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Medpace

Global CRO delivering full-service clinical trials

Entry Level Regulatory Submissions Coordinator

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeTokyo, Japan

About the Job

Requirements

  • A Bachelor's degree in a relevant field or a Master's degree within Life Sciences.
  • Knowledge of local regulations regarding clinical studies and the conduct of such studies.
  • Strong communication skills.
  • Computer skills, including working knowledge of Microsoft Office applications.
  • Native-level Japanese (JLPT N1) and a minimum English TOEIC score of 500 or equivalent.

Responsibilities

  • Quality-check submission documents and site essential documents.
  • Interact with U.S. Central Institutional Review Boards, sites, and international associates.
  • Prepare and approve informed consent forms.
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges.

About the Company

Medpace

Global CRO delivering full-service clinical trials

Medpace is a global Contract Research Organization that provides end-to-end clinical development services for pharmaceutical, biotechnology, and medical device companies. It manages Phase I–IV trials from study design and regulatory submissions to monitoring, data management, biostatistics, and final reporting, using a single integrated team. A key differentiator is its ownership of integrated laboratories—global central labs, a bioanalytical lab, and imaging/ECG core labs—ensuring streamlined workflows and consistent data. Its physician-led, scientifically driven approach and single-vendor model aim to reduce sponsor oversight and help bring therapies to market efficiently, with operations in over 40 countries.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cincinnati, OH
Founded
1992

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