Entry Level Regulatory Submissions Coordinator, Tokyo
Core
Full-time Regulatory Submissions Coordinator supporting clinical trial management and site activation in Japan.
Role type
Entry-level Regulatory Submissions Coordinator
Builds
Clinical trial submission packages and regulatory documentation for biotech/pharma clients
Domain
Clinical Research / Life Sciences
Required skills
Regulatory knowledge, document quality assurance, informed consent form preparation, stakeholder interaction, Microsoft Office, Japanese (native/JLPT N1), English (TOEIC 500+)
Preferred skills
Master's degree in Life Sciences, experience with local clinical study regulations
Technologies
Microsoft Office
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; Review pertinent regulations to develop proactive solutions to start-up issues and challenges.
Seniority
Entry Level, New Grad