Director, Medical Writing
Send a job offer directly to this candidate
Results-driven, conscientious, consistently recognized high-performing regulatory medical writing professional for over 15 years, with 10 years preceding experience in drug safety/pharmacovigilance.
Demonstrated ability to work effectively on cross-functional teams to produce high quality deliverables across the clinical development lifecycle compliant with regulatory requirements/guidelines and corporate quality standards, including protocols and amendments, IBs, CSRs, CTD Module 2 summary documents, briefing documents, and DSURs. Served as lead medical writer for multiple regulatory submissions in rare disease/orphan drug indications, resulting in regulatory approvals.
Experience procuring and managing contracted (and internal) medical writing resources and leading/contributing to process improvement initiatives supporting best practices in medical writing.
MS, SUNY at Buffalo, Roswell Park Cancer Institute Graduate Division, 1996
BA, Biology and Psychology, Boston University, 1993
