Associate Director of Medical Writing

Job Summary

A company is looking for an Associate Director, Medical Writer.

Key Responsibilities:

• Lead projects, submissions, and documentation for programs independently while collaborating with managers and other functions
• Provide medical writing strategy to program teams and author key clinical, nonclinical, and regulatory documents
• Represent the medical writing function in cross-functional teams and advocate for best practices in Medical Writing

Required Qualifications, Training, and Education:

• Bachelor's degree in a scientific discipline; advanced degree (MS, PhD, MD, PharmD) is a plus
• A minimum of 8+ years of experience in relevant regulatory medical writing
• Proven track record of program- and/or submission-level management
• Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements
• Expert in word processing software and document management systems