Director of Medical Writing

Job Summary

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