Senior Medical Writer

Job Summary

Leading the medical writing team on Phase I-IV study documents, the full-time Senior Medical Writer will prepare protocols, informed consent documents, clinical trial reports, and other regulatory documents while working remotely across the US and Europe.

Key responsibilities

• Prepare and lead the medical writing team on various study documents in compliance with regulatory requirements
• Collaborate with other departments to develop Pre-IND documents and update them based on agency feedback
• Manage key document templates in accordance with global regulations and serve as the publishing point-of-contact for clinical trial reports

Required qualifications

• University/college degree in life sciences or a related field, or equivalent experience
• Minimum of 4 years of experience as a Medical Writer or in a similar role
• Thorough knowledge of applicable regulatory requirements and guidelines (e.g., ICH E3, E6, E9)
• Comprehensive skills in Microsoft Office, particularly Word, PowerPoint, Excel, and Outlook
• Excellent written and spoken English with strong project management and organizational skills