Medical Writing Manager

Job Summary

Leading a team of medical writers, the full-time Sr. Manager, Medical Writing will manage the preparation of scientific and regulatory documents for client projects while ensuring timely delivery and adherence to quality standards in a remote setting.

Key responsibilities

• Provide leadership and management of the Medical Writing group, overseeing project timelines and deliverables
• Prepare and review regulatory documents across various phases, including clinical protocols, IND, NDA, and MAA submissions
• Ensure quality control and peer review of documents in compliance with standard operating procedures

Required qualifications

• Master's or doctorate degree in biological sciences or equivalent
• 10-15 years of experience in medical regulatory writing, with at least 8 years in the pharmaceutical/CRO industry
• Proven leadership experience managing a medical writing team
• Advanced proficiency in Microsoft Word and Adobe Pro
• Knowledge of medical terminology and the clinical trial process