MSI Pharma have partnered with a leading pharmaceutical company seeking a Principle Medical Writer.
Experience
* 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.
Qualifications
* 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.
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