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Senior Counsel â€“ Commercial Operations and Medical Affairs The candidate will be responsible for advising Firmâ€™s commercial operations on a wide variety of issues concerning the sale, and promotion of biopharmaceutical products in the United States, with specific focus on biosimilars, as well as activities with the healthcare community conducted by Firmâ€™s medical affairs organization. Advising Firm commercial operations on marketing, sales and product access strategies in the biosimilar space; pricing and contracting; helping clients navigate healthcare fraud and abuse regulations, FDA promotional regulations, antitrust and anticompetitive considerations and healthcare compliance requirements. Counseling commercial leadership on industry trends, including government enforcement actions relating to the promotion of biopharmaceutical products including biosimilar agents. Providing on-going training to commercial operations staff regarding legal and regulatory requirements for commercial activity in the biopharmaceutical industry. Advising Firm medical affairs personnel on scientific exchange activities and interactions with healthcare professionals. Analyzing, reviewing and approving promotional and scientific education materials. Must have JD degree or LL.M. degree from an ABA accredited law school, admission to practice law in a U.S. jurisdiction and 4+ years of experience practicing law. Should preferably have 8+ years of government, in-house or law firm experience advising and counseling clients. 4+ years experience advising healthcare industry- related clients on complex legal and regulatory matters is preferred. 3+ years experience in supporting commercial activities in the generic or biosimilar space is desired. Understanding of sales, marketing and healthcare compliance laws and regulations outside the US is helpful.
Job ID: R-49841
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