Principal Medical Writer

Job Summary

Managing clinical program documents for assigned clients, the full-time Principal Medical Writer will independently author high-quality medical writing deliverables, coordinate cross-functional resources, and ensure timely completion of projects while working remotely.

Key responsibilities

• Independently authors and edits clinical, safety, and regulatory documents across various therapeutic areas
• Manages client expectations and leads team meetings to ensure project timelines are met
• Supervises and mentors less experienced medical writers, ensuring adherence to regulatory standards

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 with strong project management skills
• Experience in building relationships and collaborating with cross-functional teams