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 ResponsibilitiesLead the planning, authoring, and review of clinical and regulatory documents, including clinical study reports (CSRs), protocols, investigator brochures (IBs), and submission documentsServe as the medical writing lead on complex, multi-phase programs, including late-stage development and regulatory submissionsCollaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations to ensure aligned messaging and data interpretationDrive document strategy and timelines to support IND, NDA, and other global regulatory submissionsEnsure all documents meet regulatory requirements, internal standards, and industry best practicesManage external medical writers and vendors as neededProvide mentorship and guidance to junior writers and cross-functional team membersContribute to process improvements and development of templates, style guides, and best practicesQualificationsPhD (or equivalent advanced degree) in life sciences, pharmacy, or a related field required8+ years of medical writing experience within biotech, pharma, or CRO environmentsDemonstrated 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 environmentExcellent written and verbal communication skills, with strong attention to detailExperience working in cross-functional teams and influencing without direct authorityPrior leadership or mentoring experience preferredIf this role sounds of interest, please reach out to tanya.kochan@meetlifesciences.com.