Associate Director of Medical Writing

Job Summary

A company is looking for an Associate Director, Regulatory Medical Writing.

Key Responsibilities

• Lead all Medical Writing deliverable work for assigned compounds/indications
• Manage the work of both internal and outsourced Medical Writers
• Develop document strategy and timelines, ensuring adherence to regulatory guidelines

Required Qualifications and Education

• Bachelor's degree required; advanced degree preferred
• A minimum of 8 years of relevant Medical Writing experience
• Expert knowledge of the clinical research process and regulatory writing
• Proficiency in MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems
• Thorough understanding of ICH GCP guidelines