Associate Director of Medical Writing

Job Summary

To support the development of complex clinical and regulatory documents, the full-time Associate Director of Medical Writing will manage medical writing activities, ensure compliance with regulatory standards, and collaborate with cross-functional teams in a remote work environment.

Key responsibilities:

• Primary author of various regulatory documents, including protocols, IBs, and CSRs
• Engages subject matter experts to develop accurate and organized content for regulatory submissions
• Manages in-house medical writers and external vendors to ensure timely project delivery and inspection readiness

Required qualifications:

• Bachelor's degree in a scientific or clinical discipline; PhD preferred
• Minimum of 5 years of clinical/regulatory medical writing experience in pharma or biotech
• Fluent in American English, with strong writing and proofreading skills
• Experience with eCTD Module 2 and Module 5 writing for global marketing applications
• Basic understanding of drug development methodologies and regulatory guidance for medical writing