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Medical Research Scientitst - Clinical Evaluation Report Writer - Oferta z Jobs.pl

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Medical Research Scientitst - Clinical Evaluation Report Writer

Nr ref.: /JOBS.pl

  • This position is
    responsible for producing Clinical Evaluation Reports using the MEDDEV 2.7.1
    guideline and new European Regulation. In liaison with NAMSA Clinical & Consulting
    team and clients, under the responsibility of the Manager Europe, Regulatory,
    Quality, Biological Safety and Validation services, this position will be
    responsible for preparing Clinical Evaluation Plans and Reports to support CE
    mark of devices :

    ü Preparation of Clinical Evaluation Plan
    for literature evaluation

    ü Understand device clinical use and associated
    treatments and therapies

    ü Analysis of equivalent devices

    ü Search for relevant publications in
    appropriate international databases

    ü Selection and Appraisal of identified publication

    ü Preparation of final Clinical Evaluation

    communication with clients (across Europe) and consultants are expected so
    fluent reading, speaking and writing English is required. Also, this position calls
    for significant medical writing to
    summarize key information and present outcomes in a scientific and accessible
    manner to authorities, always compliant with NAMSA Standard Operating
    Procedures and in full observance of the project planning and delivery date.

    Compétences requises:

    ü PhD in Biology, or Pharmacist, or Medical
    School Engineered,

    ü Training as a Clinical Research Associate
    welcome but not mandatory

    ü High level in English

    ü Interest in working in International

    ü Strong respect on quality of deliverables
    and due dates

    ü Ability to work in team but with high
    level of autonomy


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