************************************************************** JobCircle.com is a regional job board serving all industries and occupations in the PA, NJ, DE, NY, MD, and DC areas. We offer a regional job board, online learning, and regional job fair events for jobseekers who live in our areas of focus. To Learn More: Job Board: http://www.JobCircle.com?source=ng eLearning: http://www.JobCircle.com/courseware?source=ng Job Fairs: http://JobCircleJobFairs.com?source=ng ************************************************************** Job Title: Director, Safety & Risk Management OTC Job Location: PA: Fort Washington Pay Rate: Open Job Length: full time Start Date: 2007-12-17 Company Name: Johnson & Johnson Family of Companies Contact: Recruiter Phone: email only please Fax: email only please Description: Director, Safety & Risk Management OTC – 0710672 Please review the job description below. If you are interested in being considered, click on the button to apply to this position. You will be asked to submit your resume and to provide some career related information. You must complete all pages and view the Thank You screen in order to successfully submit your information. Apply to this position Description McNeil Consumer Healthcare Division of McNEIL-PPC, Inc., markets over-the-counter (OTC) products. The companys OTC products include complete lines of TYLENOL (acetaminophen) and MOTRIN IB (ibuprofen) products for adults and children. Other McNeil brands include IMODIUM (loperamide) A-D anti-diarrheal, ST. JOSEPH Adult Regimen Aspirin, BENADRYL and SUDAFED. Provides global evaluation of safety profile of all J&J Consumer/Over-the-Counter (OTC) products to ensure the safety of consumers utilizing our products. Assists in the development and implementation of the strategy for safety signaling processes and risk management activities. Participates in the Global Safety Review Group which includes multiple departments (Medical, Safety, Regulatory, Quality, Benefit and Risk Management, Global Product Safety, and European Qualified Safety Person) in the evaluation potential safety signals. Is considered an internal medical/safety expert to all of J&J Consumer/OTC. Medically assesses safety signaling reports. Provides medical/safety support to product defenses and regulatory inquiries on all J&J Consumer/OTC products. Participates in internal and external safety related meetings, providing medical/safety input. Serves as liaison to BRM regarding pharmacovigilance activities and maintenance of compliance to worldwide regulations. Assists in the development and implementation of strategies for Risk Management as required. Prepares medical /safety assessments for potential recalls and other market actions. Serves as medical spokesperson for media inquiries. Qualifications M.D. required. MPH or equivalent desirable. 5 to 10 years pharmaceutical industry experience; 5 years safety and/or risk management, preferably in Over-the-Counter products and/or Consumer Healthcare. Demonstrated ability or high potential to strategize, lead and execute OTC / CHC product Safety Assessments for Recalls and other Market Actions; for Critical Responses to Regulatory Authority and other inquiries; and, for Signal Detection, Pharmacovigilance and Risk Management Plans. Experience with or exposure to Adverse Event case processing and assessment, signal detection and evaluation, pharmaco-vigilance and risk management plans. Expert level skills to perform hands-on or direct safety data query and extraction processes from multiple internal and external databases, data analyses, medical / safety assessments, and medical/regulatory writing. High energy, initiative and sense of urgency to perform the duties of Safety Officer for Recalls and other Market Actions, as well as Critical Responses to Regulatory Authority and other inquiries. Well-developed ability to work on cross-functional teams, manage safety specialists and vendors. Profile Job Field Environmental Health & Safety Locations US-PA-Fort Washington Schedule Full-time Job Type Experienced Travel Yes, 10 % of the Time Company Name* McNeil Consumer Healthcare Division of McNeil-PPC, Inc. Please refer to Job code jj-664216 when responding to this ad. For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/1008414.html?source=ng to apply online. ************************************************************** For fastest processing of your resume, this employer asks that you apply to this job using the URL above. **************************************************************