Medical Writing Director
Barrington James🔬 Principal / Associate Director, Medical Writing | Remote (US) + Travel
Currently partnering with a rare disease biopharma seeking a Medical Writer to support major regulatory submissions and provide strategic leadership across development programs.
Seeking individuals with:
• Recent NDA, BLA, or MAA submission experience
• Strong CTD Module 2 authorship experience
• Submission leadership and cross-functional coordination experience
• Ability to balance hands-on writing and broader submission strategy
• Experience working with external vendors and CRO partners
This is a highly visible individual contributor opportunity with significant involvement in submission readiness and regulatory strategy.
If you or someone in your network may be interested, feel free to reach out and send me your updated resume. I’d be happy to provide additional details!