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    Junior/Senior Medical Writer - England, United Kingdom - MSI Pharma

    MSI Pharma
    MSI Pharma England, United Kingdom

    Found in: Jooble UK O C2 - 1 day ago

    Default job background
    Description
    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.
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