The role acts as a Lead Medical Writer responsible for preparing complex documents like Clinical Study Reports and Common Technical Documents in accordance with SOPs
Job Summary
The role acts as a Lead Medical Writer responsible for preparing complex documents like Clinical Study Reports and Common Technical Documents in accordance with SOPs.
Candidates must possess significant experience in regulatory writing with the ability to interpret statistical data and identify deficiencies in protocols.
The position involves senior review of deliverables, guiding junior staff, and potentially acting as a Project Manager with budgeting responsibilities.
Matching Summary
The role acts as a Lead Medical Writer responsible for preparing complex documents like Clinical Study Reports and Common Technical Documents in accordance with SOPs.
Skills & Requirements
Must-have
Bachelor's degree in life sciences
3+ years regulatory writing experience
Expertise in clinical study reports and CTDs
Strong statistical analysis interpretation skills
Ability to negotiate timelines with customers
Nice-to-have
Master's or Ph.D. in life sciences
Experience designing training materials
Project management and finance responsibilities
Cross-functional initiative leadership
Diplomatic conflict resolution skills
Key Requirements
Bachelor's degree in life sciences required
Minimum 3 years highly relevant regulatory writing experience
In-depth knowledge of GCP and drug development regulations