Regulatory Submissions Manager - Tokyo, 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:

* 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
			

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