Regulatory Submissions Coordinator - Osaka, Japan

				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.

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;
* 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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