MSI Pharma have partnered with a leading pharmaceutical company seeking a Principle Medical Writer.
- More than 3 years of study related and submission related clinical regulatory documents
- Experience of writing protocols, CSRs, IBs, Briefing Documents
- Experience of writing relevant documents for more than 3 drug products in Oncology and Immuno-oncology
- Leading the delivery for individual documents, setting clear expectations for completion of assignments to expected timelines and quality.
- MSc or PhD in Life Science
- Understand the role of other functions in document development (e.g. statistics, clinical, regulatory, safety, etc.)
- Serve as a knowledgeable resource on regulatory requirements (eg, GCP, ICH, CTD) and relevant internal/external guidelines.
- Understand complex clinical study design and statistical concepts, terminology, and analyses within text and tables/figures.