Principal Medical Writer

Job Summary

To support a growing portfolio of clients, the full-time Principal Medical Writer will author high-quality medical writing deliverables, manage clinical program documents, and ensure compliance with regulatory standards while collaborating with cross-functional teams, primarily in a remote capacity.

Key responsibilities

• Independently author and edit various clinical and regulatory documents, ensuring quality and adherence to guidelines
• Manage clinical program documents and coordinate resources for medical writing and quality control deliverables
• Supervise and mentor less experienced medical writers while maintaining communication with clients and stakeholders

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 processes
• Proficiency in MS Word with strong project management skills
• Experience in relationship building and strategic collaboration on key business accounts