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1) (Senior) Clinical Regulatory Scientist – Full Time Position (San Francisco Bay Area) E62QG
2) Sr Document Control Specialist – Full Time Position (San Francisco Bay Area) V55SS
1) (Senior) Clinical Regulatory Scientist – Full Time Position (San Francisco Bay Area) E62QG
DESCRIPTION:
Provides Regulatory Leadership to deliver a global regulatory strategy for highly complex products. Responsible for communication and teamwork with project team members/partners. Responsible for the development and implementation of regulatory strategies. Serves as the primary liaison with regulatory authorities and manages the strategy and execution of these interactions.
- Serves as the US Regulatory Leader on highly complex/business critical projects
- Serves as the regulatory representative on multiple projects and represents a complete regulatory strategy, including CMC and Commercial and leads the regulatory subteam
- Leads the lifecycle team and regulatory sub-team in developing, implementing and delivering a global regulatory strategy for highly complex products
- Provides regulatory due diligence assessments in cooperation with business development
- Presents regulatory strategies and issues at corporate committees/senior management
- Serves as the primary liaison with regulatory authorities
- Manage projects within a 6-12 month planning horizon
- Demonstrate leadership in defining novel approaches to product development and approval
- Collaborate with senior management on relevant long-term regulatory strategies
- Exerts influence in the development of overall objectives and long-range goals
- Lead cross-functional teams in the coordination of regulatory submissions
- Provide leadership in researching, recommending and implementing new processes in the department/company
- Continues to expand knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics
- Provides direction to Associates/Sr. Associates working on their projects through a matrix structure
EXPERIENCE AND QUALIFICATIONS:
- Bachelor’s degree required. Advanced degree preferred. Degree must be in a scientific discipline.
- Minimum of 10 years drug development in Regulatory Affairs or related experience
- Skills: strategic agility, ability to work well under pressure, influence at all levels without authority, strong interpersonal skills, relationship building, work in a team environment, flexibility and willingness to adapt in a changing environment.
- Demonstrate leadership, sound decision-making, negotiation and problem solving skills in an independent manner.
- Business knowledge and ability to be innovative and lead change
- Ability to travel occasionally
To apply for a position send your resume to Jobs@JGBBioPharma.com
2) Sr Document Control Specialist – Full Time Position (San Francisco Bay Area) V55SS
DESCRIPTION:
- Process documents through the electronic Controlled Document Management System (CDMS) using Documentum for the coordinator role. This includes word processing of documents and checking for format, spelling, grammar and punctuation, scanning documents and importing files.
- Train users in the use of CDMS in one-on-one and group settings.
- Create or update CDMS training materials and presentations as necessary.
- Assist users in the use of CDMS and provide users with Document Control support.
- Distribute controlled document hardcopies and an up-to-date document index to booksets.
- Publish and maintain an up-to-date controlled document index.
- Assist with troubleshooting issues, making improvements and change control for CDMS and work with users for implementation as required.
- Issue and maintain controlled logbooks.
- Issue controlled document hardcopies.
- Assign various control numbers in controlled logbooks.
- Maintain the Quality Assurance file room.
- Maintain the employee training binders.
- File employee training records, equipment temperature/humidity controlled charts, stability protocol amendments, vendor documentation, controlled logbooks and other documentation as required.
- Issue reports for biennial document currency reviews and monitor document change status.
- Manage the offsite storage for Quality Assurance documents and records.
- Provide metrics related to the document management process.
- Create and revise Document Control related SOPs, work instructions, lists, forms and logs as necessary.
- Act as the delegate for reviewing and approving Document Control related documents.
- Act as the back-up to represent Document Control during regulatory agency inspections and provide the necessary documentation as requested.
- Participate in internal audits of Document Control as necessary.
EXPERIENCE AND QUALIFICATIONS:
- Bachelor’s degree, preferably in Business Administration/Management, Computer Science or a Life Science.
- 5+ years of demonstrated experience in a Document Control role in the pharmaceutical and/or biotechnology industries. Experience in the medical device industry a plus.
- 3+ years of experience using an electronic document management system. Documentum experience is preferred.
- Must be proficient in using the Microsoft Office suite of products (Word, Excel, PowerPoint, Visio, Access and Outlook) and Adobe Acrobat.
- Working knowledge of FDA Regulations, including 21 CFR Parts 11, 210, 211 and 820.
- Strong organizational and written/verbal communication skills are essential.
- Must possess excellent proofreading skills to identify spelling, grammatical, punctuation and formatting errors for correction.
- Ability to develop and present training materials.
- No relocation provided.
To apply for a position send your resume to Jobs@JGBBioPharma.com
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