Principal Regulatory Medical Writer

Job Summary

Managing clinical program documents, the full-time Principal Regulatory Medical Writer will author high-quality medical writing deliverables, ensure project communication, and lead cross-functional coordination while working remotely.

Key responsibilities

• Independently author and edit clinical and regulatory documents, ensuring compliance with established standards and guidelines
• Manage client expectations and deliverable timelines while coordinating with internal resources and subject matter experts
• Supervise and mentor less experienced medical writers, providing guidance on project-related tasks and quality control

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 FDA regulations and regulatory submission requirements
• Proficiency in MS Word, including skills in managing tables, graphs, and figures
• Strong project management skills with the ability to work independently and collaboratively