Senior Medical Writer - Verona - Orthofix

    Orthofix
    Orthofix Verona

    2 giorni fa

    A tempo pieno
    Descrizione

    Join our Clinical Affairs team as a Medical Writer based in Verona. We offer an excellent opportunity to develop global evidence-based clinical strategies for orthopedic medical devices by creating clinical documentation that synthesizes information from multiple data sources.

    In this role, you will work with cross-functional teams (Innovation, R&D, Regulatory & Quality, Sales & Marketing) at both local and international levels. You will engage with external consultants and regulatory agencies while collaborating on various projects assigned.

    • Review medical scientific literature
    • Analyze clinical risk and provide benefit/risk assessment

    You will write CERs/PMCF Reports utilizing your knowledge of ISO 14971 AIMDD MDD MDR MDCG CMDCAS/CMDR JPAL requirements. Additionally:

    • Write/edit reports ensuring compliance with international regulations



    • Collaborate on answering Notified Body or Regulatory Agency requests
    • Mentor/training new team members about procedures/best practices
      highlight the need for outside consultants/vendors/experts when necessary,hired via HCP/technical experts
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    Medical Writer

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    In this role you will work in a team environment to help develop global evidence-based clinical strategies for orthopedic medical devices by creating clinical documentation that systematically synthesizes information from multiple data sources. · ...

    Bussolengo 40.000 € - 45.000 € (EUR)

    1 mese fa

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Verona