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In-House
Attorney
Health Care
6-8 yrs required
Senior Director, Healthcare Attorney The candidate will be responsible for providing food and drug law-related legal support to the company. The position reports to the Vice President, Legal. Provide legal support to Regulatory Department relating to regulatory legal issues including FDA correspondences and meetings, labeling negotiations and NDA/BLA submissions. Review all product-related communications including press releases, MSL materials, advertising, copy and promotional materials, and training materials. Serve as the legal representative on promotional review committee and healthcare compliance committee.Provide enforcement updates to management relevant industry litigation, settlements, enforcement actions and corporate integrity agreements. Provide legal support to the Medical Affairs and Commercial Departments related to HCP interactions and MSL/Sales Rep trainings. Provide legal support to Compliance relating to policies, trainings, corrective actions and applicable federal/state transparency reporting. Must have JD degree from a nationally recognized law school with strong academic credentials. Should be admitted to practice in California. Must have 6-8 years of legal experience with a healthcare-related law firm, regulatory agency, or a life sciences or pharmaceutical company.
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