Director of Medical Writing

Role: Director of Medical Writing responsible for managing medical writing staff and developing departmental infrastructure within a clinical-stage biopharma focused on immunology and autoimmune diseases. Responsibilities: oversee in-house, contractor, and vendor medical writers; author key regulatory documents including protocols, IBs, CSRs, IND/BLA modules, and scientific advice briefing packages; ensure documents meet internal standards and regulatory requirements; facilitate document standardization, inspection readiness, and cross-functional collaboration; mentor team members and contribute to departmental strategy and corporate objectives. Qualifications: Bachelor’s degree in a scientific or clinical field, Ph.D. preferred; 7+ years of pharma/biotech medical writing experience, including leadership and management of direct reports or external writers; proficiency in eCTD modules, regulatory guidelines, and clinical development processes. HighValue: experience in global regulatory submissions, understanding of drug development phases, strong scientific and technical writing skills, leadership in a fast-paced environment, and fluency in American English. WorkSetup: not specified.