Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer (Remote).

Key Responsibilities

• Manage specific aspects of the Regulatory Affairs Medical Writing program to support regulatory approval for medical devices
• Write, edit, and review clinical regulatory documents including Clinical Evaluation Plans and Post-market Surveillance reports
• Collaborate with cross-functional teams to ensure preparation of high-quality submission-ready clinical documents

Required Qualifications

• Bachelor's degree in Life Science, Biological Science, or related discipline required; advanced degree preferred
• 5 years of relevant experience in clinical medical writing within the life science industry required
• EU MDR/MDD experience required
• American Medical Writing Association certification or similar preferred
• Clinical or statistical experience required