Executive Director, Medical Writing

Role: Executive Director of Medical Writing leading strategic and operational functions across all product lifecycle stages in a biopharma setting. Responsibilities: oversee global development of regulatory and scientific documents (e.g., protocols, INDs, BLAs, safety reports), develop departmental goals, and partner cross-functionally with Regulatory Affairs, Clinical Development, Biometrics, and others; lead team development, resource planning, and vendor strategies to ensure high-quality submissions and compliance. Requirements: PhD/MD/PharmD or equivalent; 12+ years in medical writing within biotech/pharma, with significant leadership experience; deep knowledge of FDA, EMA, ICH regulations; proven success in supporting global regulatory submissions and organizational scaling. HighValue: biologics/cell therapies, global regulatory submissions (INDs, BLAs), lifecycle management, team leadership, strategic planning, and cross-functional collaboration. WorkSetup: hybrid or remote (West coast hours preferred).