Offer summary
Qualifications:
Bachelor's degree, Minimum 7 years as regulatory writer, Experience with electronic Common Technical Document (eCTD), Strong understanding of FDA/ICH guidelines, Excellent technical and regulatory writing skills.
Key responsabilities:
- Author and manage clinical regulatory documents
- Coordinate medical writing resources and review processes
- Assist in document standardization and training
- Manage document preparation timelines and quality
- Support ad hoc projects like abstracts and posters