Director, Medical Writing

Role: Lead medical writing for a biopharma company focused on cortisol-related therapeutics, supporting clinical and regulatory submissions. Responsibilities: serve as medical writing SME for strategies and document development, author and critically edit NDAs, protocols, CSRs, Investigator’s Brochures, and other regulatory materials; oversee in-house staff, vendors, and contractors; develop medical writing processes, SOPs, and quality control standards; mentor team members; collaborate with cross-functional teams to ensure document accuracy, completeness, and compliance with US and international regulatory guidelines. Requirements: BA/BS in a scientific field; 10+ years of regulatory medical writing experience in pharma, with team management and extensive clinical/regulatory document expertise; proficient in US/EU regulatory standards, electronic document management systems, and MS Office; excellent scientific writing, communication, and multitasking skills. Preferred: advanced scientific degree (PhD, PharmD, MS). High-Value: experience in drug development, regulatory submissions (NDAs, INDs), cross-functional collaboration, and global regulatory standards. WorkSetup: headquarters-based; salary range $183,500-$242,800; US work authorization required.