Regulatory Submissions Coordinator

				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 5,000 people across 40+ countries.

Responsibilities:

* Prepare, review, and file clinical trial applications
* Communicate with research sites (hospitals, etc.) to collect all essential documents required before the site starts to enrol patients to participate in the clinical trial; 
* Provide insightful input on regulatory submissions documents and maintain timelines for study start-up through both internal and external collaboration;
* Ensure submissions comply with applicable regulations and guidance documents;
* Advise on changing country regulations and compliance requirements; and
* Track submissions and ensure timely filing of documents.

Qualifications:

* Bachelor's degree in a Life Sciences field;
* Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies;
* Full professional proficiency in English
* Interest in drug development and clinical trials;
* Knowledge of Microsoft(r) Office; and
* Excellent organization and communication skills, great attention to detail.
			

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Medpace, Inc.

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