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| Associate Director NJ Open (J#27043) Associate Director, Project Physician - - [8/25/2008] Location: Titusville, NJ Posted on: 8/25/2008 Position type: Full Time Job Code: 710021 Areas of expertise desired: Other Description Johnson & Johnson Pharmaceutical Research & Development L.L.C. Johnson and Johnson Pharmaceutical Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Project Physician located in Titusville, NJ. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. The Associate Director, Project Physician will be responsible for the development and execution of clinical programs for a novel, new molecular biologic under development for the treatment of severe chronic pain. Responsible for study design, protocol development and execution of clinical studies. Acts as a liaison between company and clinical investigators. Develops credible relationships with opinion leaders, medical directors, and key regulatory officials. Responsible for medical monitoring/reporting and company safety officer activities. Evaluates adverse events (pre and post-marketing) for relationship to treatment. Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting. Acts as medical contact at company for the Food and Drug Administration and other worldwide health authorities concerning clinical/medical issues. Interprets, reports and prepares oral and written results of product research in preparation for regulatory submissions. Assists Regulatory Affairs in the development of drug/device regulatory strategies. Acts as company spokesperson regarding publication of clinical research findings and presentations to relevant FDA advisory committees. Creates clinical education and support programs. Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities. Support general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance. Participate on cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc. Reviews medical literature and related new technologies. Responsible for assessment of external clinical research proposals involving company products relevant to company's mission. More... | |||
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