Senior Medical Writer

Job Summary

Senior Medical Writer, responsible for managing aspects of a regulatory affairs medical writing program focused on supporting regulatory approval for medical devices, working full-time in a remote capacity.

Key Responsibilities

• Write, edit, and review clinical regulatory documents including Clinical Evaluation Plans and Post-Market Surveillance reports
• Perform systematic literature reviews and synthesize clinical evidence for regulatory submissions
• Collaborate with cross-functional teams to ensure high-quality submission-ready clinical documentation

Required Qualifications

• Bachelor's degree in Life Science, Biological Science, or related discipline
• 5 years of relevant experience in clinical medical writing within the life science industry
• Experience with EU MDR/MDD regulations
• Proficiency in Microsoft Office Suite and related software
• Ability to handle confidential regulatory and clinical documentation