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Director and Senior Corporate Counsel The candidate will be serving as the lead product attorney who advises on laws applicable to the U.S. launch of a prescription pharmaceutical product. Will be serving as a member of various cross-functional teams (including promotional and medical material review committees) for firmâ€™s products and product candidates. Reviewing and providing guidance on disease education/disease awareness campaigns and promotional marketing materials, speaker programs, press releases, grants and sponsorships, investigator sponsored studies, market planning activities, sales incentives and direction, commercial learning, medical communications, patient education materials, reprint distribution and publication plans. Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions and government entities. Providing guidance to Commercial and Medical Affairs functions (including senior managers) on appropriate interactions by, and allocations of responsibilities between, Commercial and Medical Affairs functions. Advising and training on the Food, Drug and Cosmetic Act, Federal and state Anti-Kickback Statutes, False Claims Act, HHS OIG fraud and abuse, Sunshine Act/Transparency laws, product liability, privacy, HIPAA/HITECH, industry codes (e.g., PhRMA Code, ICJME and GPP standards and ACCME guidelines), and other laws and regulations applicable to pharmaceutical commercialization. Assisting with the development, implementation and interpretation of healthcare compliance policies SOPs and programs related to healthcare compliance and FDA-regulated matters, including but not limited to interactions with healthcare professionals, speaker programs, co-pay cards, expanded access, product samples, advisory boards, market access activities, competitive intelligence and activities at scientific congresses. Reviewing and negotiate commercial agreements, including marketing, distribution and other related agreements. Provide advice with respect to government pricing and reimbursement. As part of a small, but growing, legal department, participate in various projects outside of these primary responsibilities, including contract reviews and other matters in the Legal Department. Admitted to practice law (preferably in California) is needed. Should have 7-10 years combined relevant experience in an in-house legal department of a pharmaceutical or biotech company, ideally preceded by large, national law firm experience. Extensive experience in legal, compliance and regulatory matters relating to the approval and commercialization of pharmaceutical products is needed. Comprehensive knowledge of the Anti-kickback Statute, Fraud and Abuse Laws, False Claims Act, PhRMA Code, OIG Guidelines, Food, Drug & Cosmetic Act and other applicable laws, as well as enforcement trends are needed. Knowledge of distribution, wholesaler, market access, patient access and applicable privacy laws and regulations are needed.
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