Principal Medical Writer

Job Summary

To support a growing portfolio of clients, the full-time salaried Principal Medical Writer will manage and author clinical program documents, ensuring compliance with regulatory standards while collaborating with cross-functional teams in a remote work environment.

Key Responsibilities

• Independently authors and manages a variety of clinical and regulatory documents, including protocols and study reports
• Leads cross-functional coordination of resources and manages client expectations, ensuring timely delivery of medical writing projects
• Supervises and mentors less experienced medical writers, fostering professional development within the team

Required Qualifications

• Bachelor's degree or higher in a medical or scientific discipline
• Minimum of 7 years of experience in writing clinical and/or regulatory documents for drugs, biologics, or medical devices
• Advanced knowledge of clinical research principles and regulatory submission requirements
• Proficiency in MS Word, including experience with tables, graphs, and figures
• Strong project management skills and ability to work independently with minimal supervision