Associate Director of Medical Writing

Job Summary

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