Senior Regulatory Medical Writer

Job Summary

To advance their career in life sciences, the full-time Senior Regulatory Medical Writer will work remotely on a contract basis, serving as the primary author for Phase 1-3 regulatory documents and ensuring compliance with submission guidelines.

Key responsibilities

• Serve as primary author for clinical study protocols, protocol amendments, and Clinical Study Reports (CSRs)
• Research, author, and edit complex clinical documents, including Investigator's Brochures and IND applications
• Review peer and junior writer deliverables while providing mentorship on regulatory requirements

Required qualifications

• Bachelor's degree in a scientific discipline or equivalent formal qualification
• 5+ years of regulatory medical writing experience supporting clinical drug development
• Significant knowledge of global regulatory document development guidelines
• Exceptional data interpretation and medical writing skills
• Proficiency with document management systems and client templates