The role acts as a Lead Medical Writer responsible for preparing complex documents like Clinical Study Reports and protocols in accordance with IQVIA SOPs
Job Summary
The role acts as a Lead Medical Writer responsible for preparing complex documents like Clinical Study Reports and protocols in accordance with IQVIA SOPs.
Candidates must possess at least three years of highly relevant experience in regulatory writing and demonstrate the ability to identify deficiencies in statistical output.
The position involves senior-level responsibilities including negotiating timelines, resolving customer conflicts, and potentially acting as a Project Manager with finance duties.
Matching Summary
The role acts as a Lead Medical Writer responsible for preparing complex documents like Clinical Study Reports and protocols in accordance with IQVIA SOPs.
Skills & Requirements
Must-have
Bachelor's degree in life sciences
3+ years regulatory writing experience
Expertise in clinical study reports
Knowledge of Common Technical Documents
Ability to review statistical analysis plans
Nice-to-have
Master's or Ph.D. in life sciences
Experience with CTD preparation
Strong negotiation skills with customers
Ability to lead bid defense meetings
Willingness to draft new SOPs
Key Requirements
Bachelor's Degree in life sciences required
At least 3 years of regulatory writing experience
In-depth knowledge of GCP and drug development regulations