Regulatory Submissions Coordinator (Study Start Up)

				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 initial clinical trial applications to regulatory authorities;
* 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 is required (preferably in a Life Sciences field);
* Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries;
* Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
* Knowledge of regulatory guidelines in the UK;
* Excellent organizational and prioritization skills;
* Use to work independently with a proactive approach;
* Knowledge of Microsoft Office;
* Great attention to detail and excellent oral and written communication skills.
			

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