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1) Director CMC Regulatory – Full time position (San Francisco Bay area) G62RF
2) Trial Transparency Manager – 6 month contract (New Jersey) 443
1) Director CMC Regulatory – Full time position (San Francisco Bay area) G62RF
DESCRIPTION:
The Regulatory CMC Director will provide Regulatory leadership and oversight to the team of ~ 3 regulatory professionals responsible for marketed product small molecules portfolio.
- Responsible for assuring timely compilation and management of all necessary documentation for regulatory submissions to support the CMC section of license applications, supplements, establishment registrations and regulatory compliance submissions. Ensure quality; content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs.
- Provide regulatory oversight for impact to change control, discrepancy management and inspection management systems. Participate in Quality Review Boards, Change Review Boards and any other relevant governance committees.
- Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities. 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.
- Reports to head of marketed products for small molecules. Collaborates with Operations, Quality Control, Validation, Technical Development and Technical Regulatory colleagues to assure product and regulatory expectations are met.
EXPERIENCE AND QUALIFICATIONS:
- A recognized industry leader in the CMC field.
- Demonstrated effective problem solving, strong understanding of regulatory strategies, 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 collaboratively in a team structure and proven ability to work well under pressure.
- Skilled to lead communications with FDA and regulatory agencies to facilitate review and approval of submissions.
- Advanced degree in science (PhD preferred) with at least 12 years or more of experience in pharmaceutical industry.
- Strong experience in Regulatory CMC, as well as: small molecule, development, manufacturing or quality assurance experience.
- Detail oriented with strong leadership/people management skills and excellent interpersonal and communication skills.
- May be required to travel to on a periodic basis.
To apply for a position send your resume to Jobs@JGBBioPharma.com
2) Trial Transparency Manager – 6 month contract (New Jersey) 443
DESCRIPTION:
In collaboration with the other members of the TT team, the Transparency Manager contributes to the public disclosure of clinical trial protocol information and results for clinical studies managed by the CSO SCP in line with regulatory requirements and company public disclosure strategy. More specifically, the Transparency Manager is in charge of preparing the scientific content to be posted on intranet websites based on the protocol and the study report. He/she needs to interact closely with the clinical/statistical study team as well as with other key functions such as regulatory, medical marketing, patents, legal, etc.
Depending on the type of studies, results will be disclosed either as an ICH E3 summary or in a very specific format requiring statistical figures to be entered in the ClinicalTrials.gov registration system managed by the National Health Institute. For a given study, he/she should ensure consistency of the information to be posted with already publicly disclosed information (e.g., medical publication, press release…) as well as with information submitted to Regulatory Authorities. He/she will work on all studies performed with the same compound in order to develop an expertise, collaborate more effectively with the project team and contribute to the scientific consistency between studies with the same compound.
- To manage disclosure of trial results: preparation of the information to be posted (ensuring consistency with available or on-going medical publication), review and approval processes and release the information on the appropriate website within the required timelines.
- To manage disclosure of protocol information: preparation of the reference protocol information to be disclosed (e.g. Trial Disclosure Form), review and approval processes. To ensure appropriate collaboration with Transparency Coordinator in charge of disclosure preparation in CRYSTAL and of initial release of the study on ClinicalTrials.gov within the required timelines.
- To support Transparency Coordinator and Assistant for the updates of on-going studies following protocol amendments or changes in monitoring information, as well as for the maintenance of the CRYSTAL database for tracking purposes.
- To manage some transversal activities such as: management of public requests received in the contact mailbox, elaboration of processes, development of new tools, etc.
- To follow pharmaceutical/medical/regulatory issues related to the transparency of clinical trial information.
- In collaboration with Transparency head, to ensure appropriate communication towards other functions, units.
Main Challenges:
- To ensure disclosure of quality information within the required timeframes. The Transparency Manager is deeply involved in the evaluation, elaboration of summary documents and data submissions for disclosure to the public.
- To negotiate with different functions in order to build consensus or an alternative and workable alternate solution as multiple points of view may need to be considered.
- To quickly understand the complex and dynamic/changing US and international environment of trial information disclosure.
EXPERIENCE AND QUALIFICATIONS:
- Thorough understanding of the clinical development environment
- Knowledge of statistical methodology in clinical studies and publication results
- Fluency in written and spoken English
- Ability to synthesis scientific information and edit text for specific audiences
- Quality consciousness and attention to detail
- Comfortable with computer applications
- Good sense of organization and prioritization
- Excellent interpersonal and communication skills
- Team player
- Technical skills: XML eXtensible Markup Language, Document Management System
- Must have experience in disclosure of clinical trial results
- Some exposure to oncology and diabetes studies would be helpful
- Scientific background (Bac +5, Masters degree, or equivalent professional experience) with training in statistics
- Several years of successful experience in a clinical development environment: biostatistics, medical writing, regulatory affairs
To apply for a position send your resume to Jobs@JGBBioPharma.com
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