Associate Director Medical Writing

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 View email address on click.appcast.io. #J-18808-Ljbffr Meet Life Sciences