Principal Medical Writer

Job Summary

Managing clinical program documents, the full-time Principal Medical Writer will independently author and oversee high-quality medical writing deliverables for drugs and medical devices, while collaborating with cross-functional teams in a hybrid work environment.

Key responsibilities

• Independently authors and edits clinical and regulatory documents, ensuring adherence to established guidelines
• Manages and coordinates medical writing deliverables, including supervising and mentoring less experienced writers
• Maintains communication with clients and internal teams, managing expectations and project timelines effectively

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, and/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 in a collaborative environment