Associate Director, Medical Writing (Hybrid - SF Bay Area)
We are seeking an experienced Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory documents in support of complex drug development programs. This individual will play a key role in shaping document strategy, ensuring scientific accuracy, and driving cross-functional alignment across clinical, regulatory, and biostatistics teams.
This is a hybrid role based in the San Francisco Bay Area. Relocation package is available.
Key Responsibilities
- Lead the planning, authoring, and review of clinical and regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures (IBs), and submission documents
- Serve as the medical writing lead on complex, multi-phase programs, including late-stage development and regulatory submissions
- Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations to ensure aligned messaging and data interpretation
- Drive document strategy and timelines to support IND, NDA, and other global regulatory submissions
- Ensure all documents meet regulatory requirements, internal standards, and industry best practices
- Manage external medical writers and vendors as needed
- Provide mentorship and guidance to junior writers and cross-functional team members
- Contribute to process improvements and development of templates, style guides, and best practices
Qualifications
- PhD (or equivalent advanced degree) in life sciences, pharmacy, or a related field required
- 8+ years of medical writing experience within biotech, pharma, or CRO environments
- Demonstrated experience supporting complex clinical development programs and regulatory submissions (IND, NDA, BLA, etc.)
- Strong expertise in authoring clinical and regulatory documents (e.g., CSRs, protocols, IBs)
- Proven ability to manage multiple writing projects and timelines in a fast-paced environment
- Excellent written and verbal communication skills, with strong attention to detail
- Experience working in cross-functional teams and influencing without direct authority
- Prior leadership or mentoring experience preferred
If this role sounds of interest, please reach out to tanya.kochan@meetlifesciences.com.
