Senior Director of Medical Writing

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