Regulatory Submissions (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 6,000 people across 40+ countries.

Responsibilities:

* Prepare, review, and file clinical trial applications to domestic regulatory agencies;
* Prepare and submit responses to queries and amendments to clinical trial applications;
* Ensure submissions comply with applicable regulations and guidance documents;
* Advise sponsors and internal stakeholders on changing regulations and compliance requirements; 
* Track submissions and ensure timely filing of documents.

Qualifications:

* Minimum Bachelor's degree in life sciences;
* At least one year of work experience as a Regulatory Submissions Coordinator for European regulation (CTR);
* Excellent organization and communication skills;
* Knowledge of Microsoft(r) Office; 
* Hands-on experience preparing, reviewing, and submitting regulatory documentation; and
* Greek (mother tongue) and very good knowledge of English.
			

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