Regulatory Submissions Manager - Tokyo, Japan

Medpace Holdings, Inc.

Japan, Tokyo

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team. This position plays a key role inthe clinical trial managementprocess at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Efficiently manage and successfully execute all aspects of global project start-up;
  • Perform quality checks on submission documents and site essential documents;
  • Prepare and approve informed consent forms;
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
  • Present during bid defenses, general capabilities meetings, and audits.

Qualifications

  • Bachelor’s degree or Master's/PhD degree within Life Sciences and more than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
  • Strong oral and written communication skills.
  • Knowledge of pharmaceutical industry, International Conference on Harmonization guidelines, and FDA or applicable local regulations.
  • Possess thorough understanding of regulatory submissions activities;
  • Demonstrated ability to organize, instruct and supervise a team in the completion of multiple tasks/projects;
  • Bilingual Japanese and English.

Travel: Minimal

Job posted: 2023-12-18

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