Associate Director of Medical Writing

A company is looking for an Associate Director of Medical Writing to contribute to the development of regulatory documents and enhance departmental infrastructure.

Key Responsibilities :

Primary author of various clinical and regulatory documents including protocols, IBs, and CSRs

Engages subject matter experts to ensure content is accurate and suitable for regulatory submissions

Manages medical writers and ensures inspection-readiness of medical writing activities

Required Qualifications :

Bachelor's degree in a scientific or clinical discipline required; PhD preferred

Minimum of 5 years of clinical / regulatory medical writing experience in pharma or biotech

Fluent in American English

Experience with eCTD Module 5 and Module 2 writing for global marketing applications

Basic understanding of scientific methodology in drug development