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Medical Writing Manager

Virtual Vocations Inc · New York, NY, USA ·

Job type:
Full Time

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