Vice President Commercial Legal

Profile

Vice President, Commercial Legal
The candidate will be responsible for providing legal advice to global commercial organization, including Sales, Market Research, Decision Science, Field Training, Market Access and Global Marketing. Provide input into product launch planning. Advise on major brand and commercial initiatives. Advise business partners on various commercial initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation. Provide legal advice and counsel on advertising and promotion strategies and activities, including digitally-enabled promotional activities. Oversee and provide counsel concerning a broad range of global legal issues, including, among other things, application and interpretation of FDA and other global regulations, including the False Claims Act, Anti-Kickback Statute and competition law in connection with promotional and non-promotional activities, marketing strategies, sales compensation, and interactions with patients and healthcare professionals. Act as a subject matter expert on matters relating to healthcare law and related business operations, staying stay abreast of evolving healthcare legislation and regulations and the enforcement landscape strategy while addressing legal risks and protecting the company’s integrity and reputation. Should have a JD from an ABA accredited law school. Should have 15+ years post-JD experience, preferably including both in a law firm and in-house in the biopharmaceutical industry. Should have prior experience counseling global pharmaceutical companies on legal issues relating to global marketing and distribution of commercial products, including vaccines, advertising and promotion, scientific exchange, and interactions with health care professionals. Member of a state bar and eligible to practice as a member of the in-house bar in Massachusetts is needed. Outstanding ability to effectively communicate sound legal advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needs are needed. Excellent analytical and problem-solving skills are essential. Experience advising on statutes, regulations, and guidance documents applicable to commercial operations and medical affairs activities, including: research and interpretation of the Food, Drug, and Cosmetic Act; FDA regulations and guidance; federal and state anti-kickback statutes; OIG guidance document and advisory opinions; the False Claims Act; the Sunshine Act; and the PhRMA Code, is preferred. Experience serving on a promotional review committee is required. Should be self-starter and life-long learner with a strong work ethic, international experience and excellent interpersonal skills who enjoys working collaboratively and cross-functionally on teams, as well as independently. Proactively solves problems and makes decisions are needed.

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