Senior Medical Writer

Job Summary

Working full-time, the Senior Medical Writer will author and edit high-quality medical writing deliverables across various therapeutic areas, supervise junior writers, and manage client interactions while adhering to regulatory standards, all in a remote environment.

Key responsibilities

• Authors and edits clinical, safety, and regulatory documents with minimal supervision
• Supervises and mentors less experienced medical writers as necessary
• Manages client expectations and leads team meetings to ensure timely delivery of projects

Required qualifications

• Bachelor's degree or higher in a medical or scientific discipline
• Minimum of 5 years of experience in writing clinical and/or regulatory documents
• Advanced knowledge of FDA regulations and regulatory submission processes
• Proficiency in MS Word, including the ability to work with tables, graphs, and figures
• Strong project management skills and experience in relationship building with clients