Offer summary
Qualifications:
4+ years experience in clinical development, Strong understanding of ICH/E6/GCP guidelines, Experience authoring FDA submissions, Previous experience with biologics, Bachelor’s, Master’s or PhD in science/healthcare.Key responsabilities:
- Responsible for regulatory technical writing
- Support development of clinical documents
- Assist with US submissions and clinical trial applications
- Draft responses for multiple clients
- Provide expert advice based on regulatory data