Senior Director of Pharmaceutical Writing

Key responsibilities: Oversee the execution of pharmaceutical and biologic regulatory writing engagements, ensuring technical quality and timely delivery Independently author and lead complex clinical submission documents, including responses to regulatory authority questions Develop and communicate regulatory writing strategies while mentoring and providing oversight to writing staff

Required qualifications: Bachelor's degree or higher in life sciences, medicine, pharmacy, biomedical sciences, engineering, or a relevant scientific discipline 8+ years of pharmaceutical or biologic regulatory medical writing experience, including substantial hands-on authorship of complex submission documents 5+ years of medical device regulatory or clinical writing experience, specifically in leading end-to-end Clinical Evaluation Reports (CERs) Demonstrated ability to independently lead major pharmaceutical writing programs and manage multidisciplinary review teams Experience with eCTD-based pharmaceutical submissions and U.S. medical device regulatory documentation, including direct 510(k) authorship preferred