Senior Manager, Medical Writing

Job Summary

A company is looking for a Senior Manager, Medical Writing.

Key Responsibilities

• Produce high quality and timely writing deliverables
• Independently plan, write, edit, and format key clinical documents
• Facilitate the review and finalization process for documents produced internally and externally

Qualifications

• Bachelor's degree in Life Science or English/Communications with relevant expertise; advanced degree preferred
• 6+ years of experience as a medical writer in a sponsor or CRO setting
• In-depth knowledge of Good Clinical Practices, FDA regulations, and ICH guidelines
• Successful track record of managing multiple projects in a fast-paced environment
• Experience with regulatory submissions and eCTD formatting is a plus