Associate Director Medical Writing (Hayward)

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 [email protected].