Associate Director of Medical Writing

Job Summary

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

Key Responsibilities

• Manage all clinical writing activities outlined in the Project Clinical Development Plans
• Review documents, provide guidance, and lead the creation and management of document timelines
• Organize and lead document production meetings, ensuring compliance with departmental guidelines

Required Qualifications

• Bachelor's/Master's degree in a scientific discipline; PhD preferred
• Minimum of 10 years in a medical writing position, with at least 8 years in writing management
• Experience as a primary author of regulated documents and knowledge of FDA and ICH guidelines
• Strong analytical skills and ability to interpret statistical and clinical data
• Experience managing clinical trial registries such as CT.gov