Director of Medical Writing

Leading the advancement of the medical writing portfolio, the full-time Director of Medical Writing will oversee the authoring of clinical documentation and regulatory submissions while collaborating with cross-functional teams in a remote work environment.
Key responsibilities:

Lead the planning and authoring of complex clinical and regulatory documents, including trial protocols and study reports
Represent medical writing on internal teams and mentor junior writers while ensuring compliance with regulatory requirements
Drive the development and improvement of departmental processes, policies, and training initiatives

Required qualifications:

Bachelor's degree in science or a related area; Master's/advanced degree preferred
12+ years in clinical or regulatory medical writing in the biotech/pharma industry, with at least 10 years in regulatory Medical Writing
Oncology experience is required
Significant experience in writing critical clinical documents for major regulatory filings (NDA, BLA, MAA)
Proven experience managing cross-functional teams and overseeing the work of writers/CROs/vendors