Director of Clinical Medical Writing
Role: Director of Clinical Medical Writing responsible for leading the development and management of regulatory clinical documents for vaccine candidates in a fast-paced, biotech environment.
Responsibilities
- oversee medical writing processes
- manage contract writers
- generate key documents like protocols, IBs, informed consent forms, and clinical study reports
- develop SOPs and templates
- ensure compliance with global regulatory standards
- support BLA/NDA submissions
- collaborate with cross-functional teams
- manage timelines and budgets
Requirements
- Ph.D. or PharmD with 12+ years' experience in clinical research or biotech, particularly in vaccine development (Phases I-IV, post-marketing), with proven leadership in regulatory document authorship and management
- Strong expertise in clinical development processes, GxP compliance, and experience with Veeva Vault, Microsoft Office, and emerging AI writing tools is preferred
- High-value specifics: vaccine modality, clinical phases, US and international regulatory submissions, and experience managing vendor relationships
Location: San Carlos, CA or remote with hybrid work arrangement; some travel may be required.
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