Senior Director of Pharmaceutical Writing

Job Summary

Leading a team of pharmaceutical writers, the full-time Senior Director of Pharmaceutical Writing will provide scientific and operational leadership for complex regulatory writing engagements, including authoring Clinical Evaluation Reports (CERs) and overseeing client relationships in a remote environment.

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