Senior Medical Writer Consultant

Job Summary

A company is looking for a Senior Medical Writer - Protocol Amendment Consultant.

Key Responsibilities

• Author and revise clinical trial protocol amendment text, focusing on pharmacy/IMP management
• Interpret complex clinical requirements into clear, regulatory-compliant language for site staff
• Collaborate with internal pharmacists and clinical staff to validate instructions and ensure operational feasibility

Required Qualifications

• 5+ years of clinical/regulatory medical writing experience
• Proven experience in authoring protocol amendments, particularly for pharmacy/IMP sections
• Familiarity with CAR-T or advanced therapy protocols preferred
• Ability to work independently and collaborate with cross-functional teams
• Exceptional writing, editing, and critical thinking skills for compliant documentation