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 for Germany, Austria and Switzerland (DACH);
* Communicate with research sites in Germany, Austria and Switzerland (hospitals, etc.) to collect all essential documents required before the site starts to enroll 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 (preferably in a Life Sciences field);
* Interest in drug development and clinical trials;
* Full professional proficiency in German and English in written and verbal communication;
* Knowledge of Microsoft(r) Office; and
* Excellent organization and communication skills, great attention to detail.
*  

Travel: None

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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