Principal Medical Writer

Job Summary

Leading the preparation of clinical and regulatory documents, the full-time remote Principal Medical Writer will manage document authoring, coordinate team reviews, and ensure compliance with regulatory standards in drug and device development.

Key responsibilities:

• Independently prepares clinical and regulatory documents for drug and device development
• Coordinates review processes and conducts meetings with team members to ensure quality control
• Develops and implements project management strategies to meet submission objectives

Required qualifications:

• Minimum of 5+ years of experience in the bio-pharmaceutical industry
• Bachelor's Degree or higher in a scientific discipline preferred
• Extensive experience writing clinical and regulatory documents following ICH and GCP guidelines
• Advanced understanding of drug development, clinical research, and regulatory requirements
• Proficient in analyzing complex data and communicating scientific information effectively