Principal Medical Writer

Job Summary

A company is looking for a Principal Medical Writer (Regulatory MW).

Key Responsibilities

• Lead the creation of high-quality regulatory medical writing documents, ensuring compliance and quality
• Serve as the primary author for clinical study reports, protocols, and other complex documents
• Provide training and mentorship to junior writers and assist in program management activities

Required Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred
• 8+ years of experience in regulatory medical writing projects
• Experience in the pharmaceutical or CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous
• Significant knowledge of document development guidelines and medical writing skills