Senior Medical Writer

Job Summary

A company is looking for a Senior Strategic Medical Writer who will lead and write clinical and regulatory documents for drug and/or device development.

Key Responsibilities

• Prepare clinical and regulatory documents for drug and/or device development
• Coordinate the review, approval, and quality control of clinical and regulatory projects
• Develop knowledge of US and international regulations and participate in tactical process improvements

Required Qualifications

• Bachelor's Degree or higher, preferably in a scientific discipline
• Minimum of 4+ years of experience in the bio-pharmaceutical industry
• Experience writing and editing clinical and regulatory documents following relevant guidelines
• Understanding of drug development, clinical research, and regulatory requirements
• Ability to oversee multiple projects and collaborate with cross-functional teams