Found Description
We are seeking two Clinical Writers to join a global project starting after the summer. The roles will be responsible for the development, review and delivery of high-quality clinical and non-clinical regulatory documents across multiple therapeutic areas, ensuring compliance with regulatory requirements, client standards and industry best practices.
Key Responsibilities
- Author, edit, and review a broad range of clinical and non-clinical regulatory documents, including:
- Clinical Study Protocols and Amendments
- Clinical Study Reports (CSRs)
- Investigator's Brochures (IBs)
- Clinical Summaries and Overviews
- Common Technical Document (CTD) Modules
- Non-clinical Study Reports and Summaries
- Integrated Summaries of Safety (ISS) and Efficacy (ISE)
- Regulatory briefing documents and responses to Health Authorities
- Interpret and present complex scientific, clinical, statistical, and...