Non-Clinical Regulatory Subject Matter Expert
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POST DATE 9/6/2016
END DATE 11/5/2016
JOB DESCRIPTIONNon-Clinical Regulatory Subject Matter Expert
Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 40 countries across the globe. We continue to steadily grow and are looking to add to our team!
Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Non-Clinical Regulatory Subject Matter Expert to join our team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
DESCRIPTION OF JOB DUTIES
* Contribute to the development plans and study design in relevant areas ;
* Act as subject matter expert to all projects with non-clinical aspects;
* Manage relationships with competent authorities through frequent interaction;
* Advise on all nonclinical sections for all types of regulatory submissions;
* Provide regulatory advice and guidance to project teams to ensure approach meets regulatory requirements; and
* Maintain up-to-date knowledge of regulatory requirements
* PhD in Toxicology, Pharmacology, or related field;
* At least 8 years of global drug development and regulatory affairs experience in the CRO, Biotechnology or Pharmaceutical industries;
* Preferred experience working with FDA CBER and CDER;
* Strong computer skills, project management skills, and a high attention to detail;
* Strong communication skills (both written and oral); and
* Must be a team player.
Travel: Less than 10%
At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.
WHAT TO EXPECT NEXT
We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.
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