Nonclinical Medical Writer

Job Summary

Working remotely in a full-time capacity, the Nonclinical Medical Writer will manage the planning, development, and review of nonclinical regulatory documents to ensure accuracy, compliance, and timely completion for successful regulatory submissions.

Key responsibilities:

• Managing the development of various nonclinical regulatory documents, including Module 4 study reports and INDs
• Collaborating with Sponsor teams to gather necessary source information for document preparation
• Providing mentorship and guidance to internal writing teams while contributing to process improvement initiatives

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 writers
• In-depth knowledge of regulatory requirements and guidelines (e.g., ICH, FDA, EMA)
• Experience with regulatory agency interactions is a plus