principal document specialist - Bengaluru - beBeeMedicalWriter

    beBeeMedicalWriter
    beBeeMedicalWriter Bengaluru

    1 day ago

    Job title: Assistant Manager

    Description

    Regulatory Medical Writer Position



    This is a professional role that requires expertise in medical writing, specifically in the area of regulatory submissions. The ideal candidate will have extensive experience in drafting and managing clinical documents such as Protocols, Investigators Brochures (IB), Informed Consent Documents (ICD), and other regulatory submission documents.



    Key Responsibilities:




    • Drafting and management of clinical documents such as protocols, investigators brochures, informed consent documents and other regulatory submission documents.

    • Preparation and review of key regulatory documents including non-clinical overview, clinical overview module 2.6 7 briefing packages document support etc.

    • Maintenance of high quality documentation to ensure compliance with internal standards and external regulatory guidelines cross-functional interaction with departments staff members etc.

    Required Skills and Qualifications:


    h4 class="MsoNormal" id="d1e765">Experience: A minimum of 10+ years as a professional medical writer ,with,Rigorous knowledge's,' detailed understanding
    of regulations,policies,guidelines applicable to Regulatory Medical Writing .
       , reglatory knowledge technical proficiency publication knowledge communication skills attention detail work ethic and ]

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