Senior Director, Medical Writing Services

Job Summary

Leading the Pharmaceutical Writing Services group, the full-time Senior Director, Medical Writing Services will provide scientific and operational leadership for pharmaceutical and medical device writing engagements, ensuring the quality and delivery of complex clinical submission documents in a remote environment.

Key responsibilities

• Oversee technical quality and execution of pharmaceutical and biologic regulatory writing engagements, including authoring and leading complex Clinical Evaluation Reports (CERs)
• Develop and communicate regulatory writing strategies while guiding clients on regulatory updates and implications for documentation
• Mentor and provide oversight to writing teams, ensuring effective resource allocation and addressing delivery risks

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, with substantial EU MDR CER leadership experience
• Demonstrated end-to-end leadership of significant pharmaceutical submission programs or major clinical submission workstreams
• Experience substantially contributing to U.S. medical device regulatory submissions; direct 510(k) authorship is strongly preferred