Director, Medical Writing

Role: Lead medical writer responsible for developing and overseeing clinical regulatory documents for Lyell’s cell therapy pipeline, including protocols, amendments, Investigator’s Brochures, and clinical study reports, with the aim of supporting BLA submissions and eventual commercial launch. Responsibilities: authoring and managing core clinical documents, developing Module 2 content, vendor management, establishing medical writing processes, and implementing AI tools for efficiency. Also, potentially contributing to CMC technical writing and health authority briefing documents as the role evolves. Requirements: 10+ years in biotech/pharma medical writing with substantial experience in clinical regulatory documentation; strong expertise in protocol development, ICH guidelines, CTD/eCTD structure, and managing outsourced vendors; advanced degree in life sciences preferred. High-value: experience with cell or gene therapies (particularly CAR T), familiarity with accelerated pathways (e.g., RMAT), and knowledge of AI-assisted authoring in regulated environments. Stakeholders: partner closely with Regulatory and Clinical Development teams, report to VP of Regulatory Affairs. Work setup: not specified, likely hybrid or on-site given regulatory document management and vendor oversight.