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Commercial Counsel The candidate will serve as strategic business partner to the brand team. Will serve on the review committees for promotional materials and medical materials. Provide legal counsel to commercial organization, including in respect of commercial program design, implementation and compliance with Federal and state anti-kickback statutes, false claims acts, the Food, Drug and Cosmetic Act, HIPAA, product liability law. Provide legal advice on product risk management, product liability matters and strategic brand strategy and planning. Advise on promotional materials, disease awareness, field sales training, social media initiatives, patient services and assistance, speaker programs, product labeling, payer and managed markets information, product reimbursement. Medical Affairs support and advice on: Materials and interactions of Medical Science Liaisons; Clinical and Health Economic Research; Medical Information. Coordination with Commercial organization as pipeline candidates are developed and commercial launch planned. Must have 6+ years’ experience in the biopharmaceutical/life sciences department of a leading law firm and/or an in-house legal department of a multinational pharmaceutical corporation. Should have JD degree from an accredited law school. Strong technical background in the commercialization of biotechnology/pharmaceutical products is required. Experience with FDA regulations, federal anti-kickback, false claims act statutes and HIPAA is needed.
Job ID: 8500
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