Experienced Study Start Up 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 for France;
* Prepare and submit responses to queries and amendments to clinical trial applications;
* Ensure submissions comply with applicable regulations and guidance documents;
* Advise team members on changing regulations and compliance requirements;
* Maintain the Clinical Trial Management System and ensure timely filing of documents;
* Collection of essential documents and preparation essential documents packages for drug release.

Qualifications:

* A minimum of a Bachelor's degree (preferably in a Life Sciences field);
* At least 4-5 years of work experience as a Regulatory Submissions Coordinator;
* Hands-on experience preparing, reviewing, and submitting regulatory documentation;
* Full professional proficiency in French and English in written and verbal communication;
* Knowledge of Microsoft(r) Office; and
* Excellent organization and communication skills, great attention to detail.

Travel: Minimal

We kindly ask to submit applications in English. We would appreciate if you could indicate the status of your work permit if needed.
			

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