Lead Nonclinical Medical Writer

Job Summary

To support regulatory submissions, the contract Lead Nonclinical Medical Writer will manage the planning, development, and review of nonclinical regulatory documents while working remotely and collaborating with Sponsor teams and Acumen staff.

Key responsibilities

• Managing the planning, development, and review of various nonclinical regulatory documents, including INDs and NDAs
• Collaborating with Sponsor teams to gather necessary source information for document development
• Providing mentorship and guidance to internal writing teams while ensuring compliance with regulatory guidelines

Required qualifications

• A minimum of 3 to 5 years of experience in nonclinical document writing
• An advanced scientific degree, preferably a PhD, in the biological sciences
• Strong leadership and team management skills, including mentoring junior medical writers
• In-depth knowledge of regulatory requirements, guidelines, and standards (e.g., ICH, FDA, EMA)
• Experience with regulatory agency interactions is a plus