Regulatory Submissions Coordinator

2ヶ月前

Tokyo Medpace

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position plays a key role in the clinical trial management process 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.

We offer the following:

  • Customized training program;
  • Hybrid work style and adaptable working hours;
  • Annual company bonus;
  • Annual merit salary increases;
  • Defined Contribution Plan;
  • Group term life insurance;
  • Insurance association benefits available;
  • Clear pathways for career growth, with opportunities to step into leadership roles;
  • Collaboration with a diverse, international team and gain global exposure;
  • Many additional perks unmatched by other CROs

Responsibilities

  • 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;
  • 0 - 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

Travel: Minimal
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,900 people across 40+ countries.

Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

  • Flexible work environment
  • Competitive compensation and benefits package
  • Competitive PTO packages
  • Structured career paths with opportunities for professional growth
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives

Awards

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What To Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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