Medical Content Specialist

Vor 3 Tagen


Zug, Zug, Schweiz PSI Vollzeit

Job Summary

We are seeking a highly skilled Medical Content Specialist to join our team at PSI.

Key Responsibilities

  • Develop, edit, and review Essential Documents, including informed consent forms and clinical study reports.
  • Critically assess and interpret data from clinical studies, summarizing key findings for submission to regulatory agencies.
  • Collaborate with the Process Improvement narrative automation team to develop patient safety narratives.
  • Perform quality control reviews of PSI-developed Essential Documents and other documentation.

Requirements

  • A Bachelor's or Master's degree in biomedical or life sciences fields, or a relevant combination of education, training, and experience.
  • Minimum 2 years of experience working with clinical documentation and data, preferably in the pharmaceutical or biotechnology industry.
  • Basic knowledge of global regulations and guidelines, including FDA and ICH requirements.
  • Basic knowledge of electronic Common Technical Document (eCTD) requirements.


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