Medical Writer Associate

vor 4 Wochen


Zug, Zug, Schweiz PSI Vollzeit

Job Summary

We are seeking a highly skilled Medical Writer Associate to join our team at PSI. As a Medical Writer Associate, you will be responsible for writing, editing, and reviewing Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation.

Key Responsibilities

  • Write, edit, and review Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
  • Write, edit, review, finalize, and track clinical study report (CSR) patient safety narratives
  • Collect and track documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing
  • Critically assess, interpret, and summarize data from clinical studies
  • Review scientific literature pertinent to medical writing activities
  • Perform 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)
  • Act as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
  • Collaborate 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

About PSI

PSI is a leading provider of clinical documentation and data management solutions. We are committed to delivering high-quality services that meet the needs of our clients.



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