Sr. Director, Medical Writing

Role: Senior Director, Medical Writing leading strategic medical documentation for biopharma drug development programs, ensuring regulatory compliance and strategic alignment. Responsibilities: develop and oversee clinical and regulatory documents (protocols, CSRs, IND/NDAs, PIPs, etc.), lead writing strategy, manage external vendors, mentor staff, and support inspection readiness. Requirements: Bachelor's in life sciences, 12+ years in medical writing within biotech/pharma, with experience managing teams and external vendors; strong knowledge of drug development, ICH, GCP, CTD, and global regulatory standards. HighValue: focus on early to late-stage clinical development, global submissions (INDs, NDAs, BLAs, MAA), regulatory documents, with expertise in biologics or small molecules preferred; 10-20% travel. WorkSetup: not specified.