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Regulatory Submissions Coordinator

Full-Time Tokyo, Japan
Health & Biotech
Health & Biotech
03 June 2024
Description
  • Quality check on submission documents and site essential documents;
  • Interaction with US Central IRBs, sites and international associates;
  • Preparation and approval of informed consent forms; and
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges.
Qualifications
  • A Bachelor's degree in a relevant field and at least 0.5 year of pharmaceutical research experience, or Master's degree within Life Sciences;
  • 1 - 3 years of work experience in a clinical trial environment;
  • Knowledge of local regulations regarding clinical studies and the conduct of such studies;
  • Strong oral and written communication skills;
  • Excellent computer skills, including a working knowledge of Microsoft Office applications.
  • Bilingual Japanese and English

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