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James Ottinger, RPh
Vice President, Global Consulting and Compliance

Mr. Ottinger oversees the strategic direction and operations of the company's regulatory affairs, safety/medical management, strategic product development, and quality assurance departments. He has more than 25 years of experience in drug development in positions of increasing responsibility and scope in regulatory affairs at Wyeth Research, SCIREX and Premier Research.  He has expertise in the areas of analgesia, psychiatry, neurology, anti-inflammatory, and women's health. Mr. Ottinger has broad experience in regulatory strategy to support both Investigational New Drug Applications and New Drug Applications, and has lead global regulatory strategy for successful marketed brands such as Effexor® XR. Mr. Ottinger’s experience in drug development and regulatory affairs includes interactions with the both the regulators and major pharmaceutical companies in the U.S., Europe, and Japan.  He played a key role in PhRMA as a U.S. industry advisor in the creation of the Japanese PMDA. Mr. Ottinger received his bachelor's degree in pharmacy from Temple University School of Pharmacy in Philadelphia, and attended Saint Joseph's University for pre-pharmacy curriculum, also in Philadelphia. He holds professional memberships in the Regulatory Affairs Professionals Society, the Drug Information Association, and the Pennsylvania Society of Health-System Pharmacists.


 

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News  03-Nov-09 Premier Research’s Functional Sourcing Services Expand to Eastern Europe
News  20-Oct-09 Premier Research Names Bernard Sweeney as Executive Director, Medical Devices
News  09-Sep-09 Premier Research Strengthens their Medical Affairs and Strategic Consulting Group with New Appointments
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