Principal Regulatory Writer

Job Summary

Supporting all aspects of regulatory submissions writing needs, the temporary Principal Regulatory Writer will collaborate with senior management to craft compliant documents for global health authorities while working remotely.

Key responsibilities

• Craft clear and compliant regulatory documents, including clinical trial protocols, Investigator Brochures, and Clinical Study Reports
• Ensure all written materials adhere to regulatory guidelines and industry standards while analyzing complex scientific information
• Manage medical writing projects, developing timelines and maintaining communication with cross-functional teams to ensure document accuracy

Required qualifications

• Bachelor's degree with 15 to 20 years of relevant experience; advanced degree in science or medical field is a plus
• Experience with common regulatory documents such as CSRs, IBs, and eCTD modules
• Proven experience with marketing applications including INDs, BLAs, and NDAs
• Expert understanding of eCTD structure and clinical development processes, along with knowledge of ICH guidelines and GxPs
• Proven ability to manage complex projects and influence cross-functional teams