(PRWEB) June 15, 2005
SCIREX Corporation today announced the appointment of James Ottinger, R.Ph., to the position of Senior Vice President, Regulatory Affairs. In his new role Mr. Ottinger will oversee all aspects of strategy development and regulatory activities for clinical trials, and will be responsible for the strategic direction and operations of the companyÂs global regulatory affairs, corporate quality assurance, and medical writing units. As a member of SCIREXÂs executive management team, Mr. Ottinger will report to Jack Whalen, M.D., General Manager of Clinical Development Services.
Ottinger has more than 23 years of experience in regulatory affairs in positions of increasing responsibility. Most recently Ottinger was with Wyeth Pharmaceuticals where, as Assistant Vice President, Worldwide Regulatory Affairs, he was responsible for pharmaceutical product development and registration in the U.S., Europe, Canada, Asia Pacific, and Latin America. Mr. Ottinger possesses broad expertise in drug development and regulatory affairs in Japan. He has extensive experience in the therapeutic areas of neuroscience, womenÂs health, and internal medicine. He has provided regulatory counsel and strategic direction for product development programs for the treatment of depression and anxiety, AlzheimerÂs disease, schizophrenia, bipolar disorder, multiple sclerosis and neuropathic pain, and played a key role as U.S. industry advisor in the creation of the Japanese PMDA.
Ottinger received his BachelorÂs degree in Pharmacy from Saint JosephÂs University in Philadelphia, Pennsylvania, and is a graduate of the Temple University School of Pharmacy, also in Philadelphia. He holds professional memberships in the Regulatory Affairs Professionals Society, the Drug Information Association, the Pennsylvania Society of Health-System Pharmacists, and the Pharmaceutical Research and Manufacturers of America (PhRMA).
ÂIt is with great pleasure that I welcome Jim to SCIREX,Â said Jack Whalen, M.D., General Manager of Clinical Development Services at SCIREX. ÂHis expertise in pharmaceutical development and global regulatory affairs, combined with his experience-based understanding of the sponsorÂs needs and priorities, will add considerably to our ability to provide clients with high value strategic advisory and tactical operational services.Â
SCIREX Corporation is a leader in the delivery of Phase I-IV drug development services to the global pharmaceutical and biotechnology industries. SCIREXÂs clinical trial management capabilities include drug development planning, protocol design, submission services, regulatory affairs consulting, investigator and patient recruitment, data management, statistics, medical writing and offers an array of technology solutions including IVRS, EDC and SIMS(TM) (Study Information Management System). SCIREXÂs experience portfolio includes more than 1,000 clinical trials involving well over 100,000 patients, evaluating new treatments for pain and inflammation, neurological and psychiatric disorders, infectious diseases and gastrointestinal and cardiovascular indications. SCIREX is a wholly-owned subsidiary of Omnicom Group, Inc.
For more information contact Blythe Vito, SCIREX Corporate Marketing at (215) 907-1330 x1054, or visit http://www.scirex.com.