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Senior Director, Commercial Corporate Counsel
Refer job# KLJI171296
Senior Director, Commercial Corporate Counsel The candidate will proactively identify and analyze legal risks related to Azurity products based on applicable laws and regulations (e.g. Anti-kickback, False Claims Act). Serve as legal advisor and business partner to commercial, medical affairs, market access and patient services teams for late stage and marketed products. Serve as lead lawyer on cross-functional product review committees. Provide high quality legal advice and counsel on advertising and promotional messaging, materials, and activities; speaker program materials and training; the dissemination of scientific communications; non-promotional disease awareness materials; patient assistance materials, programs and resources; payor marketing materials; and advisory board materials. Advise business colleagues on interactions with key customer stakeholders, including patients, physicians, payors, and specialty pharmacies. Review business materials (including brand plans, medical plans, and training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant and appropriate strategies, plans and tactics. Draft and negotiate a range of agreements, including wholesaler, GPO, product purchase, discount and rebate, data purchase, and patient hub services. Work collaboratively with Compliance to advise internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance; keep abreast of current enforcement trends and educate clients and partners accordingly. Become a trusted, go-to legal advisor that advances the company's overall mission and goals while identifying and mitigating legal risks and the company's reputation. Lead assigned legal initiatives.

The candidate should have a JD., be licensed to practice law in the U.S.; and have active membership and be in good standing in a State Bar. Should have 5-7 years of post-JD experience, preferably including both law firm and in-house in the pharmaceutical industry. MLR (medical legal review) involvement/experience is very important. Experience advising on statutes, regulations and laws relevant to the commercialization of pharmaceutical products, including the False Claims Act; FDCA, FDA promotion and labeling; federal and state anti-kickback statutes; OIG guidance documents and advisory opinions; U.S. transparency laws; anti-bribery laws, and other laws and regulations related to the commercialization of pharmaceutical products. Excellent oral and written skills. Self-motivated, strong leadership, work well independently on projects, meet aggressive deadlines, handle multiple projects, has technical knowledge, business acumen, and excellent communication skills. Sound conflict resolution skills and ability to work in a collaborative, global environment.

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