development & maintenance of standardized queries for events of special interest
  • Support  the analysis in support of response to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
  • Draft regulatory inquiry responses
  • Provide input and review to key regulatory or clinical documents (i.e. clinical study reports, investigator brochures, integrated summaries of safety, DSUR); may author certain sections as needed under the supervision of the director
  • Perform literature search and review and able to effective determine appropriate and relevant literature for the purpose of safety analysis.
  • Participate in internal pharmacovigilance committee meetings as well as joint safety meetings with licensing partners

EXPERIENCE AND QUALIFICATIONS:


  • Previous experience in scientific /medical writing required
  • Ability to read and collate scientific and medical literature
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments
  • Working knowledge of MedDRA dictionary
  • Familiarity with common safety databases (e.g. Argus, Aris) is preferred
  • Proficient with Windows: MS Word, Excel, PowerPoint and ability to learn new programs as needed
  • Must have excellent writing and communication skills
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • MSc, Pharm.D., Ph.D. preferred
  • Minimum of 3 years experience with pharmacovigilance or clinical safety

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

92) Manager / Senior Manager, Drug Safety – Full Time Position (San Francisco Bay Area) H114FZ

DESCRIPTION:

  • Accountable for the day-to-day management and performance of case management team activities. 
  • Responsible for managing all aspects of safety operations by ensuring the accurate and timely collection, recording, evaluation and reporting of adverse events involving clinical trial and post-marketing studies. 
  • implements department policies and operating procedures. Develops systems, tools and processes for drug safety operations. Reviews and approves adverse event analyses and reports prepared by staff for submission to regulatory agencies. Collaborates with clinical teams, regulatory teams, clinical research organizations and corporate partners in the development of safety reporting procedures and post marketing activities. Sets project goals, timelines and resource requirements.  Maintain efficiency of the case management activities. 
  • Ensure that all Safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements (of all relevant countries), alliance agreements, and OPs and procedures.
  • Perform, or provide oversight for, all case processing activities including data entry, narrative writing, quality control, and coding of all cases to ensure accuracy, integrity and completeness of information entered in the Safety database.
  • Oversee the set-up of new Safety projects, including updating Safety Management Plans, and development and set-up of study specific Safety systems and processes (as needed).
  • Manage vendor safety reporting activities including site queries, extraction of eCRF information, and quality assurance.
  • Lead, or participate in, safety data analysis and/or procedure development projects to support the Clinical Drug Safety Science group. Participate in the planning and preparation of the adverse event and/or risk sections of protocols, IBs, and ICFs for  studies and review of CRFs (as necessary).
  • Support the Clinical Operation teams with respect to safety related issues as required.
  • Participate in Clinical meetings representing safety.
  • Oversee reconciliation of Safety database with clinical database for a given study.
  • Provide expert guidance on regulations and their impact on safety management processes and procedures.
  • Participate in the development and management of Data Monitoring Committees, including development of charters and ensure that activities/listings for meetings are completed in a timely manner and meeting outcomes are documented as needed for requests from IRBs/IECs and/or regulatory authorities.
  • Develop, manage, and implement departmental safety policies and SOPs.
  • Manage drug safety staff members, as applicable.
  • Performs other duties as requested.

EXPERIENCE AND QUALIFICATIONS:

  • Previous Safety/Pharmacovigilance experience of at least 5 years in a global environment.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
  • Familiarity with common safety databases (e.g., Arisg, AERS, Argus, etc.) a must.
  • Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Outstanding communication skills (verbal and written).
  • Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Education Requirements (degree, certifications, etc.):
  • At a minimum, Bachelor’s level degree in life sciences, pharmacy, nursing or RN. Master’s Degree or PharmD preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

93) Director, Drug Safety & Pharmacovigilance – Full Time Position (San Francisco Bay Area) GB114A

DESCRIPTION:

  • Responsible for the medical oversight of global pharmacovigilance activities of clinical trials and product development. Post-marketing safety experience is highly desirable.
  • Support Safety Operations to establish and maintain policies and procedures for the Clinical Drug Safety Department. 
  • Perform or provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
  • Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses.
  • Ensure ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management
  • Support both Clinical Science and Clinical Operations teams with respect to safety related issues as required
  • Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities. 
  • Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB, and other documents, as needed.
  • Oversee the activities of both internal safety meetings and external safety meetings with licensing partners (i.e. Joint Safety Management Team meetings). 
  • Collaborate with pharmacovigilance and drug safety colleagues from licensing partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.
  • Support development and maintenance of product benefit-risk profile
  • Manage Drug Safety Science staff members, as applicable.

EXPERIENCE AND QUALIFICATIONS:

  • General knowledge of pharmaceutical development and a minimum of 5 - 7 years of experience in Safety/Pharmacovigilance in a global environment.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed. 
  • Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) Argus experience preferred.
  • Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
  • Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Outstanding communication skills (verbal and written).
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • M.D.  required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

94) Medical Director – Full Time Position (San Francisco Bay Area) B114TN

DESCRIPTION:

Develops the strategies, designs, implements, monitors and evaluates clinical trials and other associated clinical development programs for assigned molecules or drugs. Medical Director will be assigned responsibilities for Ph II and Ph III clinical trials, programs and/or other projects.  Work closely with internal cross-functional stakeholders, external investigators, various corporate partners and regulatory authorities.

  • Plays a lead role in providing clinical input into the assigned therapeutic areas(s) scientific strategy. Helps Research and to ensure consistency of scientific and development strategies with target label claims and corporate goals. May be called upon to perform clinical assessments on relevant drug discovery projects
  • May also consult to Business Development on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic area(s) product pipeline and portfolio
  • Is responsible for creating the clinical development plan for assigned molecules, drugs and/or other programs
  • Regularly called upon to act as an internal consultant to various internal partners, stakeholders, teams and review or decision-making committees; providing clinical development expertise in relation to assigned therapeutic area(s)
  • Develops and delivers key presentations, both internally and externally, to convey the clinical development perspective and provide updates on activities.  Includes playing a key role in the organization and delivery of successful expert advisory boards
  • Participates in FDA or other health authority interactions with little or no supervision from his/her manager
  • Works with Regulatory and other partners/stakeholders in the completion and submission of IND (investigational new drug) applications and filings.  Supports Regulatory Affairs on clinical development aspects of filings; plays a central role in developing language in a drug’s Package Insert.  Acts as the clinical lead on Filing Teams.  Monitors IND filings for all assigned molecules and programs
  • Provides clinical oversight for a variety of projects:
  • Works with a host of internal and external partners and stakeholders in the design and implementation of clinical trials for assigned molecules and drugs
  • Designs and develops trial protocols; including effectively incorporating cross-functional strategies and input into programs
  • Develops the product safety profile
  • Gains alignment with various internal partners and stakeholders on goals and resource needs.  Includes working with core team project teams to establish appropriate budgets and other resource plans
  • Develops key clinical sections of Investigator brochures
  • Plays a key role in the identification of appropriate external investigators
  • Produces clinical components of presentations at clinical trial investigator meetings; delivering high-quality presentations at such meetings
  • Converts clinical development plans into project implementation plans and leads clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators, Clinical Operations and others internally and externally.  Measures project progress, monitors variances and is expected to proactively identify any issues or challenges and develop, recommend and implement strategies to effectively resolve such
  • Plays an important role in the development of disease and/or treatment registries.  Includes developing strategies or plans to enable appropriate registry recruitment
  • Keeps all partners abreast of developments throughout all applicable intervals
  • Contributes to safety and/or other relevant sections of IND annual reports, as these sections and reports relate to assigned molecules and/or drugs
  • May interact with Board of Directors and Investor Relations
  • Works closely with Clinical Operations to  close-out clinical trials and complete internal reporting of  trial status and results; including associated publications


EXPERIENCE AND QUALIFICATIONS:

  • Boarded in hematology or oncology
  • Biotech/pharmaceutical industry experience preferred OR be a recognized expert in the field
  • Strong background/experience with clinical trials (as typically measured by 2 or more years’ experience)
  • Strong, relevant therapeutic experience (as typically measured by 3 or more years’ relevant clinical experience)
  • In-depth understanding and firsthand knowledge of Phase I-III drug development.  
  • Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Demonstrate ever-increasing competence and abilities in leading disease strategy planning and reviews.  
  • Expected to provide important, strategic inputs in Clinical Development decision-making
  • Create targeted and executable clinical development plans for multiple molecules and or drugs
  • Deliver multiple projects and programs on-time, on-target and within-budget
  • Develop and cultivate important relationships with internal and external partners and stakeholders.  Includes developing and cultivating important relationships with thought leaders and KOLs (key opinion leaders)
  • Competently and collaboratively interact with a host of internal and external partners and stakeholders
  • Effectively represent Clinical Science on multi-disciplinary teams.  
  • Stay informed and abreast of the external landscape as it relates to assigned molecules,  drugs and/or programs and the associated therapeutic area(s)
  • Comprehensive understanding of product and safety profiles
  • Well-versed in medical aspects of FDA regulations 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

95) Professional Discovery Research – Contract (Massachusetts) 8555

DESCRIPTION:

  • Perform in vitro and in vivo assays to contribute towards the discovery and preclinical evaluation of immunotherapeutics and vaccines targeted against diseases   
  • Responsible for performing, documenting and analyzing data generated from experiments designed to characterize immune response elicited to vaccination, characterize antibodies, and study pathogenesis of bacterial targets.
  • Performs ELISA, ELISpot, SDS-PAGE, Western blot, flow cytometry and cell-based assays to evaluate immune response against vaccines and/or characterize antibodies.
  • Use microbiological techniques to evaluate the virulence and pathogenicity of infectious agents.  
  • Maintains and generates bacterial stocks to support preclinical models.
  • Performs in vivo experimental procedures aimed at establishing safety, immunogenicity and efficacy in preclinical models. 
  • Safely handle BSL2 class agents.
  • Document work in lab notebooks and perform laboratory support activities such as maintaining equipment and ordering lab supplies;
  • Summarizes and reports results to the supervisor
  • Perform other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Hands-on experience in performing ELISA, cell-based assays and microbiological techniques is required.
  • Experience handling small laboratory animals is required.
  • Experience handling BSL2 bacterial agents and culturing anaerobic bacteria is preferred.
  • Excellent attention to detail and reliability are essential.
  • Ability to work as a team member, to follow directions effectively and to manage multiple tasks is required. Once trained on the procedures should be able to exercise judgment and be able to plan, execute experiments and analyze obtained results.
  • Experience with Microsoft Excel, Softmax Pro and GraphPad Prism or other statistical analysis software is a plus.
  • B.S. degree in Biochemistry, Immunology, Microbiology, or related field with minimum two years experience in vaccine or biopharmaceutical industry.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

96) SCRA to Clinical Trial Manager – Contract or Full Time (San Francisco Bay Area) R82BW

DESCRIPTION:

  • Independently lead clinical trial project execution to ensure that trial timelines, costs, and quality metrics are met for a Phase 1 oncology trial
  • Serves as primary contact for functional area representatives in managing the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
  • Oversight for forecasting of clinical supplies
  • Manage study milestones to ensure accurate tracking and reporting of study metrics.
  • Manage trial-specific collaborations with other research entities.
  • Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
  • Create and manage clinical trial budgets and staffing/resourcing plans.
  • Provide study-specific direction and mentoring to CRAs, COCs, and support staff as appropriate. 
  • Manage adherence to ICH/GCP/local regulations.
  • Participate in clinical operations initiatives and programs as assigned and other duties as assigned.
  • Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Broad and current knowledge of regulations, clinical development process and therapeutic area to study plans.
  • Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met.
  • Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate.
  • Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
  • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
  • Excellent organizational and negotiation skills.  
  • Proven ability in creative problem-solving and possess sound judgment.
  • Team oriented and collaborates effectively with the clinical operations study team, cross-functional team members, and external partners.
  • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook.
  • Working knowledge of MSProject for development and update of clinical study timelines.
  • Willing to travel – anticipate 25%.
  • Bachelor’s Degree with 8+ years of clinical research experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

97) Sr Director / Director Clinical Operations – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R117GX

DESCRIPTION:

  • Lead functional work process optimization, continuous improvement, and change management in partnership with Clinical Operations leadership team colleagues [Study Management, Site Contracting, and Clinical Monitoring] for global clinical oncology trials.
  • Line management of CT Manager(s),Clinical Trial Associates (CTAs) , and other functional members as needed
  • Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues.
  • Ensure that employees complete assigned project tasks on schedule and meet/exceed the expectations of that project.
  • Performance management: Tasks include and are not limited to: setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports. Identify and address performance issues and training needs.
  • Lead interviewing, hiring, training, mentoring, and personnel development activities within area of functional responsibility.
  • Interact with study teams to ensure consistent functional performance and quality of work.
  • Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables.
  • Lead strategic planning and process development/ implementation for the function(s), tracking timelines to remain on schedule, and developing contingency strategies, if needed.
  • Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials.
  • Lead/participate in meetings to plan and implement cross-functional operational activities to increase quality, productivity, and efficiency within Clinical Operations.
  • Ensure effective and efficient collaboration between internal customers and external providers (CROs). 
  • Liaise with internal (Study Management, site contracting, Central Services) and external (investigational sites and vendors) partners/stakeholders to assess functional team processes/performance and opportunities for development/enhancement.
  • Collaborate and work effectively with other functional managers to establish high quality and efficient processes and ensure consistency and alignment throughout the team.
  • Maintain clear lines of communication with functional managers to ensure high quality deliverables are met.

EXPERIENCE AND QUALIFICATIONS:

  • Phase 3 experience required
  • Oncology experience strongly preferred
  • Line management and experience required
  • Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must.  Leadership skills.
  • Ability to foster a collaborative team environment, motivate others, work in teams in a matrix environment and with various levels both within company and with vendors as appropriate.
  • Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work effectively in a fast paced matrix environment.
  • Demonstrated competency in leading cross-functional process improvement efforts.
  • Demonstrated leadership and management skills, prior supervisory experience with demonstrated success in managing people, and expertise in mentoring and coaching.
  • Financial budgeting and resourcing planning skills.
  • Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. 
  • Knowledge of medical terminology.
  • Strong computer skills to include MS Office: Word, Excel and PowerPoint. 
  • Excellent oral/written/presentation – communication skills.
  • Cross-functional and cross-cultural awareness
  • BA/BS or equivalent degree in life sciences or allied health field.
  • Minimum of 10 years experience in clinical operations roles, including at least 3 years of global clinical trial experience. Oncology indication experience required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

98) Sr. QA Associate/QA Manager – Full Time Position (San Francisco Bay Area) G104XB

DESCRIPTION:

Provide consultation in the interpretation of GCP regulations, guidelines, policies, and procedures to staff; plan, conduct, and report independent Good Clinical Practice (GCP) Quality Assurance (QA) audits of internal systems/procedures and vendors against applicable regulations and procedures; support, maintain, review QA systems – Controlled Documentation System, Corporate Training program, and Corrective Action and Preventative Actions (CAPAs); and support/provide management with quality metrics and updates.
 
Responsibilities:
  • Manage the QA Document Control system.
  • Assist in SOP writing and/or review.
  • Assist in preparing and hosting Client audits 
  • Write/review/track CAPAs for audits.
  • Conduct audits (internal systems and vendor) 
  • Provide QA/compliance advice to staff.
  • Perform other related duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Strong knowledge of FDA GCP and ICH regulations, guidelines, and standards governing regulated clinical research is required.
  • Working knowledge and understanding of drug development and global clinical regulatory environment.
  • Outstanding interpersonal, oral and written communication skills.
  • Detail oriented.
  • Available to travel 10% of the time.
  • Bachelor's degree in scientific or related discipline, or equivalent work experience.
  • Minimum of 5-7 years industry experience, with at least 3-5 years in clinical QA.
  • Direct experience with internal/external clinical systems and process audits.
  • Experience in QA audits of Clinical Investigators and Clinical Vendors.
  • Experience in development of SOPs.
  • Strong software and computer skills; including MS Word, Excel, PowerPoint, and Outlook. Excellent presentation skills.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

99) Senior SCRA to Clinical Program Manager Level – Full Time Position (San Francisco Bay Area) W111HL

DESCRIPTION:

  • Reports to Sr. Director Clinical Operations; position initially has no direct reports but may within a year
  • Manage Phase 2A to 2/3 oncology program including CRO’s and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
  • Works closely and independently with the CMO and Medical Directors and represents clinical operations for this program

EXPERIENCE AND QUALIFICATIONS:


  • Experience in Oncology required
  • Must be hands on and used to a start-up environment
  • Knowledge of GCP and ICH guidelines required
  • Proficiency in the implementation, monitoring, and management of clinical trials
  • Able to work collegially within a team and carry out duties/responsibilities with general instructions
  • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
  • Must be willing to travel occasionally (this is an in-house position so very little travel is required)
  • Previous experience as with minimum title of SCRA
  • Study start-up experience is required
  • Global trial experience is desirable
  • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
  • Bachelor’s degree in a relevant scientific discipline or equivalent
  • At least 4 years of relevant clinical experience in the pharmaceutical industry or equivalent (SCRA) and minimum of 7 years for Clinical Program Manager title. 
  • Must have 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment
  • Basic relocation provided

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

100) Sr. Manager Training – Full Time Position (San Francisco Bay Area) T114GR

DESCRIPTION:

Responsible for monitoring the effectiveness of the training program and maintaining compliance with policies, procedures, and applicable GXP regulations.

Key Accountabilities/Core Job Responsibilities:
  • Manage and develop the training department staff.  Mentor staff for individual growth, process efficiency and effective performance.
  • Interact with department management and training representatives to develop training curricula specific to department needs and ensure that department staff are effectively trained on corporate policies, department processes, GxP procedures, and regulatory requirements.
  • Develop processes and tools for the evaluation of training courses, testing and other processes to ensure the effectiveness of the learning and development activities. 
  • Develop training metrics to optimize the performance of the training system to ensure productivity and effective 
  • Maintain a consultative relationship with department training coordinators and with subject-matter experts to enhance the delivery of training content and to identify opportunities for training program improvement.
  • Manage and maintain the ongoing GXP refresher-training program.  
  • Ensure that GXP employees are provided with current GXP training content on a scheduled basis, schedule GXP training on a defined yearly schedule, and track GXP refresher training completion.
  • Acquire and maintain in depth knowledge of GXP compliance trends in order to develop strategies for the delivery of high quality training courses that are relevant to the needs of the organization.
  • Serve as the subject matter expert for training in support of partner and regulatory agency inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Experience developing and implementing course assessments, testing and other processes to ensure the effectiveness of the learning and development activities.
  • Must have an understanding and application of GXPs in the development, clinical, and commercial area of pharmaceuticals products.
  • Knowledge and understanding of the current pharmaceutical industry and applicable domestic and international regulations.
  • The ability to work with subject matter experts to develop and present diverse training topics.
  • BS/BA degree or equivalent and a minimum of 6 years of related experience
  • Minimum of five years experience leading training initiatives and programs for an organization. 
  • Previous training experience in the biotech or pharmaceutical industry highly desirable.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

101) Manager, Quality Assurance – Full Time Position (San Francisco Bay Area) D114QF

DESCRIPTION:

Establishes and maintains QA programs, systems, policies, processes, procedures and controls as they relate to the manufacture, analytical testing, and material disposition of clinical drug substances and drug products manufactured at CMOs.
 
Key Accountabilities/Core Job Responsibilities:
  • Manages all documents received from CMOs through document change control and archival process, as required by internal procedures
  • Independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of drug substance and drug products under clinical development in compliance with US FDA and international health agency requirements.
  • Independently reviews and approves executed manufacturing batch records, analytical data, and associated documentation, including any deviations and investigation reports related to material disposition.
  • Assists with quality investigations and CAPA recommendations related to manufactured products.
  • Manages the clinical product disposition process to ensure quality review and release of clinical products in accordance with domestic and international regulations.
  • Reviews and approves change control requests to ensure compliance with company procedures, cGMP, and other applicable regulations.
  • Represents QA and provides support to the internal CMC team.
  • Provides and prepares quality metrics as needed.
  • Initiate updates and creation of new SOPs as required.
  • Serves as Quality Representative for regulatory inspections as needed.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge and understanding of GMP related requirements, proficiency of regulatory and ICH guidelines. 
  • Broad experience in the pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D a plus.
  • Detail oriented with Quality Assurance background with solid problem solving acumen. 
  • Ability to work effectively in a team environment with great organization skills.
  • Excellent working knowledge of Quality Systems and cGMP standards applicable to clinical trial materials.
  • Ability to analyze and reconcile moderate to complex issues independently.
  • Must be an individual with proven initiative and demonstrated accountability in a fast paced environment.
  • Excellent verbal and written communication and interpersonal skills.
  • Proficient with computers and word processing software (i.e. Microsoft Office products
  • Minimum BA/BS Degree in biological sciences, chemistry, or related field.
  • 9+ years of relative progressive cGMP biotech or pharmaceutical manufacturing environment experience and 6-8 years of operational quality experience executing, developing, and administrating Quality Systems.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

102) Software Quality Engineer – Full Time (Midwest) RG73B

DESCRIPTION:

  • Responsible for ensuring end-to-end quality across a variety of software and data products. Includes functional testing, regression testing, and performance testing it also goes well beyond tests to advocating on behalf of customers, mitigating risks, and promoting best practices  - all while focusing on the big picture and keeping the mission in mind. Immense creativity and a passion for product excellence are expected
  • Define, launch, and enforce best practice processes that promote traceability, reliability, operability, and efficiency in the software delivery process. Mentor and coach a broad mix of technical and non-technical colleagues on these practices. Evangelize verification and validation.
  • Work closely with User Experience, Product Management, and other stakeholders to decipher product requirements, proactively identify product improvements, and push product designs toward quality.
  • Collaborate with engineering teams during product development to document and address quality issues. Review and approve user story cards. Help stakeholders prioritize defects.
  • Lead and execute product testing including development of overall strategies, establishment of performance baselines, capacity forecasting, test automation, tool assessment, and reporting mechanisms.
  • Develop expertise in the company products, software tools, and development processes, using that expertise to identify weaknesses and advocate for quality on behalf of customers.
  • Plan and coordinate release-specific testing efforts with Program/Product management and Scientific QA.

EXPERIENCE AND QUALIFICATIONS:

  • Capable of seeing the forest among the trees, focusing on quality product deliverables, customer satisfaction, and overall testing strategies
  • Strong understanding of testing, tuning exceeding customer expectations of quality.
  • Demonstrated understanding of quality concerns, user-centered design, and software verification and validation techniques.
  • General understanding of the modern software development landscape including cloud computing, architecture stacks, and data storage mechanisms.
  • Acquainted with Selenium, JUnit, and other testing frameworks.
  • Experience leading the evolution from manual testing scripts to automated testing suites.
  • Comfortable working in a fast-paced, dynamic, discovery-oriented environment.
  • Excellent verbal and written communication skills
  • Experience working in an Agile or Scrum environment – preferred, but not required.
  • Experience working in a regulated environment – preferred, but not required.
  • Ability to code in Java (or similar OO language) and SQL as needed for testing – Preferred, but not required.
  • Preferred, not required, background in a scientific, data-oriented domain
  • ISO 9000 training – Preferred, but not required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

103) Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) F114NB

DESCRIPTION:

Description

Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
 
Key Accountabilities/Core Job Responsibilities:
  • Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
  • Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
  • Develop study budget and timelines
  • Prepare regulatory documents and submissions
  • Execute project specific training for internal and external staff
  • Maintain Trial Master File
  • Manage Investigational Product (IP)
  • Manage safety reporting
  • Procure and manage contracts with CROs, study vendors and investigative sites
  • Provide oversight of CROs, independent field monitors and other clinical vendors
  • Review monitoring trip reports and track resolution of all action items
  • Co-monitor at investigative sites to evaluate study site and field monitor performance
  • Collaborate with medical experts, clinical study sites, and clinical study vendors
  • Performs  in-house review of clinical database listings for completeness and accuracy
  • Develops clinical study reports

EXPERIENCE AND QUALIFICATIONS:

  • Excellent verbal and written communication skills
  • Attention to detail
  • Able to organize, manage and set priorities for multiple tasks
  • Strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations
  • Proficiency in MS Word, Excel and Powerpoint
  • Able and willing to travel approximately 25-30%   
  • 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience) 
  • Experience in oncology preferred
  • Experience in global trials preferred
  • Experience with Electronic Data Capture systems preferred 
  • BS/BA degree in a life science, RN, or related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

104) Statistical Programmer III – Full Time Position (San Francisco Bay Area) B114NG

DESCRIPTION:

Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.
 
Key Accountabilities/Core Job Responsibilities:
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Create CDISC SDTM and ADaM files and SAS export files to use for Electronic Submission from the data received in non-standard form from various sources.
  • Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Review Data Management Plan, Data validation plan and edit check specifications
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
  • Recognizes inconsistencies and initiates resolution of data problems.
  • Acts as a liaison between statistical programming, subcommittees and project teams as needed. 
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
  • Acts independently to determine methods and procedures on new assignments.
  • May provide guidance to other lower level personnel.
  • Support lead programmer in generation of analysis datasets, generation of TLFs (Tables, Listings, and Figures), validation of aforementioned data and reports, and maintenance of study documentation
  • Generate and QC summary tables, data listings and figures for in-house analyses of study data or publications using SAS standard coding practices.
  • Validate work of other programmer/analysts at CRO or in-house.
  • Maintain complete and auditable documentation of all programming activities.

EXPERIENCE AND QUALIFICATIONS:

  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experience in the analysis of Oncology clinical trial data a plus.
  • Knowledge of CDISC standard (SDTM & ADaM) a plus.
  • Minimum 5 years Pharmaceutical/Biotech programming experience.
  • NDA submission experience is a plus
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
  • BS in Statistics, Math or Scientific Discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

105) Principal Statistical Analyst/ Senior Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) G114RF

DESCRIPTION:

Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.
 
Key Accountabilities/Core Job Responsibilities:
  • Project lead level activities.
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
  • Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Review Data Management Plan, Data validation plan and edit check specifications
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
  • Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection. 
  • Recognizes inconsistencies and initiates resolution of data problems.
  • Acts as a liaison between statistical programming, subcommittees and project teams as needed. 
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
  • Acts independently to determine methods and procedures on new assignments.
  • May provide guidance to other lower level personnel.
  • Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP)
  • Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
  • Create/acquire tools to improve programming efficiency or quality.
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

EXPERIENCE AND QUALIFICATIONS:

  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experience in the analysis of complex Oncology clinical trial data.
  • Experienced in supervising and mentoring programming staff.
  • Solid knowledge of CDISC standard (SDTM & ADaM).
  • Minimum 12 years Pharmaceutical/Biotech programming experience.
  • NDA submission experience and knowledge required.
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
  • BS/MS in Statistics, Math or Scientific Discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

106) Senior Biostatistician – Full Time Position (San Francisco Bay Area) B114MT

DESCRIPTION:

  • Collaboration with clinical scientists on protocol design (author statistical methods section and generate study randomization)
  • Generate statistical analysis plan for assigned protocols (incl. Mock displays)
  • Assume responsibility for individual studies, write statistical portion of integrated clinical/statistical reports
  • Work with SAS programmer to develop statistical programs to perform analysis, prepare data displays, verify data accuracy and validity
  • Supply statistical input for NDA submissions and in response to FDA queries
  • Provide support for investigator publications
  • Review case report forms, data management plan, and monitoring plan to ensure that protocol objectives are met and project standards are maintained

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials. 
  • Experience with SAS. 
  • Strong interpersonal and effective communication skills
  • Pharmaceutical industry experience required. 
  • NDA submission experience required. 
  • Global submission experience is a plus
  • Education Requirements (degree, certifications, etc.):
  • Ph.D. in Biostatistics or closely related discipline with a minimum of 8 years experience in pharmaceutical and biotech industry.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

107) Clinical Supplies Project Manager – Full Time Position (San Francisco Bay Area) FM110Y

DESCRIPTION:

The Clinical Supplies Project Manager managing the clinical study timelines, deliverables and risks, managing project budget, and participate in internal and external meetings. The Project Manager will work in a project team environment. Internally, the Project Manager will interface directly with multiple functional areas such as: clinical operations, regulatory affairs, medical affairs, commercial, and research as required by the projects assigned to manage. Externally, the Project Manager may be a liaison external alliance partners, vendors and others.

Duties and Responsibilities:
  • Manage clinical trial supplies for multiple studies being conducted internationally.
  • Enhance the efforts of multi-disciplinary drug development teams by ensuring smooth flow of information to all members, by organizing team meetings, preparing Gantt charts, identifying and managing critical path items and by identifying and avoiding and/or solving potential development obstacles.  
  • Identify and lead selection of third-party suppliers and contractors.  
  • Manage outside vendors, including negotiating agreements, developing proposals, and executing the planned work.  
  • Review study results and reports to ensure the adequacy of the data, maintain information tracking databases, prepare and maintain project-related budgets, review invoices and approve payments.  
  • Review, prepare and/or organize documents to support regulatory submissions. 

EXPERIENCE AND QUALIFICATIONS:

  • Prefer B.S. degree in Science (minimum).  
  • Pre-clinical and clinical drug development of investigational new drugs or biologics, familiarity with FDA regulations and guidelines, including cGMPs, cGLPs, and cGCPs, and requirements for INDs and NDAs/BLAs.
  • Exceptionally good interpersonal, verbal and written communication, and organizational skills.  
  • A self-motivated team player with ability to motivate others in a team setting.  
  • Ability to function efficiently, effectively and at times independently in a fast-paced, changing environment.  
  • Ability to recognize and prioritize the most important aspects of the development process as related to company programs and to formulate/implement appropriate strategies and actions to achieve company goals.  
  • Must have well-developed desktop computer skills, including familiarity with the use of word processing, spreadsheet, database, graphics and project management software.
  • 3 to 5 years direct project management responsibility in the pharmaceutical or biotechnology industry working as a member/leader of a project team(s) utilizing internal resources and external contract vendors.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

108) Clinical Supplies Project Manager – Full Time Position (San Francisco Bay Area) FM110Y

DESCRIPTION:

The Clinical Supplies Project Manager managing the clinical study timelines, deliverables and risks, managing project budget, and participate in internal and external meetings. The Project Manager will work in a project team environment. Internally, the Project Manager will interface directly with multiple functional areas such as: clinical operations, regulatory affairs, medical affairs, commercial, and research as required by the projects assigned to manage. Externally, the Project Manager may be a liaison external alliance partners, vendors and others.

Duties and Responsibilities:
  • Manage clinical trial supplies for multiple studies being conducted internationally.
  • Enhance the efforts of multi-disciplinary drug development teams by ensuring smooth flow of information to all members, by organizing team meetings, preparing Gantt charts, identifying and managing critical path items and by identifying and avoiding and/or solving potential development obstacles.  
  • Identify and lead selection of third-party suppliers and contractors.  
  • Manage outside vendors, including negotiating agreements, developing proposals, and executing the planned work.  
  • Review study results and reports to ensure the adequacy of the data, maintain information tracking databases, prepare and maintain project-related budgets, review invoices and approve payments.  
  • Review, prepare and/or organize documents to support regulatory submissions. 

EXPERIENCE AND QUALIFICATIONS:

  • Prefer B.S. degree in Science (minimum).  
  • Pre-clinical and clinical drug development of investigational new drugs or biologics, familiarity with FDA regulations and guidelines, including cGMPs, cGLPs, and cGCPs, and requirements for INDs and NDAs/BLAs.
  • Exceptionally good interpersonal, verbal and written communication, and organizational skills.  
  • A self-motivated team player with ability to motivate others in a team setting.  
  • Ability to function efficiently, effectively and at times independently in a fast-paced, changing environment.  
  • Ability to recognize and prioritize the most important aspects of the development process as related to company programs and to formulate/implement appropriate strategies and actions to achieve company goals.  
  • Must have well-developed desktop computer skills, including familiarity with the use of word processing, spreadsheet, database, graphics and project management software.
  • 3 to 5 years direct project management responsibility in the pharmaceutical or biotechnology industry working as a member/leader of a project team(s) utilizing internal resources and external contract vendors.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

109) Clinical Supplies Project Manager – Full Time Position (San Francisco Bay Area) FM110Y

DESCRIPTION:

The Clinical Supplies Project Manager managing the clinical study timelines, deliverables and risks, managing project budget, and participate in internal and external meetings. The Project Manager will work in a project team environment. Internally, the Project Manager will interface directly with multiple functional areas such as: clinical operations, regulatory affairs, medical affairs, commercial, and research as required by the projects assigned to manage. Externally, the Project Manager may be a liaison external alliance partners, vendors and others.

Duties and Responsibilities:
  • Manage clinical trial supplies for multiple studies being conducted internationally.
  • Enhance the efforts of multi-disciplinary drug development teams by ensuring smooth flow of information to all members, by organizing team meetings, preparing Gantt charts, identifying and managing critical path items and by identifying and avoiding and/or solving potential development obstacles.  
  • Identify and lead selection of third-party suppliers and contractors.  
  • Manage outside vendors, including negotiating agreements, developing proposals, and executing the planned work.  
  • Review study results and reports to ensure the adequacy of the data, maintain information tracking databases, prepare and maintain project-related budgets, review invoices and approve payments.  
  • Review, prepare and/or organize documents to support regulatory submissions. 

EXPERIENCE AND QUALIFICATIONS:

  • Prefer B.S. degree in Science (minimum).  
  • Pre-clinical and clinical drug development of investigational new drugs or biologics, familiarity with FDA regulations and guidelines, including cGMPs, cGLPs, and cGCPs, and requirements for INDs and NDAs/BLAs.
  • Exceptionally good interpersonal, verbal and written communication, and organizational skills.  
  • A self-motivated team player with ability to motivate others in a team setting.  
  • Ability to function efficiently, effectively and at times independently in a fast-paced, changing environment.  
  • Ability to recognize and prioritize the most important aspects of the development process as related to company programs and to formulate/implement appropriate strategies and actions to achieve company goals.  
  • Must have well-developed desktop computer skills, including familiarity with the use of word processing, spreadsheet, database, graphics and project management software.
  • 3 to 5 years direct project management responsibility in the pharmaceutical or biotechnology industry working as a member/leader of a project team(s) utilizing internal resources and external contract vendors.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

110) (Sr) Research Associate, Analytical – Contract (San Francisco Bay Area) B120GT

DESCRIPTION:

  • The candidate will work in a pharmaceutical analytical chemistry group responsible for analytical method development and contract testing of active pharmaceutical ingredients (API) and drug products throughout the development pipeline. 
  • Various analytical techniques, especially HPLC, will be used to establish and monitor both the strength and purity of drug substances and products. 
  • A significant part of job responsibilities will entail review/preparation of controlled documents related to release and stability of drug, standards, and API. As such, comfort with and understanding of industry standards for regulated pharmaceutical testing is required. 
  • Organize, perform and report on high performance liquid chromatography (HPLC), spectrophotometric or other assay and purity measurements of pharmaceutical development candidates as well as related substances or excipients.
  • Establish and appropriately follow test methods, experimental protocols and review procedures.
  • Plan and organize experiments and contract testing to meet specific technical objectives.
  • Adhere to company procedures and policies for laboratory documentation, safety, quality, etc.
  • Use good scientific judgment in all activities.
  • Prepare and/or review written technical reports, batch records, regulatory filings, etc.
  • Participate in group and individual meetings to establish priorities and organize activities and communicate results.

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of quantitative high performance liquid chromatography (HPLC) theory and practice as well as other analytical techniques used in the pharmaceutical industry.
  • Experience working with protein analysis and characterization using state of the art methodologies is a plus.
  • Knowledge of Chromeleon and Chemstation software is a plus.
  • Knowledge of Good Laboratory Practices and/or Quality Control related cGMP’s.
  • Must be able to work safely in an analytical/bio-analytical laboratory with inherent safety issues such as chemicals, infective agents.
  • Bachelor or higher degree in Chemistry, Pharmaceutics, Biology or related major.
  • At least 5 years relevant laboratory experience including HPLC analysis

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

111) (Sr) Research Associate, Analytical – Contract (San Francisco Bay Area) B120GT

DESCRIPTION:

  • The candidate will work in a pharmaceutical analytical chemistry group responsible for analytical method development and contract testing of active pharmaceutical ingredients (API) and drug products throughout the development pipeline. 
  • Various analytical techniques, especially HPLC, will be used to establish and monitor both the strength and purity of drug substances and products. 
  • A significant part of job responsibilities will entail review/preparation of controlled documents related to release and stability of drug, standards, and API. As such, comfort with and understanding of industry standards for regulated pharmaceutical testing is required. 
  • Organize, perform and report on high performance liquid chromatography (HPLC), spectrophotometric or other assay and purity measurements of pharmaceutical development candidates as well as related substances or excipients.
  • Establish and appropriately follow test methods, experimental protocols and review procedures.
  • Plan and organize experiments and contract testing to meet specific technical objectives.
  • Adhere to company procedures and policies for laboratory documentation, safety, quality, etc.
  • Use good scientific judgment in all activities.
  • Prepare and/or review written technical reports, batch records, regulatory filings, etc.
  • Participate in group and individual meetings to establish priorities and organize activities and communicate results.

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of quantitative high performance liquid chromatography (HPLC) theory and practice as well as other analytical techniques used in the pharmaceutical industry.
  • Experience working with protein analysis and characterization using state of the art methodologies is a plus.
  • Knowledge of Chromeleon and Chemstation software is a plus.
  • Knowledge of Good Laboratory Practices and/or Quality Control related cGMP’s.
  • Must be able to work safely in an analytical/bio-analytical laboratory with inherent safety issues such as chemicals, infective agents.
  • Bachelor or higher degree in Chemistry, Pharmaceutics, Biology or related major.
  • At least 5 years relevant laboratory experience including HPLC analysis

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

112) Corporate Paralegal – Full Time Position (San Francisco Bay Area) T111KX

DESCRIPTION:

  • The ideal candidate will have significant experience working on one or more initial public offerings.
  • Prepare board of director and stockholder resolutions, and corporate filings
  • Prepare and oversee required corporate filings
  • Assist with board and stockholder matters
  • Assist with corporate secretary responsibilities for foreign subsidiaries
  • Maintain and organize good corporate books and records
  • Work with multiple departments including finance and tax
  • Participate in the development/review of department forms and procedures
  • Perform other tasks and special projects
  • Assist in preparation and filing of periodic SEC reports (e.g., 10-Qs, 10-Ks, 8-Ks, etc.)
  • Assist with other corporate and securities compliance matters
  • Prepare, process, and manage Section 16 filings for directors and officers
  • Assist with all aspects of corporate transactions including financings and corporate partnering deals.

EXPERIENCE AND QUALIFICATIONS:

  • Paralegal with SEC/IPO experience
  • Excellent organizational and analytical skills
  • Public company experience, including working on public offerings
  • Flexible team-player with excellent interpersonal and communication skills, both written and verbal
  • Demonstrated ability to balance multiple projects, often with competing deadlines
  • Experience leading projects and ensuring on-time and successful completion of tasks
  • Proficiency with Microsoft Office applications, including Excel and Word
  • Project and process management skills
  • Discretion, sound judgment, tact and diplomacy in all communications
  • Strong preference for well-organized, self-assured, self-starters willing to work irregular hours when needed
  • Contracts drafting and negotiation experience is a strong plus
  • Mandarin helpful but not required
  • BA/BS and/or ABA-approved paralegal certificate, or other comparable legal experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

113) Clinical Contracts Administrator / Paralegal – Full Time Position (San Francisco Bay Area) GY111P

DESCRIPTION:

  • Experience working on clinical contracts in the biotech/pharma setting and significant experience working on international clinical studies.
  • Assist attorneys and team members in the intake, drafting, negotiation and post-execution administration of non-disclosure, material transfer, clinical trial, vendor services, and other agreements. 
  • Must be a self-starter and comfortable working in a fast-paced environment with high volume production requirements, and meeting frequent tight deadlines under minimal supervision. 
  • Manage the process and workflow of contracts, assure compliance with existing agreements, and ensure the proper routing of documents for full execution by corporate officers and outside parties and perform other duties as assigned by 
  • attorneys and other team members. 
  • Prepare drafts of agreements and negotiations with outside parties
  • Gather and confirm facts necessary to initiate contract formation with  Legal team and internal stakeholders
  • Generate initial contract drafts and prepare successive redlines
  • Perform initial review of contracts and comments from outside parties
  • Negotiation with outside parties
  • Prepare/format and finalize contracts for execution
  • Work with the Legal team to administer a document-tracking database, including data entry and the generation of summary reports on agreement status
  • Monitor contracts for compliance with company and department policies
  • Perform other tasks as assigned by the Legal team members

EXPERIENCE AND QUALIFICATIONS:

  • Minimum of three years’ experience in the review, negotiation and administration of clinical contracts (biotech preferred)
  • Familiarity with the clinical study process
  • Intellectual property law background preferred
  • Excellent communication skills, both written and verbal
  • Excellent organizational and analytical skills
  • Demonstrated proficiency with Microsoft Office applications (Word, Outlook, Excel, Access) and experience with contract management and database applications
  • Flexible team-player with ability to balance multiple projects and instructions often with competing deadlines
  • Creative, self-motivated, self-starter with strong organizational, prioritization and interpersonal skills
  • BA/BS and/or ABA-approved paralegal certificate, or other comparable legal experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

114) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

DESCRIPTION:

This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices.
 
Key Accountabilities/Core Job Responsibilities:

  • Develops and oversees CTMF document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established  procedures and policies.
  • Develops document management systems to meet the needs of the Clinical Development department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF).
  • Develops, implements and maintains CTMFs for all clinical trials.
  • Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents.
  • Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance with regulatory requirements and  procedures and processes.
  • Manages and controls the paper-based CTMF storage room and its contents.
  • Manages and controls the eCTMF storage and maintenance systems.
  • Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and maintained in accordance with all applicable regulatory requirements and  procedures and processes.
  • Develops and manages the archiving systems and retrieval of archived CTMF documents.
  • Functions as the Subject Matter Expert for CTMF document management systems and processes within
  • Provides CTMF support and guidance for internal and external CTMF audits.
  • Provides CTMF support and guidance for US and Ex-US regulatory authority inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge of current paper-based CTMF systems and standards and GCPs.
  • Excellent working knowledge of current electronic CTMF systems and standards.
  • Ability to analyze and reconcile complex issues independently.
  • Ability to independently and effectively manage assigned task and projects.
  • Ability to lead and manage CTMF support personnel.
  • Ability to develop or update Standard Operating Procedures and Work Instructions.
  • Excellent verbal and written communication and interpersonal skills.
  • Must be an individual with proven initiative and demonstrated ability in a fast paced environment
  • Established experience and knowledge of general CTMF systems and standards.
  • Established experience and knowledge of paper-based document CTMF systems.
  • Established experience and knowledge of electronic CTMF systems.
  • Established experience providing CTMF support for US and Ex-US regulatory authority inspections
  • Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements.
  • Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite.
  • Established experience with design, development and implementation of a paper-based CTMF storage room.
  • Established experience with identification, selection, implementation and maintenance of an electronic CTMF system.
  • Established understanding and experience with Web-based applications for controlled document indexing, tracking and viewing.
  • Must have Bachelor’s Degree or equivalent with a minimum of 8 years of relevant pharmaceutical or biotech CTMF development and management experience, or equivalent experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

115) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

DESCRIPTION:

This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices.
 
Key Accountabilities/Core Job Responsibilities:
  • Develops and oversees CTMF document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established  procedures and policies.
  • Develops document management systems to meet the needs of the Clinical Development department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF).
  • Develops, implements and maintains CTMFs for all clinical trials.
  • Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents.
  • Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance with regulatory requirements and  procedures and processes.
  • Manages and controls the paper-based CTMF storage room and its contents.
  • Manages and controls the eCTMF storage and maintenance systems.
  • Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and maintained in accordance with all applicable regulatory requirements and  procedures and processes.
  • Develops and manages the archiving systems and retrieval of archived CTMF documents.
  • Functions as the Subject Matter Expert for CTMF document management systems and processes within
  • Provides CTMF support and guidance for internal and external CTMF audits.
  • Provides CTMF support and guidance for US and Ex-US regulatory authority inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge of current paper-based CTMF systems and standards and GCPs.
  • Excellent working knowledge of current electronic CTMF systems and standards.
  • Ability to analyze and reconcile complex issues independently.
  • Ability to independently and effectively manage assigned task and projects.
  • Ability to lead and manage CTMF support personnel.
  • Ability to develop or update Standard Operating Procedures and Work Instructions.
  • Excellent verbal and written communication and interpersonal skills.
  • Must be an individual with proven initiative and demonstrated ability in a fast paced environment
  • Established experience and knowledge of general CTMF systems and standards.
  • Established experience and knowledge of paper-based document CTMF systems.
  • Established experience and knowledge of electronic CTMF systems.
  •  Established experience providing CTMF support for US and Ex-US regulatory authority inspections
  • Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements.
  • Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite.
  • Established experience with design, development and implementation of a paper-based CTMF storage room.
  • Established experience with identification, selection, implementation and maintenance of an electronic CTMF system.
  • Established understanding and experience with Web-based applications for controlled document indexing, tracking and viewing.
  • Must have Bachelor’s Degree or equivalent with a minimum of 8 years of relevant pharmaceutical or biotech CTMF development and management experience, or equivalent experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

116) Director, Statistical Programming – Full Time Position (San Francisco Bay Area) X111JP

DESCRIPTION:

  • Lead the statistical programming activities for multiple compounds and will lead the programming submission related activities. 
  • Establish standards for programming and efficiency within the group.
  • Manages a team of statistical programmers.
  • Identifies new tools to increase group productivity.
  • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
  • Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent. 
  • Excellent verbal and written communication skills and interpersonal skills are required.Has understanding of the business beyond the functional area.
  • Capable of recommending new operating procedures as appropriate and determining if the analysis infrastructure needs changes to improve efficiency and minimize errors.
  • Must be able to lead strategic initiatives for the statistical programming group.
  • Represents the statistical programming group at project team meetings.
  • Has the proven ability to directly supervise personnel.

EXPERIENCE AND QUALIFICATIONS:


  • Submission, ISS, and ISE expertise
  • Leadership skills
  • Experience in multiple therapeutic areas is desired
  • Experience in clinical development statistical programming methods and processes in industry setting required
  • Experience in direct management of statistical programmers
  • Experience and in-depth knowledge in CDISC including SDTM, ADaM, Metadata, and controlled terminologies
  • Enable to establish process and develop utilities efficiently for different versions of Implementation Guides and Standards. Enable to assess the impact of procedural or system changes , and develop/implement strategies to maintain consistency of programming
  • Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
  • Good presentation, oral and written communication skills, including a customer base focus, a commitment to quality management, and problem solving experience. 
  • 11 years of experience and a BS degree in Biostatistics/Computer Science or equivalent, or 7 years of experience and a MS degree in Biostatistics/Computer Science or equivalent, or 5 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

117) IVD Systems & Verification Engineer – Full Time Position (San Francisco Bay Area) B118HZ

DESCRIPTION:

  • Work closely with marketing to develop product requirements. 
  • Work closely with other senior technical staff to identify the key technical challenges to meeting said requirements, and develop system architectures for IVD products.  
  • Improve on the process for system and sub-system verification, including test automation and traceability to requirements, specifications and risk. Partake in verification and validation testing as needed. These responsibilities also apply to integration testing. 
  • Perform system level modeling to determine power consumption, throughput/speed, cost, etc.,  for complex IVD products.
  • Perform risk analysis, compliant to relevant international standards, for products in development.  
  • Some lab work with blood based in vitro diagnostics. 
  • Support activities and processes in compliance with applicable international standards and FDA guidelines.

EXPERIENCE AND QUALIFICATIONS:

  • Travel requirements: up to 10%. 
  • Experience with Regulatory requirements for IVD products
  • Experience with SysML and/or UML, Fluidic and electromechanical systems  
  • Experience with MATLAB/Simulink
  • Experience with Code development in one or more of the following: C#, C, Python
  • Experience with DOE, Statistics, and associated tools
  • Good written and oral communication skills are a must.
  • At least eight years overall engineering experience, with at least five years in the medical device or diagnostics industry, or other highly regulated industry (e.g., aerospace, automotive), including one or more successful product launch.
  • Direct experience in test automation, and generally improving the process of verification.
  • Direct experience solving complex system engineering issues, including the interaction of the instrument, assay and consumables, and user.
  • Direct experience working with marketing in the product definition stage, and continuing to the successful verification and validation of a product.
  • BS in Electrical, Mechanical, or Biomedical Engineering. M.S. or Ph.D. is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

118) Recruiter – Contract (Pennsylvania) 7757

DESCRIPTION:

  • Will focus on manufacturing and research and development related positions. 
  • Responsible for partnering with the organizations they support along with the HRBP's. 
  • Ownership/accountability for all openings in client family.  
  • Educate client groups on recruiting/staffing processes. 
  • Document/track recruiting activities in system. 
  • Coach managers on the selection process. 
  • Source, screen and interview candidates

EXPERIENCE AND QUALIFICATIONS:

  • Must be self-motivated, present well and be able to develop relationships with both managers and candidates. 
  • Ability to navigate through change and demonstrate flexibility as organizational needs shift. 
  • 5+ years of solid recruiting experience. 
  • Must develop and implement creative sourcing strategies to identify talent.
  • Bachelor degree preferred with minimum of 5 years relevant experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

119) Document Control Specialist – Contract (San Francisco Bay Area) 2039N73

DESCRIPTION:

  • Individual will be transferring data to template form.  
  • Must be comfortable with and familiar with QC.  
  • Will be working under supervision but will be required to produce and work well in a faced paced environment.   

EXPERIENCE AND QUALIFICATIONS:

  • Conducts all activities in a safe and efficient manner
  • Good organizational skills and attention to detail reliability.
  • Must have excellent interpersonal skills, writing skills, and communication skills.
  • Individual must work well with others, in a positive, collaborative work environment
  • May be required to perform other related duties as required and/or assigned.
  • BS with 1-2 years of experience in QC or Biotech environment or AS with 3-5 years.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

120) Senior QA Specialist, Manager – Contract to Full Time (San Francisco Bay Area) BK106P

DESCRIPTION:

  • Ensure that product and process changes are properly qualified prior to becoming effective. 
  • Review validation activities (IQ/OQ/PQ) including protocols and final reports related to manufacturing processes including inspection equipment and analytical test methods.
  • Establish and manage the design and development process.
  • Manage product risk management file updates, risk assessments to support complaints, CAPAs, and related product risk assessments.
  • Perform training to support compliance to internal procedures and external regulations.
  • Develop and enhance measurement, inspection and test systems for existing products and processes. 
  • Maintain and develop quality assurance inspection and test procedures and work instructions.
  • Coordinate and perform audits of both internal and external operations.  
  • Identify compliance risks and report findings to appropriate management with recommendations for resolution.
  • Design History Record/Batch record review and product release including review of analytical test data.
  • Establish and maintain quality engineering methodologies such as design control, change control, quality planning, complaint handling, auditing, CAPA and supplier management. 
  • Provide quality engineering support/product risk management and technical problem-solving.
  • Review and approval of facility, equipment and manufacturing process/change control documentation.

EXPERIENCE AND QUALIFICATIONS:


  • Strong knowledge of drug cGMP (21 CFR Parts 210, 211 and 820); Knowledge of device or combination product highly desierable
  • Excellent written and verbal communication skills.
  • Experience with analytical and statistical techniques such as DOE.
  • Ability to critically evaluate and troubleshoot complex problems is essential. 
  • Must take initiative and be solution oriented.
  • Must be able to work in a team oriented, fast paced environment with multiple priorities.
  • Minimum 5+ years in drug delivery or combination (drug/device) products.
  • BA/BS Degree in scientific discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

121) Process Engineer Expert – Full Time Position (San Francisco Bay Area) QG116P

DESCRIPTION:

  • Supports the PU in all process-specific issues, drives continuous process improvement for quality and quantity and ensures GMP requirements are met and guidelines and SOPs are followed. 
  • Provide continuous supply of high quality products that meet technical specifications, cGMP, regulatory policies and procedures. 
  • Root cause analysis and investigation for deviations and complaints (external and internal). 
  • Lead and/or support of decision making for manufacturing problems. 
  • Continuous process verification (establishes QRAs, performs process monitoring). 
  • Provide input on process performance for APR/PQRs

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of a process oriented organization and self- directed culture a plus.
  • Bachelors in Science or Chemical Engineering
  • Minimum of 10 years experience in the pharmaceutical/chemical industry. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

122) Sr. Database Developer (Software Engineering III) – Two Full Time Positions (Midwest) G73RP

DESCRIPTION:

Description:
There are 2 positions, one with more validation and verification. The purpose of the Database Developer is to apply best-practices of engineering disciplines to the management of large amounts of complex data, and to provide oversight and leadership to the Development Team. The emphasis is on data analysis, data integration, systems integration, and system administration but this position will also have some software development.  The technical challenge is natural language processing, big data analysis, requirement identification, prototyping, design and implementation through to customer acceptance. 

Essential Functions:
  • Use prior knowledge and experience to provide functional support and leadership to colleagues
  • Responsible for initial design and development of new database, software and/or extensive revisions.
  • Define technical requirements and create high-level architectural specifications, ensuring feasibility, functionality, and integration with existing systems/platforms
  • Demonstrate expertise in a variety of the field's concepts, practices, and procedures. Rely on extensive experience and judgment to understand complex problems and resolve them efficiently
  • Participate in training and orienting new engineers as they join the team
  • Manage the care and feeding of large and complex data stores serving multiple internal and external consumers
  • Transition R & D reference bioinformatics methods/implementations into operational offerings
  • Integrate third-party database, data transformation, and data visualization systems
  • Design, build, and maintain internal tools to support data curation and ongoing research
  • Maintain existing suite of customer-facing solutions including substantial system and database administration

EXPERIENCE AND QUALIFICATIONS:

  • Skilled in SQL and object-oriented programming (Java preferred, but Ruby, Python, C++, etc. considered) including common data structures
  • Prior exposure to scripting languages (e.g. Perl, Bash), Linux, and web development
  • Data storage and management expertise using a variety of traditional (Oracle, MySQL) and non-traditional “big data” technologies (MongoDB, CouchDB, Cassandra, Neo4j)
  • Experience with data modeling, data integration, data analysis, data mining, database design, and ETL technologies
  • Comfortable with or willing to learn a variety of system administration tasks (command-line interfaces, Linux, yum, CPAN, networking and firewalls, etc.)
  • Values simplicity in software architecture, design, and practices (DTSTTCPW, YAGNI, refactor ruthlessly)
  • Has proven experience with testing and testability
  • Masters and/or Ph.D degree and/or minimum 6 years work experience in related fields.
  • Experience in natural language processing – Preferred, but not required.
  • Experience interacting with semantic web ontologies (OWL, RDF) – Preferred, but not required.
  • Experience working in an Agile or Scrum environment – Preferred, but not required.
  • Experience working in a regulated health sciences related environment – Preferred, but not required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

123) Clinical Trial Manager – Contract (San Francisco Bay Area) JX111Q

DESCRIPTION:

  • Manage Phase 2 global clinical study, CRO’s and Vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
 

EXPERIENCE AND QUALIFICATIONS:

  • Must be hands on and used to a start-up environment
  • Knowledge of GCP and ICH guidelines required
  • Proficiency in the implementation, monitoring, and management of clinical trials
  • Able to work collegially within a team and carry out duties/responsibilities with general instructions
  • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
  • Must be willing to travel occasionally (this is an in-house position so very little travel is required)
  • Previous experience as a CPM managing more than one trial in Phase 3 or Phase 2B trial
  • Study start-up experience is highly desirable
  • Global trial experience is highly desirable
  • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
  • At least 6 years of relevant clinical experience in the pharmaceutical industry or equivalent with 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment, and 1 year prior experience as a CPM preferred
  • 1+ years managing staff/direct reports preferred
  • Bachelor’s degree in a relevant scientific discipline or equivalent

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

124) Senior Director, Healthcare Compliance – Full Time Position (San Francisco Bay Area) BR114F

DESCRIPTION:

Candidate will partner with the leaders of the Commercial, Medical Affairs and Clinical teams, while ensuring that these business units are in compliance with company compliance policies and SOPs.  This role will lead the implementation of corporate compliance programs in multiple departments, and will oversee the design and maintenance of such programs, including but not limited to, maintaining, reviewing and updating Policies and Procedures, developing and conducting training and working in conjunction with the Compliance Operations function to ensure compliance within the company and across business units.  The successful candidate will have exceptional verbal and written communication skills, and be a collaborative, team-player with a demonstrated ability to influence people at all levels of the company to take action.  The candidate will be a strong leader and manager, with experience managing a growing team of professionals at different levels

Job Responsibilities:
  • Support the Chief Compliance Officer in building and operationalizing a robust and effective Corporate Compliance Program for a fast-paced, rapidly growing, company emerging into the Commercial market.
  • Assist the Chief Compliance Officer in the development and implementation of, compliance policy and SOPs, audit/monitoring programs and/or other risk detection and evaluation techniques to monitor compliance.
  • Provide leadership in compliance and further ownership/accountability for compliance & ethics throughout the identified departments within the organization. Effectively and efficiently identify compliance risks, prioritize focus, and implement appropriate Compliance & Ethics controls and management systems as seen with company activities such as sales and marketing, medical affairs, clinical trials, advisory boards, grants, sponsorships and charitable contributions, market access, and other activities.
  • Work cross-functionally with Legal, HR and other stakeholders on planning and implementing company and department specific compliance education programs and content customization. Will require both development and implementation of training programs and management of various 3rd party vendors for training
  • Effectively collaborate with Corporate Compliance teams of third-party business partners and business alliances, while supporting company business in meeting its goals in a compliant fashion
  • Coordinate with Legal, and other stakeholders to conduct reviews of business activities against company’s corporate compliance policies and procedures, and participate in and provide guidance for investigations and internal audits, as deemed necessary.
  • Champion proper resources are integrated with the business to help identify and implement opportunities for improvement in the effectiveness and efficiency of compliance and ethics programs. Implement appropriate metrics to drive desired compliance and ethics focus, behavior and results.

EXPERIENCE AND QUALIFICATIONS:

  • Experience in designing, building and implementing a successful corporate compliance program in a pharmaceutical/biotech company
  • Proven record of accomplishment in the areas of drafting and implementing compliance policies, training, auditing, monitoring and investigations
  • Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including OIG and PhRMA guidelines, healthcare standard operating procedures, federal sunshine act, Foreign Corrupt Practices Act, the UK bribery act, and other anti-bribery laws federal state marketing disclosure laws, and state price reporting statutes,
  • Excellent oral and written communication skills, including presentation capabilities, and the ability to effectively influence employees across departments and throughout the company, including at Senior Management level
  • Exceptional interpersonal skills, and a collaborative team-player, with ability to resolve conflicts at all levels of the organization
  • Experience working with third-party business collaboration partners and in business alliances helpful
  • Ability to recruit and manage a high performing compliance team consisting of professionals at various levels and with various duties
  • Ability to work in a fast-paced, rapidly expanding environment, and to handle multiple complex and confidential tasks, in an organized and efficient fashion to ensure meeting very aggressive project deadlines are met in a timely manner
  • 10-15 years pharmaceutical/biotech company experience,  with 8-10 years of legal, regulatory and/or corporate compliance related experience required
  • Certified Compliance and Ethics Professional (CCEP) certification helpful, but not required
  • Bachelors degree required and Law degree (Juris Doctor) or post-graduate Healthcare related degree strongly preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

125) Regulatory Analyst – Full Time Position (Maryland) BX73F

DESCRIPTION:


  • Assist customers by providing regulatory guidance and support as it applies to the use of its products and services.  
  • Prepare U.S. 510(k) regulatory submissions, preparation/maintenance of Technical Files for European CE-IVD products  
  • Prepare regulatory submissions for health authorities in other countries.  
  • Prepare and maintain state and federal medical device licensing, establishment registration and listings, MDR reporting. 
  • Obtain regulatory permits, including compliance with import / export clearance requirements and regulations.  
  • Regulatory assessment of new and changed products.  
  • Labeling / marketing material review.   
  • Participate in Project Teams and New Product Introduction Teams.  
  • Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.  
  • Conduct training and/or communicate appropriate material to internal staff to aid in compliance.  
  • Develops regulatory affairs internal policies and procedures, and provide compliance training.  
  • May perform audits, both physical and paper, to ensure compliance with various regulations.  
  • May coordinate audit through outside vendor.

EXPERIENCE AND QUALIFICATIONS:

  • In-Vitro Diagnostic/Medical Device regulatory affairs:   Regulations, Submissions (510(k), PMA, IDE), Technical Files (IVDD), CMDL, cGMP/Quality Systems, Regulatory Compliance and Import/Export regulations.  
  • Direct and positive experience in communicating with Regulatory Authorities and Distributors.  
  • High energy level; positive attitude; works well under stress
  • Strong communicator 
  • Hands-on, action-oriented, and able to implement effectively through his/her team
  • Continuous improvement minded; used to balancing the need for quality and the need for efficiency
  • Good business sense for what’s practical, and what’s not, what’s needed for what parts of the business.  
  • Good sense for operations in general.  
  • Able to effectively operate in a cost-conscious environment.  
  • Willingness to travel (~40%)
  • Must have a minimum of 5 years of Regulatory Affairs In-Vitro Diagnostic Medical Device technical work experience, or an equivalent combination of education and experience.  
  • Regulatory certification is a plus.  
  • A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.  M.S. or M.B.A. is a plus.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

126) Senior Project Manager – Full Time Position (San Francisco Bay Area) B114TG

DESCRIPTION:

  • Partner with Team Leader to manage the development and execution of project team strategy and to optimize team effectiveness in achieving project objectives in alignment with budget and timeline.
  • Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes; ensures alignment with project sub-teams and functional partners.
  • Oversees and prepares project team budget including resources and costs collaborating with finance and other cross-functional departments
  • Ensure project team activities and decisions are clearly communicated, documented and archived, act as a primary contact for project team related information.
  • Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders.
  • Identifies, recommends, and manages the implementation of process and other improvements; whether pertinent to departmental and/or corporate.
  • Effectively managing day-to-day operating requirements and communications for assigned alliances
  • Develop and maintain alliance relationships between companies
  • Responsible for communicating alliance project information to Senior/Executive Management.
  • Plan and coordinate implementation activities with partner
  • Manage shared repository for all communications, important documents and data for use with partner
  • Support CMC or other sub-teams as necessary

EXPERIENCE AND QUALIFICATIONS:

  • Strong proficiency with project management practices, tools, and methodology.
  • Outstanding knowledge of overall drug development process relevant to pharmaceutical/biotech organizations.
  • Financial acumen; capable of planning and oversight of project budgets and product valuations and an understanding of portfolio management concepts.
  • Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
  • Excellent analytical skills, with an ability to communicate complex issues in a simple way.
  • Demonstrate ability to translate strategy into action.
  • Strong influence, negotiation, and presentation skills.
  • Proven track record of good decision-making and exercising sound judgment.
  • Results and detail-oriented; self-motivated.
  • Proven experience using Project Management software to manage complex project timelines and resources.
  • Advanced degree is desired (e.g. MS, PhD, MBA) or commensurate experience
  • 8 or more years multi-disciplinary experience in the biotech/pharmaceutical industry, with 4 - 8 years direct project management in drug development

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

127) Clinical Trial Manager / Sr Clinical Trial Manager – Full Time Position (San Francisco Bay Area) RF117Q

DESCRIPTION:

  • Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs
  • Independently oversees and tracks study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.
  • Initiates and participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents.
  • Oversees and works directly with CROs, vendors, investigators, monitors and other external partners.
  • Leads and participates in internal cross-functional clinical team meetings; serves as main point of contact study-level status updates.
  • Leads and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set-up, CRFs, regulatory documents, and site contracts in conjunction with relevant departments.
  • Supports and coordinates tasks related to data management, participates in database creation and user acceptance testing, input for edit checks and monitoring guidelines, data cleaning activities between study sites, data management and field monitors.
  • Supports CPM in coordination of receipt of all ancillary data e.g. safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock.
  • Conducts Trial Master File review and line listing data review

EXPERIENCE AND QUALIFICATIONS:

  • Experience: 7-10+ years clinical research experience in a pharmaceutical/biotech, CRO setting, monitoring experience
  • Phase 3 experience strongly preferred
  • Immunology or Oncology clinical trial experience preferred
  • Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
  • Strong interpersonal, organizational, and multi-tasking skills
  • Able to work independently
  • Excellent attention to detail and problem solving skills
  • Ability to work effectively work in a team setting
  • Travel domestic – up to 25%
  • Science background BS or healthcare degree required, Masters preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

128) Clinical Project Manager – Full Time Position - 1-2 days/wk in-house (San Francisco Bay Area) ZG104M

DESCRIPTION:

  • Prepares and revises clinical protocols and informed consent documents
  • Participates in development of case report forms
  • Manages study supplies
  • Recruits and qualifies investigational sites for participation in clinical studies
  • Ensures studies are conducted in compliance with regulatory requirements
  • Oversees monitoring and close-out of study sites
  • May be able to work 20-40% from home, 1-2 days on site

EXPERIENCE AND QUALIFICATIONS:

  • Must be able to work independently while contributing to a team; take initiative
  • Demonstrate excellent verbal and written communication skills
  • Familiarity with medical and pharmaceutical industry terminology and practices
  • Proven effectiveness as a team leader
  • Prior experience successfully managing multifaceted studies from inception through implementation and completion.
  • Computer proficiency in Microsoft Word, Excel, and PowerPoint are required. 
  • Experience with MS Project a plus
  • Ophthalmology or Oncology experience required
  • 4-year degree, preferably in a scientific or health care discipline
  • 4-5 years of prior experience in the Clinical Research Associate role, plus at least two years of CPM experience.
  • 25-40% travel domestic

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

129) Senior Regulatory Affairs Specialist – Full Time Position (San Francisco Bay Area) RY115M

DESCRIPTION:

  • Execute and manage technical and scientific regulatory activities. 
  • Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met.  
  • Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. 
  • Properly interpret and apply regulatory requirements.  
  • Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. 
  • Work is reviewed upon completion for adequacy in meeting objectives. 
  • Assist in SOP development and review
  • Provide regulatory input to product lifecycle planning
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing
  • Compile, prepare, review and submit regulatory submission to authorities
  • Monitor impact of changing regulations on submission strategies
  • Maintain annual licenses, registrations, listings and patent information
  • Assist compliance with product postmarketing approval requirements
  • Review and approve advertising and promotional items to ensure regulatory compliance
  • Assess external communications relative to regulations

EXPERIENCE AND QUALIFICATIONS:

  • Must be fluent (verbal/written) in Japanese
  • Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents
  • Knowledge of submission/registration types and requirements and GxPs (GCPs, GLPs, GMPs)
  • Principles and requirements of promotion, advertising and labeling
  • International treaties and regional, national, local and territorial trade requirements, agreements and considerations
  • Domestic and international regulatory guidelines, policies and regulations
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 
  • 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 
  • 3-4 years experience in a regulated industry
  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

130) Administrative / Professional - HR – Contract (New Jersey) 9919

DESCRIPTION:

  • Handles routine customer service inquires related to human resources, payroll and benefits administration and provides Q&A support as needed. 
  • Opens tickets and logs calls into a computerized call tracking system  
  • Answers questions by primarily relying on standard screens, scripts and procedures for call resolution. 
  • Works closely with the other components of the HR function to escalate cases and sufficiently address customer needs.
  • Uses procedures, policies, knowledge database and other reference materials to assist in answering employee, manager and agency HR, payroll or benefits representative inquires.
  • Guides employees and managers on using the on-line tool.
  • Receives and processes employee data change requests or appropriately escalates issues.
  • Collects and validates complete data required to process manual employee personal and organizational transactions and escalates the completed data to the center for processing.
  • Escalates complex issues/inquires to other parts of HR or redirects calls to ITS or other appropriate groups.
  • Provides support and coaching to peers.
  • Participates in continuous improvement workshops and project

EXPERIENCE AND QUALIFICATIONS:

  • One or more years of general HR experience.
  • Ability to follow strict policy guidelines.
  • Ability to navigate computerized data entry system and other relevant applications.
  • Ability to recognize situations requiring call escalation.
  • Ability to follow standard procedures and scripts without variation.
  • HRIS experience preferred.
  • Strong oral communication skills.
  • Strong listening skills.
  • Strong customer service focus.
  • High School Degree or equivalent work experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

131) Senior Statistical Programmer – Full Time Position (San Francisco Bay Area) ZA111H

DESCRIPTION:

  • Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings.
  • Design, develop, implement, and maintain software for the monitoring of ongoing studies, reporting, and analysis of clinical trials. 
  • Provide consistency across protocols within a project on CRFs, database design, analysis files, and tables, listings, and graphs.
  • Produce data listings, summary tables and graphics for interim and final analyses and publications.
  • Create statistical files for statistical analysis. 
  • Integrate data across studies within a project. 
  • Test, document, review and validate all programs according to department guidelines.
  • Provide consulting and systems support for applications software. 
  • Develop new applications software and identify key feature set.
  • Coordinate data transfer and/or programming standards with CROs and vendors. 
  • Work with minimal supervision.

EXPERIENCE AND QUALIFICATIONS:

  • Expertise in SAS programming language (especially data step, and summarization procedures), report generation, and standards for programming and validation.
  • Experienced in macro writing. 
  • Knowledge of advanced statistical procedures in SAS including LIFETEST, MIXED, GLM, especially SAS/GRAPH (required). 
  • Experience with CDISC data standards required.
  • Knowledge of database and data warehouse theory. 
  • Data mining experience is a plus.
  • Understanding of regulatory guidelines that affect statistical deliverable.
  • Ability to work on multiple tasks simultaneously and meet project deadlines.
  • Good verbal and written communication skills.
  • MA/MS in a related field with 5 years experience, or BA/BS in computer science, statistics, math with 7 years experience. 
  • Minimum of 7 years of SAS programming and 5 years of clinical trial experience.
  • Mandarin language skills is a plus but not required

To apply for a position send your resume to Jobs@JGBBioPharma.com

Back to Top

linebreak

132) Engineer III QA \ QC – Full Time Position (Wisconsin) B73NG

DESCRIPTION:

Support U.S. and International In-Vitro Diagnostic Medical Device quality management system activities. The incumbent works in Global Quality Assurance department to establish and maintain appropriate quality systems to ensure compliance consistent with state, federal and international law. Responsible for ensuring that processes needed for the Quality Management System (QMS) are implemented, maintained and compliant with a range of quality regulations and standards including 21CFR part 820 and ISO 13485. Guides the development and assists in the implementation of validation plans (including software, equipment and process validation plans), manages training systems, participates in audits and assists in all other functions of the Quality Assurance group.
    • Guides the development and assists in the implementation of validation plans (including software, equipment and process validation plans).
    • Implements and improves various quality systems including training, non-conformance, complaint, CAPA, FMEA and change request systems.
    • Guides problem solving and identification of root cause and follows up on corrective and preventive actions to ensure timely resolution of such problems.
    • Prepares clearly written business communications, Management Review reports, and investigation summaries.
    • Performs internal audits and use auditing as a proactive tool for improvement and compliance.
    • Participates in cross-functional team projects (R&D, Mfg, vendors, etc) for new product introductions and quality improvements.
    • Works with suppliers to resolve complex quality issues and qualify suppliers.
    • Supports Company Safety, Environmental and Waste disposal programs.
    • Conveys matters of concern to department manager.
    • Maintains the highest personal working standards and performance with emphasis on self-discipline, quality and service thus upholding the company’s commitment to customer satisfaction.
    • Performs any other duties, expressed or implied, as required.

    EXPERIENCE AND QUALIFICATIONS:

    • High energy level; positive attitude; works well under stress
    • Strong communicator, both written and oral
    • Hands-on, action-oriented, and able to implement effectively
    • Driven to continuous improvement
    • Easily defines, executes and leads validation and quality improvement plans.
    • Willingness to travel occasionally
    • Track record of working collaboratively with manufacturing and operations, so that quality becomes everyone’s job and an “us versus them” relationship isn’t fostered.
    • Comfortable with a range of software programs in a near paperless environment.
    • Quality Assurance/Auditing experience in a chemical/manufacturing industry. 
    • Experience in training, validation, problem solving tools, and understanding of statistics.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    133) (Sr) Manager Regulatory – Full Time Position (San Francisco Bay Area) KS132P

    DESCRIPTION:

    • Actively contributes in the development and implementation of regulatory strategies for product development and approval.  
    • Responsible for specific regulatory document, submission, and compliance issues.  
    • Provide regulatory support to other departments, project teams, and committees in managing the development of company products. Interaction with FDA representatives.
    • Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (INDs, MFs, IMPDs, CTXs, etc.), and prepare for the filing of subsequent licensing applications (NDA, MAA, e-CTD, etc.).
    • Coordinate multiple submissions and projects effectively
    • Execute, independently or with very limited guidance and supervision, product development and regulatory strategies regarding submissions and compliance issues
    • Assess and exercise good, independent judgment in interpretation and implementation of governmental regulations and procedures. 
    • Maintain, organize, prepare and review, clear and effective submissions for existing and new products
    • Manage interdepartmental regulatory matters and provide regulatory guidance to internal personnel (e.g., executive committee; project teams; clinical, preclinical, and manufacturing departments and subcommittees; etc.)
    • Direct interaction with regulatory agencies on defined matters.  Build and maintain excellent relationships with FDA personnel and representatives from corporate partners
    • Foster teamwork and improve intra-/inter-departmental communications
    • Supervise regulatory staff and guide subordinates in carrying out responsibilities.  
    • Coordinate subordinate activities and career development
    • Actively participate in and contribute to various meetings, e.g., project teams, departmental regarding regulatory and product development issues
    • Position will regularly interact with all departments and all levels within a department
    • Position may have direct reports

    EXPERIENCE AND QUALIFICATIONS:

    • Thorough working knowledge and understanding (application of knowledge/experience) of FDA regulations
    • Ability to learn and assimilate scientific information
    • Minimally five years regulatory pharmaceutical/biotechnology industry experience
    • Experience and knowledge in the preparation of NDAs and global submissions; Commericial product experience nice to have.
    • Some previous experience in interpretation of FDA regulations, guidelines, policy statements, etc.
    • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
    • Knowledge of GMPs, GLPs, and GCPs
    • Well organized, detail oriented, effective written and oral communication skills, and good grammatical skills
    • Ability to guide, train, and supervise personnel
    • Computer literate
    • Previous experience in managing interactions with FDA and other regulatory authorities preferred.
    • Previous regulatory/technical management experience preferred
    • B.S. degree in sciences, preferably life science.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    134) Coordinator, Materials Process Management – Full Time Position (San Francisco Bay Area) WG96H

    DESCRIPTION:

    • Will act as a coordination expert in handling all aspects of regulatory projects in advertising and promotion.
    • Prepare and submit approved branded promotional materials on 2253 forms prior to first use
    • Manage materials approval committee submission process
    • Evaluate submissions to ensure they are complete and ready for review
    • Route materials for review and approval
    • Facilitate and manage logistics of meetings
    • Record changes and comments during meetings
    • Primary reviewer for final copy reflecting changes made during review
    • Ensure projects are completed on schedule following established procedures and timelines
    • Ensure consistency across functions for coordination of submissions, categorizing review types and prioritizing materials for review
    • Ensure active materials are reviewed annually

    EXPERIENCE AND QUALIFICATIONS:

    • Strong, open and transparent communication skills (verbal and written)
    • Strong computer skills – experience with MS Office and document management systems
    • Demonstrated excellence in project management and effectively managing multiple projects/priorities
    • Bachelor’s degree in business or biological sciences
    • 2+ years biotech or pharmaceutical industry experience required.


    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    135) Associate Director, Regulatory Affairs – Full Time Position (San Francisco Bay Area) B96RL

    DESCRIPTION:

    • Responsible for independent management of projects relating to investigation and marketing approval applications  
    • Provide regulatory support for chemistry, manufacturing and control, non-clinical animal studies, and human clinical studies of major projects from Phase 0 through Phase 4 commitments.  
    • Provide recommendations to project teams and management on regulatory strategy.  
    • Implement regulatory strategies and track progress towards regulatory goals.  
    • Facilitate interactions with regulatory bodies.  
    • Organize submissions to health authorities, including IND amendments, safety reports, pre-meeting packages, INDs, and NDA post-approval submissions.   
    • Develop regulatory strategy for products in order to optimize label and obtain shortest time to approval by regulatory agencies.
    • Primary responsibility for interaction with Regulatory Agencies 
    • Participate at the project team level, providing regulatory advice and opinion in the context of issues surrounding new product development and ongoing product support.
    • Initiate and update regulatory strategic plans for assigned projects.
    • Responsible for developing and maintaining an in-depth regulatory knowledge of the portfolio, including current and emerging global guidelines and regulations, relevant regulatory approaches and actions; and status of competitor products.
    • Ensure project team objectives and timelines are supported with regulatory deliverables.
    • Keep abreast of all pertinent laws, regulations and guidance as they pertain to regulatory strategies and submissions.
    • Manage the preparation of original INDs, CTAs, NDAs, MAAs and corresponding international registration packages; and amendments/supplements to these applications and responses to regulatory agency questions, and export applications.
    • Manage the preparation of health authority meeting packages and minutes of the meetings.
    • Review and approve protocols, reports, and documents used in regulatory submissions.
    • Facilitate the preparation of documents for electronic submissions.

    EXPERIENCE AND QUALIFICATIONS:

    • Specialized knowledge of regulatory activities including but not limited to submissions to health authorities, including IND amendments, safety reports, pre-meeting packages, INDs, and NDA post-approval submissions
    • Ability to effectively supervise regulatory technical staff.
    • 6+ years regulatory affairs experience, with a working knowledge of routine procedures associated with submissions preferred. 
    • Should have 8 to 10 years of experience in technical areas of the pharmaceutical industry that require interaction with regulatory authorities. 
    • MS or PhD in biological/chemical sciences or related field.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    136) Project Manager, Medical Affairs – Full Time Position (San Francisco Bay Area) HB109Y

    DESCRIPTION:

    • Responsible for the introduction and development of a project management culture for planning, organizing and implementing projects and initiatives with a focus on driving clinical initiatives into operations.  The role will expand over time to include other initiatives.
    • With direction from CMO, the Project Manager, leads the planning, coordinating and management of projects to achieve two major goals.
    • The main focus is on the development of timelines, milestones, risks and cost assessments.  Clinical expertise and assessment will be contributed by other project managers, clinical programs and clinical experts in other teams.  Will focus on the critical part of assessing the needs and risks across all divisions.
    • Screening and examining of new services to align with stakeholders organizations/integrated systems.  Such projects require the analysis of feasibility, costs, risks and benefits in order to make appropriate decisions.
    • Key person in the assessment and development of such projects.   They will also be in charge of developing a smooth implementation plan which will be seen through to the end until the project becomes a standard of care for the business.
    • Will serve as an interface from the medical clinical team to operations, IS and Finance leading critical collaboration on projects. 
    • This individual must display very strong leadership and team player skills.  Updates of the projects with interim and final reports are prepared for each project and presented on a regular basis to medical affairs and executive team.
    • Project issue identification and examination followed by regular status reporting.
    • Being responsible for all application business systems and services related to the project,
    • Executing the project plan and providing the required management and leadership to bring successful closure to the project.
    • Responsible for clearly defining problems by collecting complete data, establishing facts, and drawing logical conclusions.
    • Focus on the overall project objectives and obtaining consensus while facilitating process transformation where needed and navigating through challenging meetings and situations.
    • Management of the Project Timeline during development and execution.
    • Managing Issues across all stakeholders as they arise during project development and execution.
    • Conduct project status meetings as applicable including chairing appropriate committees.
    • Ensuring all project documentation is being done all along the way.
    • Close the project by validating acceptance/achieving metrics as defined.
    • Conduct appropriate closing activities including lessons learned, next phase planning.
    • Strategic and charismatic motivator to keep the project team informed, engaged, and motivated.
    • Understanding and interpreting project scope, gathering business requirements (if applicable), review of functional specifications, developing project plans and timelines, planning and conducting regular project meetings for assigned projects, resource coordination, and preparing and completing required project documentation.
    • Must be highly proactive, taking ownership of the project issues and challenges impacting the stakeholder groups, overcoming obstacles, and completing assigned tasks on time as per project timelines.
    • Responsible for regular update of the progress to senior management.
    • Performs intermediate level of business requirements analysis on assigned projects
    • Tracks and reports project-level success metrics, including issues tracking as needed
    • Coordinating multi-disciplinary teams and communicates priorities among the project team as needed
    • Ensure completion of project deliverables and tasks with adherence to established timelines
    • Analyze and resolve issues that have the potential to jeopardize the ability to meet agreed upon deliverables
    • Provide full and accurate project communication and messaging with the internal and external clients and vendors.
    • Manage day to day activities of multiple assigned projects including coordination of cross-functional teams.
    • Manage internal and external expectations on all project requirements and deliverables.
    • Identifies and drives resolution on assigned project issues impacting services.
    • Ability to lead project teams to achieve common goals.

    EXPERIENCE AND QUALIFICATIONS:

    • Project Management in successful companies – preferably in the healthcare environment.
    • MS Office including Excel, baseline statistics (Mean, SD, Median, Range, etc.), excellent communication, interpersonal and project management skills are required. 
    • Master’s degree in either Business Administration or Science or equivalent combination of training and experience.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    137) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

    DESCRIPTION:

    This hands-on position will lead the Clinical Quality Assurance program.  Will develop and improve the existing GCP-related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. Responsible for developing specific internal procedures, training of staff, and hosting FDA inspections.

    Job Responsibilities:
    • Develop GCP-related quality system SOPs in compliance with all applicable regulatory requirements.
    • Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
    • Oversee/conduct audits of investigator sites, clinical research organization (CRO) facilities and various clinical vendors.
    • Oversee/conduct audits of clinical study documents, which include investigator brochures, clinical protocols and study reports, case report forms and informed consents forms.
    • Oversee/conduct internal audits to ensure compliance with department guidelines and procedures, and Good Clinical Practice and ICH Guidelines.
    • Provide expert GCP QA advice to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best practices.
    • Support the administration of the company’s training program by conducting GCP training to internal departments and externally, if applicable.
    • Manage/conduct targeted training of investigators/site staff.
    • Report GCP deficiencies to QA management.
    • Assist clinical study teams in the development of CAPAs.
    • Coordinate responses to regulatory agency inspections.

    EXPERIENCE AND QUALIFICATIONS:

    • Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
    • Excellent verbal and written communication skills, able to lead cross-functional teams and independently, able to prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
    • Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
    • Experience working with clinical sites.
    • Experience in developing SOPs in for quality assurance and compliance.
    • Experience with clinical trials at all phases of development.
    • Experience with creating quality systems in a small company environment.
    • BS/BA degree and minimum 10 years of related experience; or MS/MA degree in related discipline and minimum 7 years of related experience.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    138) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

    DESCRIPTION:


    This hands-on position will lead the Clinical Quality Assurance program.  Will develop and improve the existing GCP-related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. Responsible for developing specific internal procedures, training of staff, and hosting FDA inspections.

    Job Responsibilities:
    • Develop GCP-related quality system SOPs in compliance with all applicable regulatory requirements.
    • Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
    • Oversee/conduct audits of investigator sites, clinical research organization (CRO) facilities and various clinical vendors.
    • Oversee/conduct audits of clinical study documents, which include investigator brochures, clinical protocols and study reports, case report forms and informed consents forms.
    • Oversee/conduct internal audits to ensure compliance with department guidelines and procedures, and Good Clinical Practice and ICH Guidelines.
    • Provide expert GCP QA advice to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best practices.
    • Support the administration of the company’s training program by conducting GCP training to internal departments and externally, if applicable.
    • Manage/conduct targeted training of investigators/site staff.
    • Report GCP deficiencies to QA management.
    • Assist clinical study teams in the development of CAPAs.
    • Coordinate responses to regulatory agency inspections.

    EXPERIENCE AND QUALIFICATIONS:

    • Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
    • Excellent verbal and written communication skills, able to lead cross-functional teams and independently, able to prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
    • Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
    • Experience working with clinical sites.
    • Experience in developing SOPs in for quality assurance and compliance.
    • Experience with clinical trials at all phases of development.
    • Experience with creating quality systems in a small company environment.
    • BS/BA degree and minimum 10 years of related experience; or MS/MA degree in related discipline and minimum 7 years of related experience.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    139) Consulting Ontologist – Contract (San Francisco Bay Area) FR103P

    DESCRIPTION:

    • Assist the ontology group in the development of large, high-quality knowledge base of biological concepts with a particular emphasis on the extension of the system to cover new biological concepts.
    • Focus of this position is on chemistry and drug content.
    • Represent and connect biological and chemical concepts
    • May be involved in quality control of modeled concepts

    EXPERIENCE AND QUALIFICATIONS:

    • Detail-oriented
    • Strong logic skills
    • Internet savvy
    • Available for training via phone/web conferences; position is off-site
    • Must maintain minimum level of productivity (currently corresponds to at least 10 hrs/week)
    • Must be legally able to accept consulting work in the US
    • Experience with public sources of information about biochemicals, such as PubChem
    • Experience with public sources of information about drugs, such as Drugs@FDA and ClinicalTrials.gov
    • PhD (or Masters with substantial research experience) in biochemistry or organic chemistry
    • No travel required

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    140) Lead CRA (in-house) – Full Time Position (San Francisco Bay Area) ZW104M

    DESCRIPTION:

    • Responsible for tasks that relate to the operations and management of clinical trials. 
    • Monitoring clinical studies of investigational and approved products. This may include qualification, initiation, interim monitoring, and close out site visits.
    • Acting as primary liaison between the study site staff and sponsor company.
    • Monitoring studies by reviewing and reporting to the sponsor on the following: site enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalities. 
    • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
    • Reviewing investigational product accountability, including discrepancy resolution.
    • Processing or overseeing transmission of study data to sponsor according to protocol-specified timelines.
    • Reviewing data queries and listings, and working with the study site staff to resolve data discrepancies.
    • Overseeing the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples.
    • Maintaining consistent contact with the study site staff, including investigators, coordinators, client personnel, and other individuals involved in the clinical study.
    • Visit report writing and site correspondence.
    • Training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
    • Managing the preparation, collection and maintenance of trial regulatory documents. 
    • Maintaining complete and accurate study files, and reviewing files to ensure all appropriate documentation is present.
    • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites. 
    • Managing investigational product ordering, packaging, labeling and ongoing inventory.
    • Managing the reporting of serious adverse events. 
    • Developing study-related documents such as: protocols, case report forms, informed consent forms, study binders, standard operating procedures, study guidelines, study management/tracking tools, and monitoring plans.
    • Preparing contracts with investigators/hospitals, and negotiating budgets and payment schedules. 
    • Planning, preparing for, and giving presentations at investigator meetings. 
    • Development and management of study timelines.
    • Assisting with medical writing and regulatory submissions, such as interim, final study, and annual progress reports. Developing or updating Investigational Product Brochures. Preparing documentation for regulatory submissions (IND, NDA, BLA, IDE, PMA).
    • Visit report writing and site correspondence.
    • Interacting with project manager (sponsor or other) through formal and informal communications, including providing updates, identifying issues, sharing of information and instructions.
    • Managing the resource requirements of the project.
    • Supervision and guidance of CRAs, CR Assistants, and external CROs. Conduct of co-monitoring, training and audit visits. Creation of visit report templates. Review of completed visit reports.
    • Managing all aspects of the implementation of a clinical study. 
    • Interdepartmental liaison working with regulatory, data management, bSelection and management of outside vendors, such as CROs, DM groups, investigational product packaging, and central laboratories.

    EXPERIENCE AND QUALIFICATIONS:


    • Detail oriented. 
    • Excellent organizational skills, strong interpersonal and communications skills, and strong problem solving skills.
    • Familiarity with medical and pharmaceutical industry, and related terminology and practices. 
    • Extensive knowledge of FDA regulations and their practical implementation.
    • Willingness to travel.
    • Computer proficiency in Microsoft Word, Excel, and PowerPoint
    • Oncology, vaccines or dermatology experience a plus
    • RN or BS degree in biological sciences or related field or equivalent combination of education and experience: 4 or more years successful CRA experience

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    141) Scientist – Contract (Maryland) 73X8089

    DESCRIPTION:

    • Make detailed observations and analyze data. 
    • Prepare technical summaries and protocols for internal use.
    • Conduct pre-designed scientific or engineering experiments using laboratory equipment and calculations.
    • Plan the use of equipment, materials and own time.
    • Assist in lab procurement, calibration or maintenance.
    • Make detailed observations and basic data analysis.
    • Maintain complete and thorough lab notebook and training file.
    • Advise supervisor of factors that may affect quality, accuracy, timeliness and usefulness of data. 
    • Troubleshoot experiments with assistance from supervisor.
    • Comply with all company safety regulations and procedures.
    • Report non-compliance and may serve as team lead.
    • With supervisor’s guidance, become familiar with literature directly associated with assigned project and transmit information gathered to other members of the scientific team.
    • May be required to perform other related duties as required and/or assigned.

    EXPERIENCE AND QUALIFICATIONS:

    • Position exercises judgment within defined procedures and practices to determine appropriate action. 
    • Normally receives general instruction on routine work, detailed instruction on new assignments. 
    • Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity. 
    • Works on problems where analysis of situation or data requires a review of identifiable factors. 
    • Must have manufacturing experience.
    • Accuracy is required in performing all functions of this position as mistakes in work could cause substantial interpretive errors.
    • Bachelor's degree in Biology/Chemistry/Biochemistry or other related discipline or the equivalent knowledge and experience. 
    • 0-2 yrs experience. 
    • Any GMP or clean room experience is a plus but not required.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    142) Commercial Compliance Manager/ Sr Manager – Full Time Position (San Francisco Bay Area) PX100J

    DESCRIPTION:

    • Interface with internal cross-functional partners, within Commercial, IT and other company functions
    • Track, monitor, manage and report company's aggregate spend with Healthcare Professionals (HCPs) and organizations, as well as play an active role in the development of associated business processes, systems and tools.  
    • Direct IT and conduct data analysis to distill useful information that helps drive business decisions. 
    • Work with manager in developing training/development programs and initiatives, preparing and delivering senior management presentations on strategic or complex issues and leading strategic projects.  
    • Stay abreast of relevant laws and regulations that affect organizational spending with HCPs and healthcare related organizations; and play an active role in educating and keeping others internally abreast regarding such laws and regulations
    • Play a proactive role in helping identify, recommend, develop and implement departmental policies, procedures, systems, methodologies, templates and other tools to effectively and efficiently track, monitor, measure and report on company's aggregate spend with HCPs
    • Acts as a lead subject matter expert on data sources, analytical methodologies, and reporting requirements, as well as related business processes, systems, templates and other tools
    • Keeps internal business partners and stakeholders apprised of evolving legislation and regulations regarding spending and compliance
    • As appropriate, conducts internal education/training sessions with internal business partners and/or other stakeholders
    • Works with manager and other team members to regularly assess analytical methodologies and practices, data sources, data monitoring and mining systems, other business processes, relevant systems and tools.
    • Collaborate with various cross-functional groups to assess broader business intelligence needs
    • Integrate design across multiple company databases and other information platforms for streamlined and accurate data
    • Develop Standard Operating Procedures (SOPs) and/or Department Operating Procedures (DOPs)
    • Lead special projects, as assigned, potentially working with a host of internal business partners or stakeholders
    • May act as project lead for planning and development of systems. Conducts requirements' gathering, may lead planning and development sessions, and project manage systems updates or other enhancements, which may involve regular interface and liaison with Information Technology
    • Develops and disseminates a calendar of regular reporting required to support spending compliance
    • Attends internal business partner/stakeholder meetings to stay abreast of internal business plans, objectives and activities associated with transparency requirements. 

    EXPERIENCE AND QUALIFICATIONS:

    • Some previous biopharmaceutical consulting experience is preferred
    • Must demonstrate knowledge of, or the aptitude to learn, the legal and regulatory environment, as it relates to spending in the pharmaceutical/biotechnology industry.  Previous experience with compliance/ a highly regulated environment is required.
    • Excellent Microsoft Excel-based modeling skills 
    • Excellent presentation skills and ability to present analytical information ito senior management in order to facilitate decision making
    • Familiarity with accounting and Enterprise Resource Planning (ERP) systems and experience with object-oriented query tools such as Brio, Business Objects and SAP BW is a plus (not required)
    • Proven track record of meeting or exceeding objectives and goals
    • Willingness to Travel – Occasionally
    • Bachelors Degree (life sciences, finance/accounting, information systems or related discipline is a plus)
    • MBA, JD, CPA, MHA, or other related graduate-level degree is preferred
    • 3 or more years’ related experience in healthcare, medical education and/or market research
    • 3 or more years in analytical-oriented or compliance positions, such as sales operations, finance, quantitative market

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    143) Clinical Scientist – Full Time Position (San Francisco Bay Area) TM111X

    DESCRIPTION:

    • Will report to the Senior Director, Clinical Development and assist in medical monitoring duties, communications with sites, clinical operations team members, SOT members, and contractors, and clinical trial data filing and medical management of trials.
    • With Senior Director, provide  medical decision-making for management of subjects in clinical trials, including decision-making regarding subject safety  
    • Writing of protocol sections, amendments, clinical study reports and narratives, and other communications including the Annual Report and the Investigator’s brochure
    • Prepare presentations of clinical study updates to internal staff and scientific communications to external groups, including professional societies and patient advocacy groups
    • Working under the Senior Director’s direction, conduct literature searches, safety and efficacy data reconciliation, checking, analysis, interpretation, and reporting
    • Provide medical direction and strategic clinical trial input to the clinical operations team

    EXPERIENCE AND QUALIFICATIONS:


    • Thorough knowledge and understanding of the pulmonary medicine therapeutic area
    • Knowledge of clinical trial design, data interpretation and analysis
    • Ability to analyze, interpret, and report clinical trial findings
    • Effective oral and written communication skills
    • Advanced skills in Word, Excel, and PowerPoint
    • Strong statistical analysis background is desirable
    • Strong interpersonal skills and ability to work effectively with senior level as well as MDS, project teams, Quality Control, Data Management, Safety, Biometrics, and Clinical Operations staff
    • Medical Doctor Degree, or equivalent, with at least two years’ industry experience performing Clinical Scientist type activities described above
    • A PhD or RN with at least 8 years’ equivalent experience may also be considered

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    144) Document Control Specialist – Contract - 6 Months (San Francisco Bay Area) T96RB

    DESCRIPTION:

    • Support QA Document Control PAI (Pre-Approval Inspection) readiness projects. 
    • Provide support for project to return Department Managed Documents to the Document Control System – bring all the outlying dept managed documents into DC. This will include a DCR review/approval process for each document, reformatting, and SharePoint upload
    • Provide support to the new archive Log process –support a new system to manage documents that are not required to be controlled, but that are important documents that should be kept secure and easily retrievable.
    • Retrieve PAI related documents from DataSafe  – retrieve archived documents, review them and return to the onsite files that are PAI related.  Then re-index and send the unneeded documents back to DataSafe.
    • New Document Vault organization – Complete the move of documents into the new vault. Reorganize the files , create a complete index of all documents in the vault, (both DCR controlled and others such as Batch records training files, and CMO supplier documents 

    EXPERIENCE AND QUALIFICATIONS:

    • Must have extensive experience using Adobe Acrobat Professional, MS Access, Excel, and Word
    • Must have experience with SharePoint, Visio, Web-based document indexing and viewing applications
    • General knowledge of electronic documentation systems, data retrieval, and electronic file formats
    • Ability to demonstrate initiative. 
    • Ability to organize work in an efficient manner and work well under time constraints
    • Ability to multi-task and handle changing priorities as needed in a fast paced environment
    • 4 years experience with documentation practices in an FDA-regulated environment
    • 2 year experience creating, using and administering electronic document management tools
    • High school diploma with 4 years related experience and/or training or equivalent combination of education and experience.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    145) Senior Manager, Bioinformatics – Full Time Position (Midwest) B73FN

    DESCRIPTION:

    The purpose of this position is to lead a bioinformatics team that focuses on two areas:  (1) develop and maintain the informatics pipelines and algorithms that comprise our knowledge base, and (2) provide project-based bioinformatics support to the Pharma and Clinical Diagnostic Services business to enable the application of cancer knowledge base and bioinformatics methods.
    This team mission is to develop and continuously improve methods for identifying the driver aberrations in cancer through the systematic analysis of high-throughput molecular profiling data.

    RESPONSIBILITIES

    • Manage a bioinformatics team that provides: Algorithm and method development in support of the continuous growth and improvement of core compendium of genomic data and cancer knowledge. and Project based bioinformatics support to our Pharma Services and Clinical Diagnostics businesses
    • Organizing and leading the Bioinformatics team to ensure a robust and scalable end to end working bioinformatics pipeline and, working with customers and other teams, provide custom bioinformatics analysis and solutions.
    • Provide strategic direction and guidance to Bioinformaticians in their daily analysis and product development efforts as well as their individual career development and growth.
    • Critical assessment of experimental data to identify patterns that improve content usability to answer core questions
    • Guide team in matrixed environment. Ability to allocate development resources to staff projects appropriately in that environment.
    • Provide accurate scoping and estimation of development efforts for projects based on product requirements and a solid grasp of the relevant bioinformatics tools.
    • Investigate, create and develop new methods and technologies for project advancement.
    • Coordination with other R&D functions as well as Product Management and Marketing to identify critical product development features to prioritize for future releases
    • Communication and coordination with leadership to promote effective systems development.
    • Maintain high level of professional expertise through familiarity with current scientific literature, competing technologies and/or products and attendance of scientific seminars and meetings.
    • Communicates the significance of recent scientific and technology developments to peer group.
    • Collaborate with sequencing teams and clinical researchers to qualify product performance.
    • When needed, select external vendors and consultants and manage engagements.
    • Enthusiasm to collaborate with other departments as a technical consultant.
    • Serve as internal technical expert

    EXPERIENCE AND QUALIFICATIONS:

    • Expertise in both bioinformatics and genomics applications is required.
    • Proven understanding and experience in the fields of genomics, experimental data processing, high-throughput data analysis, and genomic databases. 
    • Understanding of basic biology and cancer biology a must.
    • Firm grasp of univariate statistical analysis fundamentals necessary. 
    • Experience with multivariate statistics or statistical modeling a plus.
    • Candidates should have knowledge of leading NGS processing techniques for the quantification of gene expression and copy number, and the identification of somatic mutations, gene fusions, and genomic rearrangements.  Direct experience processing NGS data is a plus.  Candidates should be familiar with the limitations of the various NGS platforms and informatic pipelines, so that data are appropriately integrated into analyses.
    • Strong computational skills, particularly in data parsing, cleansing, data modeling, analysis, and database design and implementation.
    • Solid knowledge of unix/linux. Experience with cluster computing a plus.
    • Previous bioinformatics and scientific programming experience necessary; experience with Spotfire, Pipeline Pilot, R, SQL, and NGS a plus.
    • Ability to review, synthesize, and present scientific data and methods.
    • Good written and verbal communication skills.
    • Inspires, motivates and collaborates with others.
    • Anticipates needs and problems while creating solutions.
    • 7 or more years of post-graduate work experience
    • PhD in computer science, computational biology, biostatistics, bioinformatics, or similar (MS acceptable for the candidate with the right experience)

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    146) Senior Manager/Associate Director, Regulatory Affairs – Full Time Position (San Francisco Bay Area) XM96F

    DESCRIPTION:

    • Responsible for management of projects relating to investigation and marketing approval applications in the U.S. and ex-U.S.  
    • Provide regulatory support for nonclinical and human clinical studies of major projects from Phase 0 through Phase 4 commitments.  
    • Attend and provide regulatory support to other departments, project teams, and committees.  
    • Organize/manage submissions to health authorities, including IND/IND amendments, CTAs, safety reports, pre-meeting packages, and NDA post-approval submissions.    
    • Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (INDs, MFs, IMPDs, CTXs, etc.), and prepare for the filing of subsequent licensing applications (NDA, MAA, e-CTD, etc.).  
    • Coordinate multiple submissions and projects effectively
    • Execute, independently or with very limited guidance and supervision, product development and regulatory strategies regarding submissions and compliance issues
    • Participate at the project team level, providing regulatory advice and opinion in the context of issues surrounding new product development and ongoing product support.
    • Initiate and update regulatory strategic plans for assigned projects.
    • Responsible for developing and maintaining an in-depth regulatory knowledge of the portfolio, including current and emerging global guidelines and regulations, relevant regulatory approaches and actions; and status of competitor products.
    • Ensure project team objectives and timelines are supported with regulatory deliverables.
    • Keep abreast of all pertinent laws, regulations and guidance as they pertain to regulatory strategies and submissions.
    • Manage the preparation of original INDs, CTAs, NDAs, MAAs and corresponding international registration packages; and amendments/supplements to these applications and responses to regulatory agency questions, and export applications.
    • Manage the preparation of health authority meeting packages and minutes of the meetings.
    • Review and approve protocols, reports, and documents used in regulatory submissions.
    • Facilitate the preparation of documents for electronic submissions.

    EXPERIENCE AND QUALIFICATIONS:

    • Specialized knowledge of regulatory activities including but not limited to submissions to health authorities, including IND amendments, safety reports, pre-meeting packages, INDs, and NDA post-approval submissions
    • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
    • Knowledge of GMPs, GLPs, and GCPs
    • Well organized, detail oriented, effective written and oral communication skills, and good grammatical skills
    • Ability to guide, train, and supervise personnel; oversees the work of direct reports to ensure on-time, on-target and within-budget results
    • BS in biological/chemical sciences or related field.
    • 5+ years regulatory affairs experience, with a working knowledge of routine procedures associated with submissions preferred.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    147) Statistician – Contract (New Jersey) 8014

    DESCRIPTION:

    • Under the supervision of the project lead statistician, responsible for statistical deliverables and statistical support for multiple oncology studies  
    • The deliverables include statistical analysis plans (SAPs), programming specifications, data review documents, statistical analyses for final and interim analyses, and final study reports. 
    • The involved activities include attending clinical team meetings, interacting with study team members, working and providing statistical input to programmers, and providing periodic updates to project lead statistician on the study timeline and activities. 
    • Needs to understand clinical trial data sets and quickly learn the principles of de-identification and perform quality control of process. 

    EXPERIENCE AND QUALIFICATIONS:

    • Must have clinical trial experience, knowledge of STDM data
    • SAS programming is preferred
    • Good communication skills to coordinate the projects with various of departments
    • Able to learn de-identification principles and to understand a study design and data structure quickly
    • Pay attention to details. 
    • Past experience of oncology trials is desired.
    • 3-5 years of pharmaceutical industry experience
    • A Master Degree of statistics or related field is preferable

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    148) Clinical Trial Manager – Full Time Position (San Francisco Bay Area) T96NH

    DESCRIPTION:

    • Leads activities associated with LOI evaluation and protocol review.  
    • Coordinates the review and communication comments on studies.  
    • In collaboration with the Director, oversees team members, including oversight of vendors.  
    • Coordinates the training of staff involved in programs.  
    • Provides training to Medical Affairs staff and performs performance appraisals of direct reports.
    • Responsible for the review and finalization of project and study-related documents including: protocols, informed consent forms, contracts, budgets, safety reporting, IND Annual updates and review of proposed clinical trial presentations and publications, as required.
    • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to Director
    • Coordinate and manage Investigational product supply, including overall accountability and reconciliation
    • Responsible for  the preparation of study budgets and timelines
    • Manage project timelines and correlative studies to meet goals
    • Manage contracts, budgets and payment processes for all vendors including clinical trial sites
    • Monitor and track clinical trial progress and provide status update reports
    • Manage vendors
    • Responsible for selection of staff and coordinating training, including documentation
    • Provide guidance on site issues
    • Lead, with minimal supervision, the planning of meetings and presentations, as required
    • Lead the review of clinical data as needed
    • Represent Medical Affairs on the Review Teams
    • Partner with other research and development groups to achieve deliverables
    • Monitoring of sites for adherence to protocol and GCP as required
    • Travel as required to carry out responsibilities
    • Identify and escalate site, vendor and study related issues to director, as appropriate
    • Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
    • Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
    • Perform other duties as assigned

    EXPERIENCE AND QUALIFICATIONS:

    • Must have demonstrated expertise in relevant clinical trial activities
    • Ability to exercise independent judgment within generally defined practices and policies that lead to processes for achieving results
    • Good organization and planning skills
    • Strong interpersonal skills and communication skills (both written and oral)
    • Ability to problem solve and delegate appropriate tasks to subordinates
    • Knowledge of ICH/GCP guidelines and FDA regulations
    • Strong leadership skills, self-motivated, adaptable to a dynamic environment
    • Able to collaborate effectively with study sites, cross-functional team members, and external partners
    • Proficiency in MS Word, Excel and PowerPoint
    • Able and willing to travel approximately 10-20%  
    • 7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience)
    • Experience in oncology preferred
    • Experience in global trials preferred 
    • BA/BS/MS in a scientific discipline

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    149) Senior Clinical Research Associate / Clinical Trial Manager – Full Time Position (San Francisco Bay Area) MJ96F

    DESCRIPTION:

    • Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
    • Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
    • Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
    • Develop study budget and timelines
    • Prepare regulatory documents and submissions
    • Execute project specific training for internal and external staff
    • Maintain Trial Master File
    • Manage Investigational Product (IP)
    • Manage safety reporting
    • Procure and manage contracts with CROs, study vendors and investigative sites
    • Provide oversight of CROs, independent field monitors and other clinical vendors
    • Review monitoring trip reports and track resolution of all action items
    • Co-monitor at investigative sites to evaluate study site and field monitor performance
    • Collaborate with medical experts, clinical study sites, and clinical study vendors
    • Performs  in-house review of clinical database listings for completeness and accuracy
    • Develops clinical study reports

    EXPERIENCE AND QUALIFICATIONS:

    • Excellent verbal and written communication skills
    • Attention to detail
    • Able to organize, manage and set priorities for multiple tasks
    • Strong leadership skills, self-motivated, adaptable to a dynamic environment
    • Able to collaborate effectively with the study team, cross-functional team members, and external partners
    • Knowledge of ICH/GCP and FDA regulations
    • Proficiency in MS Word, Excel and PowerPoint
    • Able and willing to travel approximately 25-30%  
    • 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience) 
    • Experience in oncology preferred
    • Experience in global trials preferred
    • Experience with Electronic Data Capture systems preferred 
    • BS/BA degree in a life science, RN, or related field

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    150) Regulatory Consultant – Contract (San Francisco Bay Area) P108DR

    DESCRIPTION:

    • Support regulatory affairs activities
    • Support  global clinical trials applications working directly with the CRE

    EXPERIENCE AND QUALIFICATIONS:

    • Deep understanding of FDA and rest of world regulations
    • Highly experienced and can work independently; Minimum previous title of Senior Manager Regulatory Affairs in a pharmaceutical or biotechnology company; Higher level preferred
    • On-site work at least part of the time
    • Minimum education at the Bachelors degree level

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    151) Sr. Staff Scientist, Translational Medicine – Full Time (Midwest) M73QL

    DESCRIPTION:

    • Provide leadership in the application of cancer data sciences to translational medicine and diagnostics opportunities. 
    • Will be expected to exhibit scientific leadership of cancer genome data sciences.
    • Provide scientific review, and ensure that results intended for internal and external customers are presented clearly and effectively.
    • Strong scientific and technical leadership is expected, along with ability to foster collaboration and innovation from the Translational Medicine team.
    • Partner with bioinformatics colleagues to develop and assess bioinformatics strategies.
    • Contribute to the development of innovative methods, software platforms, and infrastructure.
    • Support and/or lead the development of scientific presentations for scientific conferences and publications.
    • May be required to perform other related duties as required and/or assigned. 

    EXPERIENCE AND QUALIFICATIONS:

    • Requires a minimum of  5 years of relevant post-graduate experience in a cancer focused translational medicine related field. Industry experience is a plus.
    • Requires demonstrated expertise and experience working with cancer genomics data, along with a solid understanding of tumor biology and oncogenic signaling pathways.
    • Proven scientific excellence exemplified by lead author publications in high impact trade journals and/or significant contributions to industry programs.
    • Ability to work independently and collaboratively.
    • Requires ability to communicate effectively in spoken and written English language.
    • Prior work experience in industry or tenure-track academic position preferred.
    • Solid understanding of common statistical approaches used with genomic data preferred. 
    • PhD and/or MD in relevant field required.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    152) Staff Scientist, Bioinformatics – Full Time (Midwest) W73BH

    DESCRIPTION:

    • Seeking individuals with expertise in bioinformatics and an understanding of the cancer genome to identify cancer driver aberrations and to associate those genetic events with potential therapeutic strategies.  
    • Work collaboratively in a matrix environment to develop data analysis strategies to address key questions about cancer for our internal and external customers.  
    • Applications include diagnostics, target and biomarker discovery, indication selection, and clinical development strategies.
    • Collaborate with Medical Sciences Informatics (MSI) colleagues to understand our customer’s questions about cancer, patients, and drugs, and develop data analysis strategies and plans to answer them.
    • Implement bioinformatics data integration and analysis pipelines in Pipeline Pilot and/or scripting languages, drawing on MSI's large collection of high-throughput genomic data and sample annotations.
    • Develop visualization environments in Spotfire to enable scientists to explore the data and answer questions.
    • Written and verbal presentation of results and methods.
    • May be required to perform other related duties as required and/or assigned.

    EXPERIENCE AND QUALIFICATIONS:

    • Proven understanding and experience in the fields of genomics, experimental data processing, high-throughput data analysis, and genomic databases. Understanding of basic biology and cancer biology a must.
    • Firm grasp of univariate statistical analysis fundamentals necessary. Experience with multivariate statistics or statistical modeling a plus.
    • Candidates should have knowledge of leading NGS processing techniques for the quantification of gene expression and copy number, and the identification of somatic mutations, gene fusions, and genomic rearrangements.  Direct experience processing NGS data is a plus.  Candidates should be familiar with the limitations of the various NGS platforms and informatic pipelines, so that data are appropriately integrated into analyses.
    • Strong computational skills, particularly in data parsing, cleansing, data modeling, analysis, and database design and implementation.
    • Solid knowledge of unix/linux. Experience with cluster computing a plus.
    • Previous bioinformatics and scientific programming experience necessary; experience with Spotfire, Pipeline Pilot, R, SQL, and NGS a plus.
    • Ability to review, synthesize, and present scientific data and methods.
    • Good written and verbal communication skills.
    • Inspires, motivates and collaborates with others.
    • Anticipates needs and problems while creating solutions.
    • 5 years of post-graduate work experience
    • PhD in computer science, computational biology, biostatistics, bioinformatics, or similar (MS acceptable for the candidate with the right experience)

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    153) Scientist III, Bioinformatics – Full Time Position (Midwest) P73NA

    DESCRIPTION:

    • Collaborate with scientists to understand customer’s questions about cancer, patients, and drugs, and to develop data analysis strategies and plans to answer them.
    • Collaborate with colleagues to understand our customer’s questions about cancer, patients, and drugs, and develop data analysis strategies and plans to answer them. 
    • Implement bioinformatics data integration and analysis pipelines in Pipeline Pilot and/or scripting languages, drawing on large collection of high-throughput genomic data and sample annotations. 
    • Develop visualization environments in Spotfire to enable scientists to explore the data and answer questions. 
    • Written and verbal presentation of results and methods. 
    • May be required to perform other related duties as required and/or assigned. 

    EXPERIENCE AND QUALIFICATIONS:

    • Proven understanding and experience in the fields of genomics, experimental data processing, high-throughput data analysis, and genomic databases. 
    • Understanding of basic biology and cancer biology a must.
    • Firm grasp of univariate statistical analysis fundamentals necessary.  
    • Experience with multivariate statistics or statistical modeling a plus.
    • Strong computational skills, particularly in data parsing, cleansing, data modeling, analysis, and database design and implementation. 
    • Solid knowledge of unix/linux.  
    • Experience with cluster computing a plus. 
    • Ability to review, synthesize, and present scientific data and methods. 
    • Outstanding written and verbal communication skills. 
    • Previous bioinformatics and scientific programming experience necessary; experience with Spotfire, Pipeline Pilot, R, SQL, and NGS a plus. 
    • Scientific experience in cancer study and/or research a plus. 
    • Pharmaceutical experience and lead author publications are highly valued. 
    • Inspires, motivates and collaborates with others. 
    • Anticipates needs and problems while creating solutions.
    • Requires a Masters and/or PhD along with minimum 5 years post-graduate work experience in related field

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    154) CMC Regulatory Associate Director / Director – Full Time Position (San Francisco Bay Area) SM80Y

    DESCRIPTION:

    • Acts as the CMC regulatory lead by providing regulatory strategy and support to global development teams and facilitating all regulatory filings relating to CMC.
    • Executes CMC regulatory strategy.
    • Represents RA CMC at project team meetings and coordinates regulatory  workflow between departments as well as CROs.
    • Coordinates, writes, compiles CMC  document packages and investigational drug shipment related activities for  drug manufacturing   according to regulations/guidelines and company SOPs. 
    • Regulatory lead for module 3 of upcoming eCTD filings.
    • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
    • Regulatory Lead for interactions with regulatory authorities on CMC issues. 
    • Participates in Regulatory Affairs initiatives to improve company standards and systems.

    EXPERIENCE AND QUALIFICATIONS:

    • Ability to manage multiple and varied tasks in a fast-moving environment.
    • Good record-keeping skills. 
    • Proficient with computer (MS Office) and internet skills. 
    • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
    • Proven ability to communicate with executive management,  cross-functional team members and operational staff.
    • Flexible attitude with respect to work assignments, and new learning.
    • 3+ years relevant regulatory CMC experience.
    • BS and advanced degree in life sciences (MS, PhD or PharmD or equivalent).

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    155) Senior Manager / Associate Director, Regulatory Affairs – Full Time Position (San Francisco Bay Area) XV80J

    DESCRIPTION:


    • Lead teams on the preparation, review and finalization of annual reports.
    • Review, provide comments on, and prepare documents for submission to FDA and international regulatory authorities including protocols, investigator brochures, nonclinical and CMC amendments, and other regulatory documents.
    • Assist teams with the development, review, and finalization of briefing documents to FDA or health authorities, conduct meeting rehearsals, and participate in regulatory meetings.
    • Function as the primary contact with FDA and international regulatory authorities.
    • Provide regulatory guidance and strategy to assigned project teams
    • Lead working groups responsible for the development of regulatory submissions; interact with other team members to ensure timely preparation and receipt of information required for regulatory submissions.
    • For ex-US submissions to Thailand, Singapore, Hong Kong, or other ASEAN countries, lead and prepare submissions including CTCs, CTA, amendments and notifications.
    • Understand and identify potential regulatory risks and implications for ongoing and new projects, be proactive in identifying solutions to mitigating the risks and work effectively with team members and senior management to resolve them.

    EXPERIENCE AND QUALIFICATIONS:


    • Thorough understanding of current and evolving FDA, ICH and other appropriate regulations and guidance.
    • Experience with the preparation of INDs and amendments, and NDAs/BLAs; experience with submissions in CTD format preferred.
    • Leadership and management skills with the ability to manage simultaneous priorities and changing deadlines.
    • Excellent oral and written communication skills.
    • Excellent planning, organizational and prioritizing skills.
    • Proficiency in the use of MS Word, PowerPoint; experience with Adobe Acrobat Professional; experience with electronic publishing systems.
    • Scientific background (minimum BS degree or equivalent in the life sciences) with at least five years experience in regulatory affairs; experience with biological products preferred.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    156) Senior / Principal Medical Writer – Full Time Position (San Francisco Bay Area) T80BR

    DESCRIPTION:

    Responsible for writing, editing, and/or reviewing clinical documents including, but not limited to, clinical study reports, investigator’s brochures, protocols, and integrated regulatory summary documents. Creates documents that effectively and clearly convey scientific data, ensuring that such documents comply with regulatory guidelines in terms of content, structure, and style. Additional responsibilities include the following:

    • Write high-quality clinical documents that support company goals and objectives.
    • Understand the key components/messages for regulatory submissions as embodied in FDA and ICH guidelines.
    • Identify the customers for each document, and formulate and convey key messages clearly and concisely for those customers.
    • Keep current with therapeutic area(s) relevant to assigned projects.
    • Use appropriate company stylistic conventions.
    • Keep up-to-date on the software needed for this position.

    EXPERIENCE AND QUALIFICATIONS:


    • Knowledge of, or aptitude for understanding, medicine; familiarity with the drug development process and regulatory documentation.
    • Ability to gather and synthesize large amounts of data.
    • Demonstrated ability to write clear, concise, and effective drug development documents, including the ability to turn data into visuals that convey the key messages and to communicate complex information effectively and accurately.
    • Understanding the role of various documents relevant to drug development in an international environment.
    • Good team player; excellent written and verbal communication skills, and the ability to work well with others.
    • Proven document planning and project management skills.
    • Ability to meet timelines without compromising document quality.
    • Ability to communicate with professionals from many functional disciplines and to work across teams (often remotely).
    • Ability to ensure consistency within and across documents to avoid confusion.
    • Competency in relevant software applications.
    • 5 – 8 + years of industry experience as a pharmaceutical medical writer; an undergraduate degree in a scientific discipline is preferred; an advanced scientific degree is a plus.
    • Mandarin technical writing skills is a plus.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    157) Associate Director, Clinical Data Management – Full Time Position (San Francisco Bay Area) XT96G

    DESCRIPTION:

    • Responsible for the management of the data management group staff and deliverables. 
    • The ideal candidate will build and enforce the appropriate standards in the department for Phase 3 ready. 
    • Responsible for managing CROs and other outside vendors as appropriate. 
    • Act as a liaison between Data Management and Clinical staff.
    • Supervise and provide technical support to the members of the data management department in all activities related to data management.
    • Ensure the data management activities (CRO) adherence to standard and policies that are appropriate and applicable.
    • Direct interaction with functional departments, including Clinical, Regulatory, Safety, and Quality Assurance
    • Ensure data integrity across department following Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)
    • Manage appropriate revision to SOP and policies related to DM and consistent with other department. 
    • Direct supervision all staff in DM department
    • Oversees the work of direct reports to ensure on-time, on-target and within-budget results
    • Provides ongoing coaching, guidance and feedback to ensure direct reports are successful in their work, as well as have the necessary and timely access to information and other resources
    • Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports
    • Provides formal performance reviews and career development planning for all direct reports
    • Complies with all company HR policies and procedures, as well as state/federal employment-related laws

    EXPERIENCE AND QUALIFICATIONS:

    • Experience working with Oncology trials highly desirable.
    • Phase 3 experience is must, NDA experience is highly desired
    • Strong communication skills, both written and oral
    • 8+ years of Priori management experience in DM
    • Strong computer skills including technical aspects
    • Ability to analyze complex problems/situations requiring in-depth evaluation
    • Ability to use judgment based upon standards and policies to solve problems, meet timelines and provide alternative approaches
    • BS or BA degree in science/computer related field
    • 15+ years clinical data management experience in pharmaceutical/biotech industry, including EDC.

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    158) Senior Data Manager – Full Time Position (San Francisco Bay Area) GL85B

    DESCRIPTION:

    • Responsible for leading all activities of data management for clinical trials from start up to close out. 
    • Work with internal development colleagues and external clients to ensure delivery to time, quality and cost expectations.
    • Ensure that management’s clinical development objectives are met with regards to Data Management activities
    • Provide operational leadership to the direction, planning, execution, collection and interpretation of all clinical data to the highest quality standards
    • Report status of clinical data management activities to project teams and management
    • Involved in data preparation for reporting clinical study results for regulatory filings, publications, presentations
    • Conduct clinical data management activities using OmniComm’s Trial Master® and Oracle’s Clintrial® Data Management Systems
    • Develop and implement data management standard operating procedures
    • Create written data management plans
    • Design database structures and case report forms consistent with CDISC and CDASH initiatives
    • Manage group of junior data management personnel
    • Work with third-party vendors to develop data transfer specifications
    • Responsible for directing, managing and training CRO/internal staff as appropriate
    • Oversees the data management work and performs day-to-day data management activities. These include resources planning, developing and implementing standard data management procedures, training and supervising junior data management personnel, performing day-to-day data management activities according to ICH guidelines, regulatory requirements and the company’s standard operating procedures. 

    EXPERIENCE AND QUALIFICATIONS:


    • Advanced proficiency in core data management activities (e.g., case report form design, data edit specifications and data validation, creation of data management plans, expert use of adverse events and concomitant medication coding dictionaries, attention to detail and data quality)
    • Excellent communication skills and ability to direct others work efforts
    • Strong track record of leading clinical data management activities 
    • Undergraduate or higher degree; at least five years of experience in clinical trial data management in a pharmaceutical, biotech or CRO setting 
    • Bachelors with 5-8 years experience in pharmaceutical / biotech industry

    To apply for a position send your resume to Jobs@JGBBioPharma.com

    Back to Top

    linebreak

    159) IT Technical Writer – 6 month contract (San Jose Area) N96GB

    DESCRIPTION:

    • Core document areas are ERP implementation, SOX documentation, CRM/Salesforce/Veeva, and General IT controls
    • Types of documents – requirement specifications, design specifications, test strategy, test plans, i.e. IT software development specification documents




        EXPERIENCE AND QUALIFICATIONS:

        • Need deep expertise in the following software:  Word, Excel, Visio, and PowerPoint
        • Previous experience writing and editing IT software development documents
        • Work on site one day a week telecommute is OK.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        160) Sr. Medical Writer – Full Time Position (San Francisco Bay Area) JN85P

        DESCRIPTION:

        • Responsible to independently develop, write, and edit documents for clinical development as well as technical and/or scientific publications.  
        • Work closely with internal clinical development team members as well as external collaborators, such as KOLs and external vendors.  
        • The scope of documents range from pre IND through NDA.
        • Provide broad medical writing and project management support for programs and efforts of the Clinical Development group.
        • Able to develop documents from scratch.  Examples of documents include but are not limited to briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, Investigator’s brochure, clinical protocols and protocol amendments, model informed consents, interim and final clinical study reports, INDs, patient narratives, and other documents that support Clinical Development
        • Author, co-author, and edit publications (manuscripts, review articles, abstracts, poster and presentations).
        • Perform literature searches/reviews as necessary to obtain background information and training for document development.
        • Work with document templates and support eCTD document submissions.
        • Facilitate review of materials/documents to enable timely finalization of documents.
        • Build agreement cross-functionally on timelines and document management to ensure efficient document finalization.
        • Assist with the development and implementation of SOPs.

        EXPERIENCE AND QUALIFICATIONS:

        • PhD (required) with 8 - 10 years experience writing scientific or technical publications

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        161) ERP Finance / IT Analyst – Contract or Full Time Position (San Francisco Bay Area) GN96Q

        DESCRIPTION:

        • Will serve as the technical lead for the ERP Finance module from implementation through ongoing direct support of the Finance group.
        • Should have completed projects utilizing Microsoft Dynamics AX and preferably AX 2012.
        • Will focus on general business processes (AR, AP, GL) as well as 3PL integration, the Sunshine act and data flows from all other resources which will require integration and reporting. These will include but not be limited to CCM / CRM / SFA.
        • This will be accomplished in a compliant manner. 
        • Responsible for custom reporting, system documentation, requirements gathering, end user training, and system testing (unit and integration).

        EXPERIENCE AND QUALIFICATIONS:


        • Demonstrated ability to successfully and simultaneously manage multiple projects with conflicting objectives
        • Excellent verbal and written communication skills
        • Experience with various FP&A tools
        • Ability to facilitate evaluation and compromise among individuals with different perspectives and needs. Must have initiative and the ability to analyze and recommend solutions.
        • Excellent analytical skills, especially at detailed levels, and the ability to organize data into structured plans.
        • A history of professional progress improvement, especially through certification programs or through educational institutions
        • Background in pharma/biotech a plus
        • Prior experience of configuration in association with excellent business logic to guide away from any customization.
        • Demonstrated ability to provide key metrics; make these metrics available and used throughout the corporation. 
        • Working knowledge of Finance and Accounting functions from an operational perspective including tools, processes (Close, Budget cycles, Headcount planning, etc.), & cross-functional interactions.
        • Willingness and flexibility to accommodate needs of finance team through cyclical processes.
        • Collect, analyze, and document business requirements among Finance, Accounting, and Supply Chain functions, and translate these into necessary SOPs to document ERP processes as directed
        • Experience with supporting commercial aspects of Finance ERP implementation (sales, revenue), as well as non-commercial areas of the business.
        • Inventory management including costing of manufacturing by third party manufacturers
        • May assist in an ERP HR module or integration of a stand-alone HR specific application.
        • At least 3-5 years of ERP implementation experience
        • Bachelors degree in IT, Finance or related

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        162) Sr. Product Manager, Software Solutions – Full Time Position (San Francisco Bay Area) B73XS

        DESCRIPTION:

        Position Objective 

        The objective of this position is to develop and manage portfolio of software products and services that provide value added growth for the business segment. This person will develop business cases and own all product management responsibilities for a growing portfolio of software products and services. Will develop and manage a portfolio of on-market and new software products and services. Will be responsible for development of product definition, positioning, pricing and product lifecycle management. Responsibilities include developing market research, leading product management function in new product development teams, managing inventory, pricing, customer communications, support, and revenue forecasts. This position will manage transitioning of products from standalone desktop software to browser based products along with licensing and commercialization models (SaaS) and will manage maintenance and support plans. This position reports to the Director of IT Solutions Product Management.

        • Manage worldwide supply, demand, revenue, margin and pricing for product portfolio; update and present forecasts regularly to management, finance, and manufacturing teams. 
        • Analyze market trends, customer requirements and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation. 
        • Lead new product development process from concept through commercialization, including voice of customer research, definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support and sales. 
        • Lead business aspects of both internally-developed products, as well as those leveraged from external collaborations. .
        • Strong leader within cross-functional teams developing the right product to fill market needs, and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates. 
        • Will partner closely with the Instrument/Product Managers and Technical Marketing Specialists to ensure system synergies and optimal customer experiences. 
        • The software strategy will be developed and executed in concert with the centrally managed CIO office- ensuring best practices from one division are shared across all operating groups.
        • Desired applicants should bring specific experiences in building software development communities, designing software and building scalable architectures as well as SDKs. 
        • Some knowledge of biological sciences and/or genomics is desirable, but not required. An aptitude and interest in learning science including bioinformatics is important. 
        • Candidate must possess a track record of success in driving business innovation, product development, building/leading cross functional teams and effective executive level communication.
        • Implement business strategy for software, including software as a product or a service 
        • Lead product definition teams, defining critical product requirement documents with prioritized features and corresponding business or financial justification with ROI.
        • Assess and evaluate competitive landscape – including product offerings.
        • Monetize software through direct and indirect economic business models, segregating differentiated value propositions for customer segments
        • Accurate market analysis, value proposition and forecasting for new products 
        • Write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups
        • Set pricing to meet revenue and profitability goals
        • Develop customer oriented sales tools and collateral in partnership with market development
        • Manage total product lifecycle, setting organizational cadence for retirement, refresh or enhancement of existing products- in concert with software engineering organization
        • Contribute globally to the company CIO office as part of larger stakeholder community
        • Develop a thorough knowledge of target customer segments, markets and the competition
        • Contribute to overarching IT solutions strategy and roadmap
        • May be required to perform other related duties as required and/or assigned

        EXPERIENCE AND QUALIFICATIONS:

        • Outstanding written and verbal communication skills are required
        • Track record of success in launching software products and services
        • Demonstrated ability to develop business cases, customer and product requirements for strategic and/or complex products, soliciting and integrating Voice of Customer and User Centered Innovation inputs
        • Demonstrated experience successfully managing product lines, pricing, and forecasting
        • Strong leadership skills within cross functional teams; a demonstrated leader through influence with strong negotiation skills
        • Is customer-centric and keenly aware of markets, trends and competitors
        • Is authentic, transparent and leads by example, holding self and others accountable 
        • Organized with strong project management skills
        • Demonstrates a sense of urgency, contagious optimism and a “can do” attitude
        • Inspires, motivates and collaborates with others; team-first attitude
        • Stretches across borders, breaks silos and builds effective partnerships with customers and colleagues
        • Adept with software development life cycle methodologies and software technologies
        • Experience with validated and regulated markets is a plus
        • 25% travel (domestic and international) is required on periodic basis. 
        • This position is not eligible for relocation benefits.
        • Works in an office environment. 
        • 5-8 years’ experience in software Product Management required
        • Bachelor's degree in software development or information management (MBA strong plus)

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        163) Sr. Product Manager, Software – Full Time Position (San Francisco Bay Area) B73XS

        DESCRIPTION:

        The objective of this position is to develop and manage portfolio of software products and services that provide value added growth for the business segment. This person will develop business cases and own all product management responsibilities for a growing portfolio of software products and services. Will develop and manage a portfolio of on-market and new software products and services. Will be responsible for development of product definition, positioning, pricing and product lifecycle management. Responsibilities include developing market research, leading product management function in new product development teams, managing inventory, pricing, customer communications, support, and revenue forecasts. This position will manage transitioning of products from standalone desktop software to browser based products along with licensing and commercialization models (SaaS) and will manage maintenance and support plans. This position reports to the Director of IT Solutions Product Management.

        • Manage worldwide supply, demand, revenue, margin and pricing for product portfolio; update and present forecasts regularly to management, finance, and manufacturing teams.
        • Analyze market trends, customer requirements and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation.
        • Lead new product development process from concept through commercialization, including voice of customer research, definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support and sales.
        • Lead business aspects of both internally-developed products, as well as those leveraged from external collaborations.
        • Strong leader within cross-functional teams developing the right product to fill market needs, and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates.
        • Will partner closely with the Instrument/Product Managers and Technical Marketing Specialists to ensure system synergies and optimal customer experiences.
        • The software strategy will be developed and executed in concert with the centrally managed CIO office- ensuring best practices from one division are shared across all operating groups.
        • Desired applicants should bring specific experiences in building software development communities, designing software and building scalable architectures as well as SDKs.
        • Some knowledge of biological sciences and/or genomics is desirable, but not required. An aptitude and interest in learning science including bioinformatics is important.
        • Candidate must possess a track record of success in driving business innovation, product development, building/leading cross functional teams and effective executive level communication.
        • Implement business strategy for software, including software as a product or a service
        • Lead product definition teams, defining critical product requirement documents with prioritized features and corresponding business or financial justification with ROI.
        • Assess and evaluate competitive landscape – including product offerings.
        • Monetize software through direct and indirect economic business models, segregating differentiated value propositions for customer segments
        • Accurate market analysis, value proposition and forecasting for new products
        • Write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups
        • Set pricing to meet revenue and profitability goals
        • Develop customer oriented sales tools and collateral in partnership with market development
        • Manage total product lifecycle, setting organizational cadence for retirement, refresh or enhancement of existing products- in concert with software engineering organization
        • Contribute globally to the company CIO office as part of larger stakeholder community
        • Develop a thorough knowledge of target customer segments, markets and the competition
        • Contribute to overarching IT solutions strategy and roadmap
        • May be required to perform other related duties as required and/or assigned

        EXPERIENCE AND QUALIFICATIONS:

        • Outstanding written and verbal communication skills are required
        • Track record of success in launching software products and services
        • Demonstrated ability to develop business cases, customer and product requirements for strategic and/or complex products, soliciting and integrating Voice of Customer and User Centered Innovation inputs
        • Demonstrated experience successfully managing product lines, pricing, and forecasting
        • Experienced with software Product Management from concept through commercialization and all phases in between
        • Experience with Cloud/SaaS based software
        • Experienced with software pricing and/or training in pricing such as from Pragmatic Marketing Certification or other similar
        • Strong leadership skills within cross functional teams; a demonstrated leader through influence with strong negotiation skills
        • Is customer-centric and keenly aware of markets, trends and competitors
        • Is authentic, transparent and leads by example, holding self and others accountable
        • Organized with strong project management skills
        • Demonstrates a sense of urgency, contagious optimism and a “can do” attitude
        • Inspires, motivates and collaborates with others; team-first attitude
        • Stretches across borders, breaks silos and builds effective partnerships with customers and colleagues
        • Adept with software development life cycle methodologies and software technologies
        • Experience with validated and regulated markets is a plus
        • 25% travel (domestic and international) is required on periodic basis.
        • This position is not eligible for relocation benefits.
        • Works in an office environment.
        • 5-8 years’ experience in software Product Management required
        • Bachelor's degree in software development or information management (MBA strong plus)

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        164) Bio-Statistician with SAS Programming Skills – Contract (New Jersey) 4624

        DESCRIPTION:

        • Prepare, verify, and manage research data sets from administrative health insurance claims, electronic medical record databases, randomized clinical trials, or other sources as per provided specifications.
        • Perform ad-hoc queries, statistical analysis, modeling, and reporting using SAS.
        • Conduct analytic quality assurance procedures and creation of final deliverables.
        • Develop SAS macro libraries to standardize disease identification, cohort constructions, mapping of healthcare resource utilization and expenditures for product value propositions.
        • Construct drug coding systems to support database activities for key therapeutic R&D and brand activities, and establish and maintain a repository of the coding systems for therapeutic medications, diagnostic or surgical procedures and drug delivery systems.
        • Provide timely analytic support for abstract and manuscript development and submissions to medical/scientific congresses or publications.

        EXPERIENCE AND QUALIFICATIONS:

        • Working knowledge of healthcare industry and drug development
        • Strong expertise in SAS programming including Proc SQL, SAS macros, tables/listings/graphs and SAS/STAT
        • Strong data management skills and demonstrated record of working with large real-world databases
        • Knowledge of R, OpenBUGS, VBA or other analytic packages is a plus
        • Ability to perform statistical, analytic and programming tasks with high efficiency and limited guidance
        • Ability to plan, organize, and work on multiple tasks simultaneously and in multidisciplinary teams.
        • Self-motivated with ability to meet deadlines.
        • Advanced degree in statistics, econometrics, psychometrics, or related quantitative sciences plus >4 years of experiences in claims database analytic work and statistical modeling

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        165) Senior Data Manager – Consultant (San Francisco Bay Area) G108PN

        DESCRIPTION:

        • Position will be 30 to 40 hrs/wk until the end of 2013 and thereafter will be 16 - 20 hrs/wk until the end of 2014.  The company is trying to identify a long term data management consultant.  Finding the best fit is most important and they can accomodate different schedules.
        • Seeking a high level data management consulting with specialized knowledge and detailed attention to carry out data management data review activities in support of one or more clinical research studies. 
        • Working within clinical study teams as an extended team member. 
        • Executing the clinical data management operations against project timelines, and any other priorities.
        • Using defined department metrics as a framework for timely and quality clinical data management deliverables. 
        • Collaborating with peers within and outside the organization to pro-actively manage data availability and integration.
        • Acting as a Lead Data Manager for less complex studies, and as determined by ability and proficiency level in essentials skills.
        • Expected to be skilled in performing all the roles encompassed in the preceding grade levels within the job family as required by the organization.
        • Other activities, special projects and assignments may be given as required.  As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
        • Must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all company policies, and procedures. company policies include compliance with ethics,  environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
        • Lead Data Manager- Responsible for the role which includes executing the design, documentation, testing, and implementation of data collection systems and processes in support of the clinical study teams. Training of study site personnel in CRF completion, and data clarification processes. Coordination of all Data Management Data Review activities and any other Clinical Study Team Data Review (e.g. Masked Data Review). Ensuring completion of all activities leading to the Study Database Lock.
        • Study Data Manager - Responsible for the role which includes the execution of the data review strategy for one or more studies as defined by the individual study Data Management Plan. Initiation and management of the data clarification process, coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock.
        • Study Data Associate - Assist with the role which includes development of clinical data management study documentation (e.g. Data Management Plan, Edit Check Specifications, etc.), and supporting the review in accordance with existing standards. Assist with IVR vendor management and IVR system setup,  conduct, and closeout activities.  Review and/or support maintenance of the IVRS system requirements documentation, language translations, and training materials throughout the system lifecycle.  Leadership of user acceptance testing activities of technologies implemented at a study level.
        • Clinical Study Team Member - Assist with the role which includes representation of the clinical data management & programming organization in one or more clinical study team.
        • Responsible for the role which includes implementation of quality, efficient, and consistent approaches to carrying out clinical data management tasks. Delivering training to clinical data management and other departments, as necessary. Report process gaps and potential misconduct during clinical studies to management.
        • Support Corrective Action and Preventive Action initiatives.

        EXPERIENCE AND QUALIFICATIONS:


        • Experience in Medidata Rave database
        • Intermediate knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials
        • Intermediate knowledge of Research & Development and an understanding of regulatory guidelines/requirements related to R & D (e.g., ICH, GCP, safety reporting)
        • Intermediate knowledge of global standards related to clinical study data management activities (CRF design, data standards, database design, coding and coding dictionaries).
        • Ability to effectively interact with and influence others without direct reporting relationships
        • Ability to multi-task and prioritize
        • Planning, organizational, and project management skills
        • Document writing skills
        • Attention to detail with high quality outputs
        • Negotiation skills
        • Conflict management skills
        • Proactive and critical evaluation of varied and multiple aspects of trial implementation to ensure timely completion and with requisite quality
        • Ability to meet challenging milestones
        • Analytical and problem solving skills
        • Computer skills (word processing, spreadsheets, graphics, PowerPoint)
        • Competencies and skills in the following: cross functional relationships, communication, decision making, execution/results/process improvement, customer satisfaction
        • Ability to travel 5%.
        • Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field: 6 years experience, or BS/BA degree with 4 years experience, or MS degree with 2 years experience.
        • Minimum 2 years experience within a clinical data management organization, preferably within medium-large pharma or CRO.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        166) Clinical Recruiter – Contract or Full Time Position (San Francisco Bay Area) NG104B

        DESCRIPTION:

        • Coordinate with Management Team and Staffing Manager to determine needs 
        • Source and recruit clinical research professionals (Clinical Research Associates, Clinical Project Managers, Clinical Research Assistants and Clinical Line Managers) within the pharmaceutical, biotech, and medical device industry for contract and permanent positions.
        • Identify potential candidates via: internet recruiting, job postings, referrals, pro-active recruiting methods, i.e. cold calling, networking, staff agencies, LinkedIn, maintain database of candidates and professional recruiters
        • Review and respond to incoming and posted resumes
        • Present and sell open jobs to candidates based upon the needs of the position and the candidate's qualifications and preferences
        • Conduct initial phone screens and/or face to face interviews of potential candidates
        • Present qualified candidates to internal managers; coordinate interviews between managers and candidates, and clients, where applicable
        • Conduct/coordinate background screens, skill evaluations, and professional reference checks for all potential new hires
        • Arrange travel for incoming candidates, and submit expense reports for candidate travel
        • Aggressively follow-up with candidates and recruiters (if applicable) throughout the recruitment process from initial interview to final offer and closing
        • Closing responsibilities for all candidates who are extended an offer including securing agreement with the candidate on an entire compensation and benefits package and securing their firm acceptance of the offer.
        • Attend association and industry meetings, job fairs for networking and recruiting
        • Update internal candidate database on regular basis with interview information, client and candidate contacts, new job openings, and placements 
        • Maintain database by calling/e-mailing network minimally every 1-2 months in order to keep contacts active

        EXPERIENCE AND QUALIFICATIONS:


        • Bachelors Degree from an accredited university or college required 2+ years experience as a recruiter in either a permanent or contract capacity
        • Knowledge of and experience in a staffing environment, preferably within a recruitment agency, with an understanding of gross profit margins, markup, and overall profitability to drive recruiting strategy
        • Experience recruiting for clinical research positions and/or knowledge of the clinical industry is required 
        • Ability to self-motivate and develop personal recruiting strategies to meet individual goals
        • Well developed telephone marketing, recruiting and networking skills and the ability to spend 4+ hours per day on the telephone 
        • Exceptional interpersonal, relationship building, presentation and communication skills (verbal & written)
        • Enthusiastic, positive, and persistent approach to business
        • Detail oriented with excellent organizational and time management skills
        • Ability to excel in a fast paced, team environment 
        • Computer proficiency with Outlook, Word & Excel and familiarity with databases

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        167) Diagnostics Product Line Business Owner – Full Time Position (San Francisco Bay Area) RC103X

        DESCRIPTION:

        • Responsible for leading, developing and executing the business, product and go to market (GTM) strategy including business model optimization, new market introduction and ongoing P/L operations for the product line. 
        • Work closely with the extended marketing, product management, sales, software development and executive teams to develop business plans based on in-depth market analysis, define the overall product strategy, and define and implement the product GTM strategy and programs.  
        • Be the key go-to business / product line leader who owns end-to-end business success for the product in the market including P/L.
        • Own the GTM strategy, planning and execution engaging with cross-functional teams to align and manage key capabilities and timelines for successful delivery.
        • Be the go-to person for understanding and guiding product strategy and together with NGS development team drive product roadmap and execution.
        • Conduct market research and develop frameworks for identifying, evaluating and prioritizing business opportunities.
        • Work with business development / channel development to recruit and support new and existing channel partners expanding market reach and penetration.
        • Work with marketing to define, execute and deliver successful marketing programs to generate demand and achieve revenue targets.
        • Be the business and product champion/evangelist externally at events, customer and channel engagements, and the passionate voice of the customer internally.

        EXPERIENCE AND QUALIFICATIONS:

        • Entrepreneur with exceptional value creation instincts and problem solving skills.
        • Deep understanding of the biological diagnostics marketplace with experience successfully launching new molecular diagnostics products.
        • A passionate self-starter with a combination of business, product, and technical knowledge who has a proven ability to kick-start new products and see them through to successful completion
        • Able to evaluate, frame and make compelling recommendations so the executive team can effectively make business strategy and product investment decisions.
        • A strong leader and evangelist who is results driven, detailed, follows through, and has an ability to work effectively at all levels within the organization, customers and partners.
        • Strong analytical skills with experience in data driven decision-making.
        • Comfortable working with scientific, technical, medical and non-technical personnel with exceptional communication skills, including the ability to effectively present to customers.
        • MD or BS in life sciences with MBA or equivalent experience (including relevant advanced studies preferred, ie MS, PhD, bioinformatics certification, etc).
        • Solid business experience with a minimum five years experience in marketing, business, business development and/or channel development.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        168) Regional Clinical Research Associate – Full Time Position (Texas) N104BX

        DESCRIPTION:

        • Primary responsibility of this position is to provide site management and monitoring of clinical research studies. 
        • Verification of reported study data
        • Investigational product accountability
        • Oversight of compliance and training of site staff on regulatory and protocol-related issues
        • Review of regulatory documents
        • Accurate and timely documentation
        • Reporting and communication
        • Oversight of safety reporting   

        EXPERIENCE AND QUALIFICATIONS:


        • Infectious disease, oncology, dermatology and/or ophthalmology experience a plus.
        • Understanding of regulatory principles and practices
        • Attention to detail
        • Ability to efficiently perform multiple tasks
        • Ability to identify and solve logistical problems
        • Excellent organizational skills
        • Ability to maintain an effective travel schedule
        • Flexibility with changing priorities
        • Effective communication and personal skills necessary for successful teamwork.
        • Travel up to 65% may be required.
        • General computer skills with proficiency in PC-based Microsoft Word and Excel are mandatory. 
        • Qualified candidates must have an RN or 4-year college degree, preferably in a biomedical or science related field, and at least 3 years recent experience as a Clinical Research monitor.  

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        169) Senior Software/Scientific Quality Engineer – Full Time Position (San Francisco Bay Area) MZ103R

        DESCRIPTION:

        • Work with a dynamic and hard-working team to help improve the quality of the flagship systems biology product as well as other scientific analysis products and services.  
        • Work towards improving overall product quality, testing and risk management process.  
        • Work closely with developers, product management, customer service and other groups to proactively seek product information, develop test plans, derive practical use cases, author test cases.
        • Responsible for communicating risks, test status, results to QA, Development, Management.  
        • Perform functional black box testing, white box and test automation. 
        • Scientific testing of biological content through our flagship software
        • Develop test automation scripts with Java based automation tools (such as FitNesse, Selenium, etc)
        • Functional testing including using both GUI and backend tests
        • Involvement with Agile iterative software development process - test-driven development, continuous integration testing, rapid automation to efficiently build best industry software
        • Interpret requirements, specifications to develop test plans, test cases, test documentation
        • As an individual contributor, hands-on involvement in all areas of Quality Assurance including: processes, test plan, test case creation, bug tracking lifecycle, functional testing
        • Think from a customer perspective , creatively solve real user problems
        • Make recommendations for QA process, best practices, other implementation as per business goals
        • Recommend, implement enhancements to automated testing framework 
        • Coordinate/lead efforts for cross functional testing and/or integration tasks

        EXPERIENCE AND QUALIFICATIONS:

        • Strong knowledge of molecular biology and genomics
        • Proficiency with Java or other object-oriented programming languages, automation with WebDriver (Selenium 2), Unix and Windows operating systems, and experience with testing web-based and java-based applications
        • Experience in both white and black box testing and with performance/load testing web apps
        • Familiarity with SQL and database design, and version control software such as CVS or Subversion, and defect-tracking software /processes
        • Experience developing test plans, designing, implementing, executing, analyzing test cases, writing bug reports, assessing risk 
        • Scripting experience with Perl or Python 
        • Experience in test automation using Silk Test, Fitnesse
        • Strong experience with analysis of algorithms, statistical analysis skills and understanding Agile Development Methodologies
        • Experience with multi-tiered web technologies including web servers and application servers
        • Experience with or interest in working with life sciences:
        • Familiarity with the bioinformatics field and with computational biology tools and practices
        • Familiarity with viral and bacterial pathogens, host-pathogen interaction, disease response, infection and inflammation pathways
        • Experience working with data from Next Generation Sequencing (NGS) platforms
        • Familiarity with ontologies, specifically bio-ontologies.
        • Familiarity with general bioinformatics databases and computational biology resources
        • Minimum 3+ years experience in biotech or bioinformatics
        • Preferred 2+ years experience in molecular biology research
        • Preferred 3+ years experience in test automation
        • Minimum M.S. in Molecular Biology (biology, biochemistry, genetics) or equivalent industry experience.
        • Preferred B.S. /M.S. in Computer Science or equivalent industry experience.
        • Preferred PhD in Molecular Biology

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        170) Senior Software/Scientific Quality Engineer – Full Time Position (San Francisco Bay Area) MZ103R

        DESCRIPTION:


        • Work with a dynamic and hard-working team to help improve the quality of the flagship systems biology product as well as other scientific analysis products and services.  
        • Work towards improving overall product quality, testing and risk management process.  
        • Work closely with developers, product management, customer service and other groups to proactively seek product information, develop test plans, derive practical use cases, author test cases.
        • Responsible for communicating risks, test status, results to QA, Development, Management.  
        • Perform functional black box testing, white box and test automation. 
        • Scientific testing of biological content through our flagship software
        • Develop test automation scripts with Java based automation tools (such as FitNesse, Selenium, etc)
        • Functional testing including using both GUI and backend tests
        • Involvement with Agile iterative software development process - test-driven development, continuous integration testing, rapid automation to efficiently build best industry software
        • Interpret requirements, specifications to develop test plans, test cases, test documentation
        • As an individual contributor, hands-on involvement in all areas of Quality Assurance including: processes, test plan, test case creation, bug tracking lifecycle, functional testing
        • Think from a customer perspective , creatively solve real user problems
        • Make recommendations for QA process, best practices, other implementation as per business goals
        • Recommend, implement enhancements to automated testing framework 
        • Coordinate/lead efforts for cross functional testing and/or integration tasks

        EXPERIENCE AND QUALIFICATIONS:


        • Strong knowledge of molecular biology and genomics
        • Proficiency with Java or other object-oriented programming languages, automation with WebDriver (Selenium 2), Unix and Windows operating systems, and experience with testing web-based and java-based applications
        • Experience in both white and black box testing and with performance/load testing web apps
        • Familiarity with SQL and database design, and version control software such as CVS or Subversion, and defect-tracking software /processes
        • Experience developing test plans, designing, implementing, executing, analyzing test cases, writing bug reports, assessing risk 
        • Scripting experience with Perl or Python 
        • Experience in test automation using Silk Test, Fitnesse
        • Strong experience with analysis of algorithms, statistical analysis skills and understanding Agile Development Methodologies
        • Experience with multi-tiered web technologies including web servers and application servers
        • Experience with or interest in working with life sciences:
        • Familiarity with the bioinformatics field and with computational biology tools and practices
        • Familiarity with viral and bacterial pathogens, host-pathogen interaction, disease response, infection and inflammation pathways
        • Experience working with data from Next Generation Sequencing (NGS) platforms
        • Familiarity with ontologies, specifically bio-ontologies.
        • Familiarity with general bioinformatics databases and computational biology resources
        • Minimum 3+ years experience in biotech or bioinformatics
        • Preferred 2+ years experience in molecular biology research
        • Preferred 3+ years experience in test automation
        • Minimum M.S. in Molecular Biology (biology, biochemistry, genetics) or equivalent industry experience.
        • Preferred B.S. /M.S. in Computer Science or equivalent industry experience.
        • Preferred PhD in Molecular Biology

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        171) Manager, Medical Information – Full Time Position (San Francisco Bay Area) GT96B

        DESCRIPTION:

        Medical Information, within the Medical Affairs department, works closely with various functional areas within the organization to communicate accurate, consistent and timely information regarding products and therapeutic areas, including:  contributing to clinical development initiatives, strategy building for brands, and creation of Medical Affairs infrastructure.  This position will report directly to the Director Medical Affairs.

        Key Accountabilities/Core Job Responsibilities:
        • Develop department infrastructure for receiving, documenting and responding to product inquiries ensuring compliance with Office of the Inspector General Guidelines.
        • Create and maintain a comprehensive written response document and FAQ database for company products.
        • Respond to daily medical information requests from the professional community, patients, and internal colleagues with timely, balanced, scientific and relevant disease area and product information.
        • Diligently evaluate inquiries for adverse events taking appropriate action in compliance with company policy.
        • Assess and analyze company and competitor product literature.  
        • Communicate effectively with other functional groups to cultivate a positive relationship.
        • Develop product expertise and in-depth knowledge in target disease areas.
        • Maintain and utilize systems to manage medical and product relative information.
        • Participate in internal project teams and training programs.
        • Provide scientific support at various congresses.

        EXPERIENCE AND QUALIFICATIONS:

        • Training and/or knowledge of Good Clinical Practice (GCP) and global regulations.
        • Experience with clinical research, publication activities, congress/conference/academy presentations.
        • Experience in literature searches, literature evaluation, and drug information concepts.
        • Ability to summarize complex information and present in a clear, concise, and scientifically accurate manner to a range of audiences.
        • Knowledge of ICH guidelines, FDA Drug Regulations with respect to DDMAC, PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, and OIG Compliance Program Guidance for Pharmaceutical Manufacturers.
        • Think strategically; apply knowledge and analytical skills in a highly regulated environment; and align medical and commercial strategies.
        • Effectively build relationships and work with global medical thought leaders.
        • Excellent interpersonal, written and verbal communication skills.
        • Strong problem solving, decision-making, influencing, negotiation, organization and time management skills.
        • Willing to travel 20% of time.
        • 5+ years of experience in industry (e.g., biotech/pharmaceutical/medical device company, Contract Research Organization), academic research, or public health working in Medical Information.
        • PharmD or other graduate degree preferred.  In general not seeking a US licensed MD as this is a very hands on position.
        • Oncology experience preferred.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        172) Clinical Database Programmer – Full Time Position (New York / New Jersey) M100PT

        DESCRIPTION:

        • Accountable for the timely production of clinical database structures, clinical data logic checks, clinical data extraction programs and tools and the conversion of clinical views to extraction datasets for multiple uses.
        • Corresponding Process Diagrams for Electronic Data Capture (EDC) studies)
        • Database programming, including the creation and implementation of eCRF behaviors, validation and derivation procedures and complex data logic checks/programs electronic case report forms (eCRF) (process diagrams for eCRF Design and Set-up and eCRF Updates)
        • Evaluates and manages changes to eCRF / database programming as a result of study change requests or UAT findings.
        • Presents eCRF update options to the SMT.
        • Sets up and manage data extraction (process diagrams for Data Extraction, Final Extraction and Unblinding, Set-up for Data Extraction and EDC file transfer protocol (FTP) Accounts for Data Extracts)
        • Develops, tests and reviews extraction programs, based on user requirements, for reporting and statistical analysis
        • Develops and maintains custom outputs for multiple uses (e.g. medical data review, clinical study reports)
        • Trouble-shoots and contributes to the resolution of data loading and extraction issues
        • Implements software programming standards (e.g. study data tabulation model (SDTM).
        • Communicates effectively with members of the study management team (SMT) to ensure that assigned study-level reporting requirements are clearly communicated and agreed upon
        • Liaises with colleagues for consistent approach to modeling and extraction
        • May participate in SMT and other meetings as needed
        • May be required to give presentations on functional topics

        EXPERIENCE AND QUALIFICATIONS:

        • College/University degree in science or computer-related subject with significant bioinformatics content or two or more years experience in handling biomedical data using programming languages such as PL/SQL, C# or SAS.
        • 5+ to 7 years of experience. 
        • Bachelor's Degree.
        • Willingness to travel occasionally.
        • Demonstrated knowledge of programming Clinical Data Management applications with experience of relational databases most specifically with RAVE.
        • Good written and verbal English communication skills demonstrated by an ability to present clear instruction/direction to individuals and teams.
        • Experience of working as part of or leading a team with a proven ability to make an active contribution to the team's performance. 
        • Ability to communicate clearly with technical and non-technical colleagues.
        • Good presentation skills

         

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        173) Associate Scientist I - R&D – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) 73X9093

        DESCRIPTION:

        • Conduct pre-designed scientific or engineering experiments using laboratory equipment and calculations. 
        • Verify and validate product design and performance during the development cycle, from feasibility through product release.  
        • Products include benchtop instruments, sample preparation, synthetic biology, protein expression, protein analysis, and enzymes. 
        • Plan the use of equipment, materials and own time. 
        • Assist in lab procurement, calibration or maintenance of equipment. 
        • Make detailed observations and basic data analysis. 
        • Advise supervisor of factors that may affect quality, accuracy, timeliness and usefulness of data. 
        • Suggest options /ideas for additional experiments. 
        • Troubleshoot experiments with assistance from supervisor. 
        • Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment. 
        • With supervisor’s guidance, become familiar with literature directly associated with assigned project and transmit information gathered to other members of the scientific team.  
        • Maintain complete and thorough lab notebook and training file in accordance with division standard. 
        • Comply with all company safety regulations and procedures. 
        • Position exercises judgment within defined procedures and practices to determine appropriate action. 
        • Normally receives general instruction on routine work, detailed instruction on new assignments. 
        • Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity. 
        • Works on problems where analysis of situation or data requires a review of identifiable factors. 
        • Accuracy is required in performing all functions of this position, mistakes in work could cause substantial interpretive errors.  
        • May be required to perform other related duties as required and/or assigned.
        • Running tests and experiments in the laboratory. 
        • Preparing PCR reaction plates and running on AB qPCR systems.
        • Contributing to writing and executing test plans and reports.
        • Executing statistical data analysis.
        • Major responsibilities are understanding and executing procedures, accurately recording data, and assisting in data analysis. 

        EXPERIENCE AND QUALIFICATIONS:

        • Experience working in a lab environment and familiarity with basic laboratory practices a must.
        • Good communication skills and experience developing testing, measurement and characterization methods are desired.
        • Familiarity with proper documentation practices and technical writing experience, including creating test protocols and SOPs is desired
        • Experience with JMP data analysis
        • Qualified candidates must have a degree in the field of Bioengineering, Mechanical Engineering, Chemical Engineering, Chemistry, Molecular Biology, or a related field and some laboratory experience. 
        • An interdisciplinary education and/or experience is preferred to allow for a systems-level approach on projects.  
        • Experience in statistical data analysis, using tools such as JMP, Minitab, Excel macros, and/or MatLab is also desired. 

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        174) Accountant II – Contract (New Jersey) 4972

        DESCRIPTION:

        • Assists in the monthly closing process by completing items required to effectively close the books (booking journal entries, etc). 
        • Must work closely with the SSC on the guidelines and any changes to the processes.  
        • Assist in the complete process of preparing, reviewing, coordinating, and reporting actual financial results accurately and timely. 
        • Assists in the preparation of non-recurring reports and/or schedules for "ad hoc" requests as they arise.
        • Responsible for the various day-to-day accounting tasks across the accounting functional areas such as reconciling accounts, preparing reports, analyzing financial data, etc.  The functional areas include: Reporting, Fixed Assets, Inventory, Cash and Benefits Accounting
        • Accountable for delivering service and meeting objectives defined in the SSC Service Level Agreements for all businesses.  
        • Partners with the business units to continuously improve the services, accuracy and timing of the reporting function. 
        • Maintains and cultivates strategic partnerships with controlling and management teams to ensure integration and implementation of efficient process and policies 
        • Supports external and internal audit requests and ensures team’s compliance with all Sarbanes-Oxley internal control requirements for assigned areas.

        EXPERIENCE AND QUALIFICATIONS:


        • Strong Excel skills (pivot tables, access databases, etc.).
        • Ability to prioritize and manage multiple projects simultaneously. 
        • Must be a self-starter - have a high degree of personal initiative. 
        • Strong interpersonal and communication skills. 
        • Bachelor’s degree from an accredited four-year college or university

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        175) Project Manager (up to Director Level) – Full Time Position (San Francisco Bay Area) G96FD

        DESCRIPTION:

        • Seeking a senior level Project Manager who will manage regulatory timelines in clinical development. 
        • Work in Project Management department, partnering with Regulatory Leader to manage the development and execution of regulatory timelines aligned with corporate goals.
        • Establish and maintain functionally integrated project schedules to enable accurate project and ensure accurate inputs are provided into business planning processes
        • Ensures alignment with project sub-teams and functional partners.
        • Ensure regulatory project team activities and decisions are clearly communicated, documented and archived, act as a primary contact for regulatory project team related information.
        • Identifies, recommends, and manages the implementation of process and other improvements; whether pertinent to departmental and/or corporate.

        EXPERIENCE AND QUALIFICATIONS:

        • Advanced degree in science is desired (e.g. MS, PhD, MBA) or commensurate experience.
        • 6 or more years multi-disciplinary experience in the biotech/pharmaceutical industry, with involvement in drug development for at least 2 years.
        • Some regulatory experience preferred, must be comfortable with managing regulatory timelines.
        • Excellent organization skills, multitasking, and clear communication is needed.
        • Proficiency with project management practices, tools, and methodology including MS Project.
        • Knowledge of overall drug development process relevant to pharmaceutical/biotech organizations.
        • Financial acumen; capable of planning and oversight of project budgets and product valuations and an understanding of portfolio management concepts.
        • Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
        • Strong analytical skills, with an ability to communicate complex issues in a simple way.
        • Demonstrate ability to translate strategy into action.
        • Strong influence, negotiation, and presentation skills.
        • Proven track record of good decision making and exercising sound judgment.
        • Results and detail-oriented; self-motivated.
        • Proven experience using Project Management software to manage complex project timelines and resources.
        • Working knowledge/understanding of best-practice alliance/collaboration management principles and concepts, techniques and tools.
        • Successful experience in managing direct reports a plus.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        176) Project Manager (up to Associate Director Level) – Full Time Position (San Francisco Bay Area) G96FD

        DESCRIPTION:

        • Seeking a senior level Project Manager who will manage regulatory timelines in clinical development. 
        • Work in Project Management department, partnering with Regulatory Leader to manage the development and execution of regulatory timelines aligned with corporate goals.
        • Establish and maintain functionally integrated project schedules to enable accurate project and ensure accurate inputs are provided into business planning processes
        • Ensures alignment with project sub-teams and functional partners.
        • Ensure regulatory project team activities and decisions are clearly communicated, documented and archived, act as a primary contact for regulatory project team related information.
        • Identifies, recommends, and manages the implementation of process and other improvements; whether pertinent to departmental and/or corporate.



        EXPERIENCE AND QUALIFICATIONS:

        • Advanced degree in science is desired (e.g. MS, PhD, MBA) or commensurate experience.
        • 6 or more years multi-disciplinary experience in the biotech/pharmaceutical industry, with involvement in drug development for at least 2 years.
        • Some regulatory experience preferred, must be comfortable with managing regulatory timelines.
        • Excellent organization skills, multitasking, and clear communication is needed.
        • Proficiency with project management practices, tools, and methodology including MS Project.
        • Knowledge of overall drug development process relevant to pharmaceutical/biotech organizations.
        • Financial acumen; capable of planning and oversight of project budgets and product valuations and an understanding of portfolio management concepts.
        • Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
        • Strong analytical skills, with an ability to communicate complex issues in a simple way.
        • Demonstrate ability to translate strategy into action.
        • Strong influence, negotiation, and presentation skills.
        • Proven track record of good decision making and exercising sound judgment.
        • Results and detail-oriented; self-motivated.
        • Proven experience using Project Management software to manage complex project timelines and resources.
        • Working knowledge/understanding of best-practice alliance/collaboration management principles and concepts, techniques and tools.
        • Successful experience in managing direct reports a plus.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        177) Manager/ Assoc Director CMC Regulatory – Full Time Position (San Francisco Bay Area) NB96X

        DESCRIPTION:

        • Reports to the Director CMC Regulatory
        • Assists with CMC regulatory by providing regulatory strategy and support to global development teams and facilitating all regulatory filings relating to CMC.
        • Assists with CMC regulatory strategy.
        • Represents RA CMC at project team meetings and coordinates regulatory  workflow between departments as well as CROs.
        • Coordinates, writes, compiles CMC  document packages and investigational drug shipment related activities for  drug manufacturing according to regulations/guidelines and company SOPs. 
        • Assists with regulatory leadership for module 3 of upcoming eCTD filings.
        • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
        • Assists CMC Regulatory Director with interactions with regulatory authorities on CMC issues. 
        • Participates in Regulatory Affairs initiatives to improve company standards and systems.

        EXPERIENCE AND QUALIFICATIONS:

        • Ability to manage multiple and varied tasks in a fast-moving environment.
        • Good record-keeping skills. 
        • Proficient with computer (MS Office) and internet skills. 
        • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
        • Proven ability to communicate with executive management,  cross-functional team members and operational staff.
        • Flexible attitude with respect to work assignments, and new learning.
        • 3+ years relevant regulatory CMC experience.
        • BS and advanced degree in life sciences (MS, PhD or PharmD or equivalent).

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        178) Project Manager – Full Time Position (San Francisco Bay Area) RH73B

        DESCRIPTION:

        The Project Manager for the Medical Sciences Business manages the development of internally or externally developed diagnostics products. This responsibility requires involving departmental or cross-functional teams focused on the delivery of new products. Plans and directs schedules and monitor budget/spending. Monitors the project from initiation through delivery. Organizes the interdepartmental activities ensuring completion of the project/product on schedule and within budget constraints. Has overall project management responsibility. In this role, direct people management responsibility is not required
        • Define and implement PCP process for various IVD development projects for the business unit.  
        • Lead cross functional core team through product launch; developing project plan and timeline; coordinating with internal or external partner teams to achieve project / product deliverables 
        • Be the internal expert in PCP process and IVD project management. 
        • Facilitative leadership skills, particularly the ability to influence stakeholders in other functions over whom the Project Manager has no direct authority. 
        • Must be a highly-motivated driver able to complete tasks by leveraging relationships and established goals. 
        • Analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations. 
        • Willingness to be flexible and adaptable in a complex, matrixed environment. The ability to adapt to changing needs and parameters caused by time, budget, or other constraints 
        • Discusses and presents factual information to other members of the team. 
        • Ability to convey very complex information in both written and oral form. 
        • Actively and constructively contributes to core team’s efforts through networking within the organization and effectively communicating to Med Sci management. 
        • Able to influence others and gain acceptance and build consensus.
        • Ability to manage moderately complex projects and initiatives.
        • Acts as a mentor/role model for team members. 
        • Demonstrates understanding of company’s external customer needs and how they affect business unit products and services. 
        • Makes decisions that involve the consideration of complex issues.
        • Works autonomously and checks-in as decisions are made.
        • Erroneous decisions or recommendations may result in failure to achieve critical organizational objectives. May cause substantial expenditure of time, people and funds and may jeopardize unit activity. 

        EXPERIENCE AND QUALIFICATIONS:

        • The candidate will have 3-5 years of project management experience in IVD or medical device product development.  
        • Working knowledge of design control and FDA QSR requirements.
        • Microsoft Project Management skills
        • Have proven ability to execute through influence within a matrixed organization.
        • Have an undergraduate degree in science or engineering. Additional advanced degrees are preferred but not required.  
        • The candidate will be self-motivated & a driving force of execution in their current or past organizations.   
        • Familiarity with requirements tracking tools
        • Negotiations skills
        • Leading through influence
        • Strong written and verbal communication skills

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        179) (Senior) Clinical Trial Manager – Full Time (San Francisco Bay Area) R96TW

        DESCRIPTION:

        Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines.  Leads study management team, including oversight of CRO and Vendors.  Coordinates the training of staff involved in clinical trial management.  Provides training to clinical operations staff and performs performance appraisals of direct reports.
         

        Key Accountabilities/Core Job Responsibilities:
        • Responsible for  the preparation and finalization of project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
        • Responsible for  the selection of investigators and study sites
        • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor
        • Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT
        • Ensure that CRF data queries are resolved
        • Coordinate and manage Investigational Product including overall accountability and reconciliation
        • Responsible for  the preparation of study  budgets and timelines
        • Manage project timelines and vendor performance to meet departmental and corporate goals
        • Manage study budget and payment process for all clinical trial vendors including investigative sites
        • Monitor and track clinical trial progress and provide status update reports
        • Manage all clinical trial vendors
        • Responsible for selection of CRO study staff and coordinating training including documentation
        • Hire, train and oversee study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
        • Lead with minimal supervision in the planning of investigator meetings and making presentations, as required
        • Lead  the review of clinical data at the CRF, data listing, and report table levels
        • Represent Clinical Operations at the Project Team level for individual studies, as appropriate 
        • Partner with other research and development groups to achieve deliverables
        • Participate in Site Initiation Visits (SIVs) as required
        • Co-Monitoring of regional sites for adherence to protocol and GCP as required
        • Travel as required to carry out responsibilities
        • Identify and escalate site, vendor and study related issues to supervisor, as appropriate
        • Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
        • Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
        • Perform other duties as assigned

        EXPERIENCE AND QUALIFICATIONS:

        • Must have demonstrated expertise in relevant clinical operations activities
        • Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
        • Good organization and planning skills
        • Strong interpersonal skills and communication skills (both written and oral)
        • Ability to problem solve and delegate appropriate tasks to subordinates
        • Knowledge of ICH/GCP guidelines and FDA regulations
        • Strong leadership skills, self-motivated, adaptable to a dynamic environment
        • Able to collaborate effectively with the study team, cross-functional team members, and external partners
        • Proficiency in MS Word, Excel and PowerPoint
        • Able and willing to travel approximately 25-30%  
        • 7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience)
        • Experience in oncology preferred
        • Experience in global trials preferred

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        180) Human Resources Assistant – Full Time (San Francisco Bay area)

        DESCRIPTION:

        • Set up and confirm candidate interviews with clients
        • Post job advertisements
        • Update company applicant tracking system
        • Find and submit qualified candidates for open positions in the client facilities. 
        • Must have exceptional interpersonal skills to manage the recruitment database, post jobs, generate leads, pre-screen and follow-up with candidates.
        • Other tasks as needed

        EXPERIENCE AND QUALIFICATIONS:

        • Excellent computer skills: Applicant tracking systems; database experience, Microsoft Word, Excel, Outlook
        • Bachelor’s degree strongly preferred -- BS/BA in Biology or Life Science preferred.
        • Must be self-motivated, present well and be able to develop relationships with candidates and individuals at all levels of the of the organization.
        • Ability to navigate through change and demonstrate flexibility as organizational needs shift.
        • Excellent organizational skills and the ability to work independently are extremely important.
        • Must live in the United States or Puerto Rico and have U.S. work status.  San Francisco Bay area preferred.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        181) Internal Auditor III (Finance) – Full Time Position (San Francisco Bay Area) H95TJ

        DESCRIPTION:

        • Conducts internal financial audits and risk assessments. 
        • Performs and documents financial records for integrity and transaction accuracy. 
        • Identifies control and process deficiencies and reports discrepancies. 
        • Prepares audit plans and understands the specific issues to be evaluated. 
        • Executes internal audits of established business process controls. 
        • Develops formal written reports to communicate audit results to management and makes recommendations as appropriate. 
        • May facilitate work of external auditors during on-site visits. 
        • Requires audit knowledge and skills in finance/accounting and/or information system operations.
        • Up to 25% international travel may be required.

        EXPERIENCE AND QUALIFICATIONS:


        • 3-5 years current experience in a Big 4 Accounting Firm or second tier firm.
        • Forensic accounting experience is a plus.
        • Finance investigation experience is a plus.
        • CFE, CPA or CIA certifications a plus.
        • Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with SAP ERP software desired. 
        • Domestic and possibly international travel will be occasional.
        • Bachelors degree and 5 years of related experience or Masters Degree with 3 years of related experience.


        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        182) CRAII / Senior Clinical Research Associate II (SCRA) – Contract or Full Time Position (San Francisco Bay Area) B80CR

        DESCRIPTION:

        • Reports to Clinical Program Manager (CPM).
        • May review and edit documents including protocols, informed consents, case report forms, monitoring plans, edit specifications, abstracts, presentations, manuscripts and clinical study reports
        • May write protocols and protocol amendments, with supervision
        • Will present at investigator meetings
        • May manage CROs and/or contract CRAs with guidance from CPM
        • Chair or participate in meetings or conference calls with CROs and multi-disciplinary study team
        • Assist in review of data and preparation of safety, interim and final study reports, and resolution of data discrepancies
        • Assist in setting and updating study timelines
        • Participate in abstract preparation, presentation preparation and manuscript development
        • Train clinical site staff to ensure protocol and regulatory compliance. May assist in training CRA I and CRA Assistant

        EXPERIENCE AND QUALIFICATIONS:

        • Bachelor’s degree in a relevant scientific discipline or equivalent
        • At least 3 years Clinical Operations Pharmaceutical experience for CRAII; and at least 5.5 year of relevant experience as a CRA in the biotech / pharmaceutical (not diagnostics / device) industry in an in-house (not Regional monitor, CRO or Hospital / Site based position) for SCRA.
        • Phase 3 experience, Study start-up experience, and Global trial experience are desirable
        • Must have some experience with direct monitoring of sites (in order to manage the CRO; direct monitoring is not part of this job)
        • Experience in a start-up environment preferred
        • Knowledge of GCP and ICH guidelines
        • Ability to work collegially within a team
        • Able to perform routine assignments with general instructions and new assignments with detailed instructions
        • Must be able to go on occasional travel (this is an in-house position so very little travel is expected)
        • Proficiency with MS Word, Excel, Outlook, and PowerPoint
        • Basic Relocation Provided

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        183) Clinical Program Manager – Full Time Position (San Francisco Bay Area) R80BS

        DESCRIPTION:

        Clinical Program Manager to manage multiple clinical trials.

        • Reports to Director level
        • Manage late stage global clinical study teams, CRO’s and Vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
        • Manage CRA to SCRA level clinical operations personnel

        EXPERIENCE AND QUALIFICATIONS:

        • Bachelor’s degree in a relevant scientific discipline or equivalent
        • At least 7 years of relevant clinical experience in the pharmaceutical industry or equivalent with 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment, and 1 year prior experience as a CPM preferred
        • 1+ years managing staff/direct reports preferred
        • Must be hands on and used to a start-up environment
        • Knowledge of GCP and ICH guidelines required
        • Proficiency in the implementation, monitoring, and management of clinical trials
        • Able to work collegially within a team and carry out duties/responsibilities with general instructions
        • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
        • Must be willing to travel occasionally (this is an in-house position so very little travel is required)
        • Previous experience as a CPM managing more than one trial in Phase 3 or a large Phase 2B trial
        • Study start-up experience is highly desirable
        • Global (Asia, Europe, South America, Middle East, or Africa) trial experience is highly desirable
        • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
        • Basic relocation provided

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        184) Technical Recruiter / Sourcing Specialist – (Full Time or Part-time, Contract or FTE; United States)

        DESCRIPTION:

        We have openings for several recruiters and are therefore flexible in terms of the work arrangement.

        • Primary responsibilities are to source open positions with qualified candidates
        • Document/track recruiting activities in candidate tracking system.
        • Source, screen and interview candidates

        EXPERIENCE AND QUALIFICATIONS:

        • Must have minimum of 4 years of solid recruiting experience.
        • Experience must be with Pharma, diagnostics or medical devices companies.
        • Prior experience and absolute comfort with making cold calls
        • Must be self-motivated, present well and be able to develop relationships with candidates.
        • Ability to navigate through change and demonstrate flexibility as organizational needs shift.
        • Excellent organizational skills and the ability to work independently is very important
        • Must develop and implement creative sourcing strategies to identify talent in addition to utilizing company sourcing tools
        • Bachelor degree required
        • Must live in the United States or Puerto Rico and have U.S. work status

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        185) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

        DESCRIPTION:

        Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules and the ability to work independently in a team environment.

        Principal responsibilities include:

        • Perform laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
        • Perform, review and document laboratory quality control procedures.
        • Operate, maintain and troubleshoot laboratory equipment.
        • Prepare reagents required for laboratory testing.
        • Review, interpret and report patient results.
        • Independently identify and troubleshoot basic problems that adversely affect test performance.
        • Report all concerns of test quality and/or safety to the Supervisor or Safety Officer
        • Assist with final development of protocol and processes for a Laboratory Developed Test and perform other duties as assigned.

        EXPERIENCE AND QUALIFICATIONS:

        • Proven successful track record and comfortable with a start-up environment.
        • Must possess a valid California CLS license, generalist preferred.
        • Completion of a CLS training program at an accredited institution or clinical laboratory work experience within the last five years.
        • Possess working knowledge of local, state and federal laboratory regulations.
        • Computer skills a must, automation skills preferred.
        • Ability to analyze and problem solve basic issues that impact test performance.
        • Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
        • Must communicate effectively with coworkers and non-laboratory personnel
        • Able to integrate and apply feedback in a professional manner.
        • Able to manage daily test processing needs with high emphasis on quality.
        • Ability to work as part of a team.
        • Ability to perform repetitive tasks.
        • High volume laboratory experience preferred.
        • Training in molecular biology techniques preferred.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        186) Licensed PM Shift Clinical Laboratory Scientist (CLS) Supervisor – Full Time Position (San Francisco Bay Area) J75SP

        DESCRIPTION:

        The PM Clinical Laboratory Scientist Supervisor is responsible for supervising Clinical Laboratory Scientists and Clinical Lab Assistants, performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures, and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask, flexibility with tasks and schedules, and the ability to work independently in a team environment.

        Principal responsibilities include:

        • Performance of laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
        • Performance, review and documentation of laboratory quality control procedures.
        • Operation and maintenance of laboratory equipment.
        • Preparation of reagents required for laboratory testing.
        • Review, interpretation and reporting of patient results.
        • Identifying and remedying problems that adversely affect test performance.
        • Reporting all test quality and safety concerns to the Laboratory Director or Safety Officer.
        • Preparing performing reviews on testing personnel within specified time-frames.
        • Tracking training and competency of testing personnel.

        EXPERIENCE AND QUALIFICATIONS:

        • A successful track record and comfortable with a start-up environment.
        • Must possess a valid California CLS license.
        • A minimum of six years of relevant laboratory experience.
        • Possess working knowledge of local, state and federal laboratory regulations.
        • Strong computer skills, and automation experience preferred.
        • Ability to analyze and problem solve basic issues that impact test performance.
        • Strong communication skills with the ability to maintain open communication with coworkers, non-laboratory personnel, and managers.
        • Previous supervisory skills a plus.
        • Work the PM shift (3:30-12:00 or 4:30PM to 1:00AM, still TBD).

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        187) CMC Regulatory Director/ Sr. Director – Full time Position (San Francisco Bay Area) L62EJ

        DESCRIPTION:

        Responsible for developing global regulatory strategy, writing high quality dossier and leading teams for assigned projects to obtain timely approvals of applications. The Technical Regulatory leadership team is composed of seasoned technical experts whose focus is to collaborate with scientists and International Health Authorities to drive development of innovative regulatory policy, and ensure the approval of products developed using novel and efficient process development strategies.

        • Position will require regular interaction with management from multiple internal functional areas, corporate partners, international regulators and external experts.
        • Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.
        • Support both US ex-US filings, as appropriate and as requested by corporate partners.
        • Additional responsibilities will include leading departmental operational excellence and business process initiatives, as well as, proactively communicate with Regulatory and cross functional personnel and partners in support of internal and partner associated goals.

        EXPERIENCE AND QUALIFICATIONS:

        • Must maintain a high level of professionalism, efficiency, and commitment.
        • Demonstrate effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks.
        • Must have a proven ability to communicate effectively in both a written and verbal format.
        • Ability to work both independently or collaboratively in a team structure.
        • Have a proven ability to work well under pressure.
        • Will be skilled to lead communications with FDA and regulatory agencies to facilitate review and approval of submissions.
        • Must possess an advance degree in sciences (PhD preferred) with 12 years or more of experience in pharmaceutical industry.
        • The ideal candidate will have strong experience in small molecule Regulatory CMC, as well as, late stage or commercial pharmaceutical development experience.
        • He/she must be detail oriented with strong leadership skills and excellent interpersonal and communication skills.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        188) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

        DESCRIPTION:

        • Design, develop and prototype pattern recognition, data collection and data processing algorithms
        • Use various software tools for processing and visualization of the experimental data
        • Work closely with interdisciplinary development team on acquisition and processing high quality data
        • Participate in digital signal processing algorithm development
        • Write documentation and white papers on algorithms, data processing and data presentation
        • Participate in definition of features, functionality and other software requirements

        EXPERIENCE AND QUALIFICATIONS:

        • Excellent written and oral communication skills
        • Experience in object oriented design and development
        • Knowledge of Linux and Windows operating systems
        • Experience in Qt and/or .NET frameworks
        • Familiarity with source code control tools preferably Mercurial (Hg)
        • Experience in grant proposal writing
        • MS/PhD in Computer Science, Math or Physics
        • Strong knowledge of pattern recognition and signal processing algorithms
        • Strong knowledge of statistics and data processing
        • Experience in MATLAB and Scilab
        • Experience in software development using C++ or other object-oriented language
        • Experience in data presentation and visualization

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        189) Senior/Associate Director Program Manager – Full Time or Contract (San Francisco Bay Area) P73BY

        DESCRIPTION:

        The Program Manager for the Molecular Diagnostics (MDx) Business Unit manages the development of internally developed diagnostics products or companion diagnostics products co-developed with external partners. This responsibility requires involving departmental or cross-functional teams focused on the delivery of new products. Plans and directs schedules and may monitor budget/spending. Monitors the project from initiation through delivery. Organizes the interdepartmental activities ensuring completion of the project/product on schedule and within budget constraints. Has overall project management responsibility. In this role, direct people management responsibility is not required.

        Essential Functions:

        • Leads cross functional core team through product launch
        • Develops project plan and timeline
        • Coordinates with external Assay Partner teams to achieve project / product deliverables
        • Be the internal expert in PCP process and IVD project management.
        • Act as “mini GM” as leader of cross functional core team.
        • Act as communication liaison with Business Unit Management to assure deliverables are met, appropriate resources are applied and team(s) remains focused and engaged

        Competencies:

        • Facilitative leadership skills, particularly the ability to influence stakeholders in other functions over whom the Project Manager has no direct authority. Must be a highly-motivated driver able to complete tasks by leveraging relationships and established goals.
        • Has analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations.
        • Willingness to be flexible and adaptable in a complex, matrixed environment. The ability to adapt to changing needs and parameters caused by time, budget, or other constraints
        • Discusses and presents factual information to other members of the team. Ability to convey very complex information in both written and oral form. Actively and constructively contributes to core team’s efforts through networking within the organization and effectively communicating to MDx management. Able to influence others and gain acceptance and build consensus.
        • Ability to manage moderately complex projects and initiatives.
        • Acts as a mentor/role model for team members.
        • Demonstrates understanding of company’s external customer needs and how they affect business unit products and services.
        • Makes decisions that involve the consideration of complex issues.
        • Works autonomously and checks-in as decisions are made.

        EXPERIENCE AND QUALIFICATIONS:

        • The candidate will have 3-5 years of project management experience in IVD product development
        • Experience with Device Design Control and biological/PCR based diagnostics is strongly desired
        • Working knowledge of design control and FDA QSR requirements
        • Microsoft Project Management skills
        • The candidate will have proven ability to execute through influence within a matrixed organization
        • The candidate will have an undergraduate degree in science or engineering. Additional advanced degrees are preferred but not required
        • In their repertoire, the candidate will be self-motivated & a driving force of execution in their current or past organizations
        • Experience working with external collaborators; Negotiations skills; Leading through influence
        • Strong written and verbal communication skills
        • Strong presentation skills
        • PMP certification is preferred

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        190) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

        DESCRIPTION:

        Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules and the ability to work independently in a team environment.

        Principal responsibilities include:

        • Perform laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
        • Perform, review and document laboratory quality control procedures.
        • Operate, maintain and troubleshoot laboratory equipment.
        • Prepare reagents required for laboratory testing.
        • Review, interpret and report patient results.
        • Independently identify and troubleshoot basic problems that adversely affect test performance.
        • Report all concerns of test quality and/or safety to the Supervisor or Safety Officer
        • Assist with final development of protocol and processes for a Laboratory Developed Test and perform other duties as assigned.

        EXPERIENCE AND QUALIFICATIONS:

        • Proven successful track record and comfortable with a start-up environment.
        • Must possess a valid California CLS license, generalist preferred.
        • Completion of a CLS training program at an accredited institution or clinical laboratory work experience within the last five years.
        • Possess working knowledge of local, state and federal laboratory regulations.
        • Computer skills a must, automation skills preferred.
        • Ability to analyze and problem solve basic issues that impact test performance.
        • Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
        • Must communicate effectively with coworkers and non-laboratory personnel
        • Able to integrate and apply feedback in a professional manner.
        • Able to manage daily test processing needs with high emphasis on quality.
        • Ability to work as part of a team.
        • Ability to perform repetitive tasks.
        • High volume laboratory experience preferred.
        • Training in molecular biology techniques preferred.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        191) Senior/Associate Director Program Manager – Full Time or Contract (San Francisco Bay Area) P73BY

        DESCRIPTION:

        The Program Manager for the Molecular Diagnostics (MDx) Business Unit manages the development of internally developed diagnostics products or companion diagnostics products co-developed with external partners. This responsibility requires involving departmental or cross-functional teams focused on the delivery of new products. Plans and directs schedules and may monitor budget/spending. Monitors the project from initiation through delivery. Organizes the interdepartmental activities ensuring completion of the project/product on schedule and within budget constraints. Has overall project management responsibility. In this role, direct people management responsibility is not required.

        Essential Functions:

        • Leads cross functional core team through product launch
        • Develops project plan and timeline
        • Coordinates with external Assay Partner teams to achieve project / product deliverables
        • Be the internal expert in PCP process and IVD project management.
        • Act as “mini GM” as leader of cross functional core team.
        • Act as communication liaison with Business Unit Management to assure deliverables are met, appropriate resources are applied and team(s) remains focused and engaged

        Competencies:

        • Facilitative leadership skills, particularly the ability to influence stakeholders in other functions over whom the Project Manager has no direct authority. Must be a highly-motivated driver able to complete tasks by leveraging relationships and established goals.
        • Has analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations.
        • Willingness to be flexible and adaptable in a complex, matrixed environment. The ability to adapt to changing needs and parameters caused by time, budget, or other constraints
        • Discusses and presents factual information to other members of the team. Ability to convey very complex information in both written and oral form. Actively and constructively contributes to core team’s efforts through networking within the organization and effectively communicating to MDx management. Able to influence others and gain acceptance and build consensus.
        • Ability to manage moderately complex projects and initiatives.
        • Acts as a mentor/role model for team members.
        • Demonstrates understanding of company’s external customer needs and how they affect business unit products and services.
        • Makes decisions that involve the consideration of complex issues.
        • Works autonomously and checks-in as decisions are made.

        EXPERIENCE AND QUALIFICATIONS:

        • The candidate will have 3-5 years of project management experience in IVD product development
        • Experience with Device Design Control and biological/PCR based diagnostics is strongly desired
        • Working knowledge of design control and FDA QSR requirements
        • Microsoft Project Management skills
        • The candidate will have proven ability to execute through influence within a matrixed organization
        • The candidate will have an undergraduate degree in science or engineering. Additional advanced degrees are preferred but not required
        • In their repertoire, the candidate will be self-motivated & a driving force of execution in their current or past organizations
        • Experience working with external collaborators; Negotiations skills; Leading through influence
        • Strong written and verbal communication skills
        • Strong presentation skills
        • PMP certification is preferred

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        192) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

        DESCRIPTION:

        • Design, develop and prototype pattern recognition, data collection and data processing algorithms
        • Use various software tools for processing and visualization of the experimental data
        • Work closely with interdisciplinary development team on acquisition and processing high quality data
        • Participate in digital signal processing algorithm development
        • Write documentation and white papers on algorithms, data processing and data presentation
        • Participate in definition of features, functionality and other software requirements

        EXPERIENCE AND QUALIFICATIONS:

        • Excellent written and oral communication skills
        • Experience in object oriented design and development
        • Knowledge of Linux and Windows operating systems
        • Experience in Qt and/or .NET frameworks
        • Familiarity with source code control tools preferably Mercurial (Hg)
        • Experience in grant proposal writing
        • MS/PhD in Computer Science, Math or Physics
        • Strong knowledge of pattern recognition and signal processing algorithms
        • Strong knowledge of statistics and data processing
        • Experience in MATLAB and Scilab
        • Experience in software development using C++ or other object-oriented language
        • Experience in data presentation and visualization

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        193) Licensed PM Shift Clinical Laboratory Scientist (CLS) Supervisor – Full Time Position (San Francisco Bay Area) J75SP

        DESCRIPTION:

        The PM Clinical Laboratory Scientist Supervisor is responsible for supervising Clinical Laboratory Scientists and Clinical Lab Assistants, performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures, and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask, flexibility with tasks and schedules, and the ability to work independently in a team environment.

        Principal responsibilities include:

        • Performance of laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
        • Performance, review and documentation of laboratory quality control procedures.
        • Operation and maintenance of laboratory equipment.
        • Preparation of reagents required for laboratory testing.
        • Review, interpretation and reporting of patient results.
        • Identifying and remedying problems that adversely affect test performance.
        • Reporting all test quality and safety concerns to the Laboratory Director or Safety Officer.
        • Preparing performing reviews on testing personnel within specified time-frames.
        • Tracking training and competency of testing personnel.

        EXPERIENCE AND QUALIFICATIONS:

        • A successful track record and comfortable with a start-up environment.
        • Must possess a valid California CLS license.
        • A minimum of six years of relevant laboratory experience.
        • Possess working knowledge of local, state and federal laboratory regulations.
        • Strong computer skills, and automation experience preferred.
        • Ability to analyze and problem solve basic issues that impact test performance.
        • Strong communication skills with the ability to maintain open communication with coworkers, non-laboratory personnel, and managers.
        • Previous supervisory skills a plus.
        • Work the PM shift (3:30-12:00 or 4:30PM to 1:00AM, still TBD).

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        194) Clinical Laboratory Scientists I (CLS I) Day and PM Shift Licensed Clinical Laboratory – Full Time Position (San Francisco Bay Area) T75PS

        DESCRIPTION:

        Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules and the ability to work independently in a team environment.

        Principal responsibilities include:

        • Perform laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
        • Perform, review and document laboratory quality control procedures.
        • Operate, maintain and troubleshoot laboratory equipment.
        • Prepare reagents required for laboratory testing.
        • Review and interpret intermediate patient test results.
        • Independently identify and troubleshoot basic problems that adversely affect test performance.
        • Report all concerns of test quality and/or safety to the Supervisor or Safety Officer

        EXPERIENCE AND QUALIFICATIONS:

        • Seeking an individual with a successful track record who must be comfortable in an expanding, fast-paced high complexity clinical laboratory.
        • The ideal candidate must:
          • Possess a valid California CLS license, generalist preferred.
          • Completion of a CLS training program at an accredited institution or clinical laboratory work experience within the last five years.
          • Possess working knowledge of local, state and federal laboratory regulations.
          • Computer skills a must, automation skills preferred.
          • Ability to analyze and problem solve basic issues that impact test performance.
          • Strong communication skills with ability to maintain open communication with internal employees, managers and customers as needed.
          • Communicate effectively with coworkers and non-laboratory personnel

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        195) Licensed Clinical Laboratory Scientist (CLS) Supervisor – Full Time Position (San Francisco Bay Area) MR75L

        DESCRIPTION:

        Responsible for supervising Clinical Laboratory Scientists and Clinical Lab Assistants, performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures, and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask, flexibility with tasks and schedules, and the ability to work independently in a team environment.

        Principal responsibilities include:

        • Performance of laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
        • Performance, review and documentation of laboratory quality control procedures.
        • Operation and maintenance of laboratory equipment.
        • Preparation of reagents required for laboratory testing.
        • Review, interpretation and reporting of patient results.
        • Identifying and remedying problems that adversely affect test performance.
        • Reporting all test quality and safety concerns to the Laboratory Director or Safety Officer.
        • Preparing performance reviews on testing personnel within specified time-frames.
        • Tracking training and competency of testing personnel.

        EXPERIENCE AND QUALIFICATIONS:

        • Seeking an individual with a successful track record who must be comfortable in an expanding, fast-paced high complexity clinical laboratory.
        • The ideal candidate must:
          • Possess a valid California CLS license.
          • A minimum of six years of relevant laboratory experience.
          • Possess working knowledge of local, state and federal laboratory regulations.
          • Strong computer skills, and automation experience preferred.
          • Ability to analyze and problem solve basic issues that impact test performance.
          • Strong communication skills with the ability to maintain open communication with coworkers, non-laboratory personnel, and managers.
          • Previous supervisory skills a plus.
          • Have strong molecular and troubleshooting experience, and a minimum of 6 years of experience.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        196) Clinical Laboratory Scientists I (CLS I) Day and PM Shift Licensed Clinical Laboratory – Full Time Position (San Francisco Bay Area) T75PS

        DESCRIPTION:

        Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules and the ability to work independently in a team environment.

        Principal responsibilities include:

        • Perform laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
        • Perform, review and document laboratory quality control procedures.
        • Operate, maintain and troubleshoot laboratory equipment.
        • Prepare reagents required for laboratory testing.
        • Review and interpret intermediate patient test results.
        • Independently identify and troubleshoot basic problems that adversely affect test performance.
        • Report all concerns of test quality and/or safety to the Supervisor or Safety Officer

        EXPERIENCE AND QUALIFICATIONS:

        • Seeking an individual with a successful track record who must be comfortable in an expanding, fast-paced high complexity clinical laboratory.
        • The ideal candidate must:
          • Possess a valid California CLS license, generalist preferred.
          • Completion of a CLS training program at an accredited institution or clinical laboratory work experience within the last five years.
          • Possess working knowledge of local, state and federal laboratory regulations.
          • Computer skills a must, automation skills preferred.
          • Ability to analyze and problem solve basic issues that impact test performance.
          • Strong communication skills with ability to maintain open communication with internal employees, managers and customers as needed.
          • Communicate effectively with coworkers and non-laboratory personnel

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        197) Paralegal/Contracts Associate – Part Time Position 20 Hrs/week (San Francisco Bay Area) YR90W

        DESCRIPTION:

        Will work under the direction of the Contracts Manager and will be primarily responsible for all contract management duties within the department. Responsible for preparing and executing signature of contracts including, confidential disclosure agreements, consulting agreements, master service agreements, SOW, and other contract types. Shall provide professional legal support; drafting, reviewing and negotiating standard form contracts. Will manage the contract lifecycle for all corporate contracts, organize and maintain contracts database, provide contract review, interpretation of contract terms, and provide contract status updates and tracking.

        • Personal commitment to the company mission and vision.
        • Ability to identify problems and creatively solve them.
        • Superior communication skills both written and verbal.
        • Exceptional organizational and negotiation skills and attention to details.
        • Capable of prioritizing, handling multiple projects simultaneously and the ability to meet strict timelines.
        • Ability to maintain a positive attitude in a fast pace environment.
        • Willingness to share knowledge and train.
        • Demonstrate flexibility and ability to work independently and in a team/collaborative environment.
        • Interpret, draft and negotiate standard form contracts.
        • Guide other business function/department members on company contracts process as required.
        • Work with and support maintenance of the Legal Department’s contract request and database systems.
        • Maintain the workflow, prioritize, and complete multiple concurrent tasks in the face of constantly changing and competing priorities.
        • Provide and/or coordinate advice to internal clients on contract matters.
        • Ensure business activities and contracts comply with internal policies and guidelines, and industry laws and regulations.
        • Manage patent and trademark portfolio and coordinate with outside counsel as needed.
        • Manage the contracts database.
        • Monitor and track the status of contracts to ensure completion.
        • Know when to escalate to executive management any conflicts arising from contracts.
        • Train internal teams on contract forms and procedures.

        EXPERIENCE AND QUALIFICATIONS:

        • A bachelor’s degree or paralegal certificate is preferred with three (3) to six (6) years of relevant experience required.
        • Experience with drafting and negotiating contracts in a pharmaceutical or biotech industry, highly preferred.
        • Thorough understanding of the contract process including contract evaluation, negotiation, approval, tracking and close-out.
        • Experience with or knowledge of intellectual property and data privacy contract issues, highly preferred.
        • Experience with or knowledge of Pharma contract issues that overlap with FDA/pharmaceutical regulation is desirable, but not required.
        • The ideal candidate will be flexible and willing to learn new procedures and skill sets.
        • Strong computer literacy (Word, Excel and contract databases knowledge).

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        198) Manager, Sr. Manager, Regulatory Affairs CMC – Contract or Full Time Position (San Francisco Bay Area) Q77AB

        DESCRIPTION:

        Expertise with biologics and/or small molecule experience is essential. Manage CMC aspects of domestic and international regulatory affairs for multiple commercial and clinical projects. Responsible for obtaining and interpreting global CMC regulations and guidance and providing regulatory advice to Quality and Manufacturing team members.

        Work closely with CMC teams, corporate partners, and contract manufacturing organizations to prepare complete and accurate CMC submissions and meet established timelines. Responsible for interaction with global Regulatory authorities to ensure acceptance, rapid review, and approval of marketing applications, supplements, Variations, clinical trial applications, and other filings which present CMC information. Demonstrated strong communication and submission/ personnel management skills are required.

        • Plan, manage, and oversee preparation, and submission of global CMC submissions, including marketing and clinical trial applications.
        • Ensure that CMC content is complete, well-written, and meets all relevant requirements. Assess proposed manufacturing changes for global impact, and provide strategic regulatory guidance for optimal implementation of changes.
        • Provide regulatory advice to technical operations departments based on knowledge of current requirements.
        • Manage interactions with FDA or other regulatory authorities for assigned projects.
        • Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.
        • May supervise one or more Associates.

        EXPERIENCE AND QUALIFICATIONS:

        • BA/BS degree in life sciences is required; advanced degree is a plus.
        • Required:
          • At least 5 years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of product lifecycle).
          • Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S. and/or Europe.
          • Experience in assessing post-marketing changes is critical.
          • Proven ability to lead cross functional CMC teams on projects and sub-teams.
          • Thorough understanding of relevant CMC drug development regulations and guidelines.
          • Outstanding interpersonal and communication (written and verbal) skills.
          • Proficiency with standard software programs (e.g., Word).
        • Preferred:
          • Proven ability to successfully interact with Regulatory Authorities.
          • eCTD experience is desirable.
          • Demonstration of effective skills in managing regulatory professionals.
          • Strong background in chemistry, molecular biology, or similar is desirable.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        199) (Senior) Reliability Engineer Manufacturing & Production/ Industrial Manufacturing – Full Time Position (San Francisco Bay Area) S62BA

        DESCRIPTION:

        The Reliability Engineer II/Senior Reliability supports individual contributor activities in the areas of Reliability and Maintenance Engineering. The position reports to the Senior Manager of Process

        Engineering in the Technology Department. The Reliability Engineering group’s mission is to maximize equipment availability through the deployment of Reliability Engineering best practices in equipment design, assessment of operating equipment health, and structured root cause analysis of failed equipment in order to enable the site to meet the needs of patients through sustained equipment reliability.

        Responsibilities:

        Development and implementation of the overall site Reliability strategy and program, and support the incorporation of this into the site Integrated Risk Management program. Development, execution, analysis and optimization of:

        • predictive and condition based maintenance and monitoring programs, including lubrication, vibration, thermography, motor circuit analysis, eddy current, ultrasound, and corrosion trending.
        • reliability-centered maintenance, design and spares programs to ensure reliable asset operations and an optimized maintenance cost structure.
        • asset lifecycle strategies to support reliable operations and integration of asset retirement into site business planning processes.

        Execute Maintenance Engineering activities:

        • Determination of component/equipment repair, replacement, and retirement strategies.
        • Development, review and approval of repair procedures.
        • Technical reviews for spare parts requirements and obsolete component replacements.
        • Development and review of maintenance procedures and practices.
        • Review and revision of engineering specifications.
        • Audits of maintenance-related suppliers.

        Other duties:

        • Complete analysis and reporting of equipment performance metrics, and identification and prioritization of asset improvements.
        • Execute failure and root cause analyses to identify failure modes and causes to provide technical assessments.
        • Develop and implement recommendations to mitigate identified reliability risks.
        • Develop and deliver reliability and maintenance training to site maintenance, operations, and technical personnel.
        • Identify, develop, and implement industry and company network best practices into the Reliability and Maintenance Engineering programs.

        EXPERIENCE AND QUALIFICATIONS:

        • Bachelors of Science in Mechanical, Chemical or Electrical Engineering with a minimum of 8 years of experience in a Reliability and Maintenance Engineering role.
        • Advanced engineering degree and/or certification in maintenance and reliability, experience with SAP Plant Maintenance module, and cGMP knowledge is desirable.
        • Demonstrate strong proficiency in Reliability Engineering principles and techniques, and the successful application/implementation of this knowledge.
        • Demonstrate effective communication and interpersonal skills with technical and non-technical personnel, including Operations, Maintenance, Technology, Quality and Senior Management.
        • Work collaboratively across departments and lead cross-functional teams in the development, implementation, and sustainment of an overall Site Reliability Program.
        • Experience in industrial or pharmaceutical manufacturing facilities, knowledge in the use of computerized maintenance management systems, and Level 2 certification in lubrication, vibration, thermography and motor circuit analysis is preferred.
        • 7+ to 10 years of relevant experience.
        • No management experience required.
        • Willingness to travel – occasionally.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        200) Equipment Maintenance Technician – Contract (Massachusetts) 73U0626

        DESCRIPTION:

        • Repair and maintain plant machinery and equipment such as agitators, pressure vessels and pumps.
        • Perform preventative maintenance and work order repairs, inspections and adjustments.
        • Repair or replace control devices such as switches, photo eyes, proximity sensors, pushbuttons, etc. as needed.
        • Responsible for 24-hour emergency maintenance service as scheduled.
        • Assist in monitoring all work being performed by outside contractors.
        • Participates in plant safety, health and environmental programs.
        • Ensure compliance of all work related activities in a fair, ethical, and consistent manner.
        • Maintain a professional courteous manner with all vendors, contractors, and fellow employees.
        • Special projects and other responsibilities as may be determined.

        EXPERIENCE AND QUALIFICATIONS:

        • Expertise and proficiency with basic office computer software, and the ability to learn how to effectively use maintenance software to input data and research parts.
        • The employee must regularly lift and/or move up to 50#.
        • Must be able to climb ladders and work at elevations.
        • Have at least 3 years experience with hydraulics, pneumatics, mechanics and basic electrical repair.
        • Ability to read and interpret documents and drawings.
        • Ability to write detailed repair reports as well as good verbal communication.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        201) Licensed Clinical Laboratory Scientist (CLS) Supervisor – Full Time Position (San Francisco Bay Area) MR75L

        DESCRIPTION:

        Responsible for supervising Clinical Laboratory Scientists and Clinical Lab Assistants, performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures, and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask, flexibility with tasks and schedules, and the ability to work independently in a team environment.

        Principal responsibilities include:

        • Performance of laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
        • Performance, review and documentation of laboratory quality control procedures.
        • Operation and maintenance of laboratory equipment.
        • Preparation of reagents required for laboratory testing.
        • Review, interpretation and reporting of patient results.
        • Identifying and remedying problems that adversely affect test performance.
        • Reporting all test quality and safety concerns to the Laboratory Director or Safety Officer.
        • Preparing performance reviews on testing personnel within specified time-frames.
        • Tracking training and competency of testing personnel.

        EXPERIENCE AND QUALIFICATIONS:

        • Seeking an individual with a successful track record who must be comfortable in an expanding, fast-paced high complexity clinical laboratory.
        • The ideal candidate must:
          • Possess a valid California CLS license.
          • A minimum of six years of relevant laboratory experience.
          • Possess working knowledge of local, state and federal laboratory regulations.
          • Strong computer skills, and automation experience preferred.
          • Ability to analyze and problem solve basic issues that impact test performance.
          • Strong communication skills with the ability to maintain open communication with coworkers, non-laboratory personnel, and managers.
          • Previous supervisory skills a plus.
          • Have strong molecular and troubleshooting experience, and a minimum of 6 years of experience.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        202) Senior Statistical Analyst/ Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) JM96B

        DESCRIPTION:

        Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.

        • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
        • Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
        • Performs data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
        • Review Data Management Plan, data validation plan and edit check specifications.
        • Interact with statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
        • Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
        • Recognizes inconsistencies and initiates resolution of data problems.
        • Acts as a liaison between statistical programming, subcommittees and project teams as needed.
        • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
        • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
        • Acts independently to determine methods and procedures on new assignments.
        • May provide guidance to other lower level personnel.
        • Generate and QC summary tables, data listings and figures for in-house analyses of study data or publications using SAS standard coding practices.
        • Validate work of other programmer/analysts at CRO or in-house.
        • Maintain complete and auditable documentation of all programming activities.
        • Works closely with biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP).
        • Create/acquire tools to improve programming efficiency or quality.
        • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

        EXPERIENCE AND QUALIFICATIONS:

        • Ability to use professional concepts to achieve objectives in creative and effective ways.
        • Experience in the analysis of complex Oncology clinical trial data.
        • Solid knowledge of CDISC standard (SDTM & ADaM).
        • Minimum 9 years Pharmaceutical/Biotech programming experience.
        • Experience working with Oncology trials required.
        • NDA submission experience is a plus.
        • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
        • BS/MS in Statistics, Math or Scientific Discipline.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        203) Associate Director/ Principal, Biostatistics – Full Time Position (San Francisco Bay Area) F96MP

        DESCRIPTION:


        DESCRIPTION:

        Responsible for designing, planning and conduct of clinical studies for a development molecule candidate. Contributes to technical and managerial leadership and organizational improvement. Responsible for providing leadership within the biostatistics department and making recommendations with regards to the strategic aspects of clinical studies as well as oversight of biostatistics activities.

        • Ensures that proper activities are undertaken for the timely and quality to meet corporate objectives.
        • Collaborates interdepartmental and scientific activities, especially collaboration with medical monitors on protocol design (author or supervisor statistical methods section and generate study randomization). 
        • Generate statistical analysis plan for assigned protocols (including mock displays).
        • Assume responsibility for individual studies, write statistical portion of integrated clinical/ statistical reports.
        • Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity.
        • Supply statistical input for NDA submissions and in response to FDA queries.
        • Provide support for investigator publications.
        • Review case report forms to ensure that protocol objectives are met and project standards are maintained.
        • Responsible for ensuring compliance with departmental and company goals.
        • Effectively communicates timely and relevant updates to all team members involved.
        • Expected to lead projects or direct reports, and is responsible for ensuring and overseeing the work of others including mentoring of staff on all assigned clinical studies.


        EXPERIENCE AND QUALIFICATIONS:

        • Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials.
        • Applies judgment and professional expertise independently.
        • Able to prioritize and handle multiple tasks simultaneously.
        • Prior management/supervisory experience (for Associate Director title).
        • 15 years related experience in clinical development in a pharmaceutical company. 
        • 2-5 years supervisory experience.
        • Previous experience with all phases of clinical research.
        • Previous experience in successful NDA.
        • Leadership in resource allocation, budget forecasting, project planning and implementation.
        • PhD in Biostatistics preferred.

        To apply for a position send your resume to Jobs@JGBBioPharma.com

        Back to Top

        linebreak

        Copyright © 2005-2014 JGB BioPharma Consulting Inc. All rights reserved.