Senior Medical Writer - MA Licensed

Job Summary

Leading the authorship of aggregate safety reports, the full-time Senior Medical Writer - MA Licensed will interface directly with clients on smaller projects while supporting larger engagements, contributing to the safety service line in a remote work environment.

Key responsibilities

• Author and manage a variety of aggregate safety reports, including DSURs, PSURs, and RMPs
• Serve as the project lead for smaller projects, coordinating with clients and internal teams
• Support larger projects by collaborating with cross-functional teams to ensure compliance with regulatory guidelines

Required qualifications

• Bachelor's degree or higher in a scientific discipline strongly preferred
• 2 to 5+ years of regulatory writing experience, specifically in aggregate safety report writing
• Proven understanding of regulatory authority guidelines and the drug development lifecycle
• Experience developing various safety reports, including PBRERs and PADERs
• Proficiency in Microsoft Word and document management techniques