The Medical Writer is responsible for independently authoring high-quality clinical documents, particularly Module 2.5 and Module 2.7, for global regulatory submissions
Job Summary
The Medical Writer is responsible for independently authoring high-quality clinical documents, particularly Module 2.5 and Module 2.7, for global regulatory submissions.
This role involves close collaboration with Clinical Directors across multiple therapeutic areas to ensure scientifically sound, compliant, and timely delivery of clinical modules.
The position requires strategic planning with Global Labeling to develop an annual plan for clinical documentation supporting product renewals, safety updates, and regulatory maintenance activities.
Matching Summary
The Medical Writer is responsible for independently authoring high-quality clinical documents, particularly Module 2.5 and Module 2.7, for global regulatory submissions.
Skills & Requirements
Must-have
Authoring clinical modules 2.5 and 2.7
Global regulatory submissions
ICH guidelines
Cross-functional collaboration
Planning medical writing activities
Health Authority query responses
Nice-to-have
Familiarity with therapeutic areas
Collaboration with Global Labeling
Subject Matter Expert in processes
Key Requirements
Minimum 5 years industry experience as Medical Writer
At least 3 years medical writing in submission development