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    Associate Medical Writer - Zug, Schweiz - PSI

    PSI
    PSI Zug, Schweiz

    vor 6 Tagen

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    Ganztags
    Beschreibung

    Job Description

  • Writes, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
  • Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
  • Collects and tracks documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing
  • Critically assesses, interprets, and summarizes data from clinical studies
  • Reviews scientific literature pertinent to medical writing activities
  • Performs quality control (QC) reviews of PSI-developed Essential Documents and other documentation (in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing)
  • Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
  • Collaborates with the Process Improvement narrative automation team to develop patient safety narratives

    • Qualifications

  • College or university degree, preferably a Bachelor's/Master's degree in biomedical or life sciences fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities.
  • Minimum 2 years of corresponding industry experience working with clinical documentation and data
  • Prior pharmaceutical, biotechnology, or contract research organization experience
  • Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
  • Basic knowledge of electronic Common Technical Document (eCTD) requirements

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