Senior Director of Medical Writing

Job Summary

Leading scientific, medical, and regulatory writing activities, the full-time Senior Director of Medical Writing will oversee development projects, ensuring timely dissemination of clinical data and consistent messaging across functions while managing budgets and timelines in a remote setting.

Key responsibilities

• Oversee the full life-cycle support of scientific writing from clinical study protocols through regulatory submission
• Direct all clinical writing activities and manage the Medical Writing budget, resources, and vendor relationships
• Serve as a liaison between clinical functions to ensure accurate and strategic communication of clinical data and publications

Required qualifications

• Bachelor's/Master's degree in a scientific discipline; PhD preferred
• 15 years of experience in medical writing within pharmaceutical, biotech, or CRO environments
• 10 years of writing management experience and 12 years of supervisory experience
• Strong knowledge of regulatory functions, FDA and ICH guidelines, and CTD format
• Experience writing clinical protocols, investigator brochures, clinical study reports, and IND/NDA sections