Senior Medical Writer

Job Summary

A company is looking for a Senior Medical Writer to provide medical writing and scientific services for regulatory compliance.

Key Responsibilities

• Prepare clinical evaluation reports for regulatory submissions
• Assist in preparing responses to regulatory agencies regarding clinical information
• Manage multiple writing/research projects while ensuring compliance with FDA and ISO guidelines

Required Qualifications

• Master's Degree in a related field from an accredited institution
• 5 years of Medical/Technical writing experience
• Experience in systematic literature review
• Experience with EU MDR-compliant post-market reporting preferred
• Understanding of biostatistics preferred