The Associate Director, Regulatory Writing plans, authors and manages regulatory/clinical documents to support clinical development programs and regulatory submissions. Manages contractors to prepare regulatory/clinical documents. The position is located in Palo Alto and reports to the Head of Regulatory Writing.
Key Responsibilities
- Plans, authors and manages clinical/regulatory documents, such as CSRs of all phases, Investigator Brochures CTD summaries, PIPs, briefing packages, responses to agency questions, and other document types as needed, according to ICH guidances, regulatory requirements and internal document standards.
- Represents Regulatory Writing on cross-functional project teams. Participates in regulatory teams, providing advice/guidance to the team on regulatory document requirements and optimal presentation of data
- Manages document timelines/resource planning.
- Works collaboratively with functional contributors (Clinical Development, Biometrics, etc.), ensuring all source information and data are appropriately reported in terms of accuracy, completeness, and scientific interpretation, and in accordance with project timelines.
- Coordinates the compilation of final documents and appendices provided by other functions
- Contributes to development of document and process standards, template development, and other aspects of document management.
- Manages the work of medical writing and other contractors to ensure document quality and adherence to timelines.
Contributes to other non-regulatory writing activities as needed
Requirements
- BA/BS and 10+ years of Regulatory Writing experience.
- Extensive experience in authoring, as well as managing contractors, to prepare clinical/regulatory documents as described above.
- Excellent verbal and written communication skills, and can effectively communicate with a variety of teams and individuals.
- Occasional business travel may be necessary.
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
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