Regulatory Affairs Coordinator

Vor 4 Tagen


Zürich, Zürich, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

F. Hoffmann-La Roche Gruppe is dedicated to providing an inclusive and accessible environment for all candidates.

We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Switzerland.

Your Key Responsibilities :

  • Setting up and monitoring studies, completing reports, and maintaining documentation
  • Submitting protocol, consent documents for ethics/IRB approval, and preparing regulatory submissions
  • Taking responsibility for study cost efficiency
  • Preparation and review of study documentation and feasibility studies for new proposals
  • Potential to assist in training and mentoring fellow CRAs

Key Qualifications :

  • At least 2 years of monitoring experience in phase I-III trials as a CRA
  • Degree in medicine, science, or equivalent
  • Previous monitoring experience in medium-sized studies, including study start-up and close-out
  • Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
  • Excellent written and verbal communication in German, French, or Italian
  • Ability to work to tight deadlines
  • Availability to travel at least 60% of the time (international and domestic) and possess a valid driving license

Our Benefits :

We offer a competitive salary and a range of additional benefits, including annual leave entitlements, health insurance offerings, retirement planning options, and a global employee assistance program.



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