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Job Details

Senior Counsel Ii Global Therapeutic Area Legal gtal - Hiv

Experience
8 yrs required

Location
Foster City, CA, United States

Posted on
Dec 01, 2022

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Senior Counsel II, Global Therapeutic Area Legal (GTAL) - HIV
The candidate will serve as a key business partner and provide support to U.S. HIV Therapeutic Area (TA) focused functions (e.g., Marketing, Sales, Medical Affairs, Government Affairs, and Public Affairs) in delivering operational excellence in a compliant manner. Manage one or more direct reports. Provide legal and compliance advice with a focus on commercialization, promotion, marketing and advertising of the Company’s approved HIV products. Support to a wide range of Company activities such as advising on promotional review, evaluating proposed corporate business plans, strategies, tactics, grant proposals, research activities, funding requests, competitor complaints, supporting regulatory actions, investigations, working groups, and drafting and updating Company compliance policies. Provide prompt review and guidance to the HIV Promotional Review Committee (PRC) and Medical Review Committee (MRC). Develop an understanding of business objectives and how those translate into Legal’s priorities to deliver practical advice and guidance to the business. Collaborate and support as needed other internal legal functions, including Global Commercial Legal, Compliance, Litigation & Investigations, Competition, Pricing & Access, Privacy, Cybersecurity and Information Governance, and Regulatory Legal. Partner with the Global HIV Therapeutic Area Legal Team and other Therapeutic Area lawyers to enhance alignment and consistency of legal compliance guidance. Monitor legal developments affecting pharmaceutical promotion and interactions with health care professionals. Provide recommendations to reduce risk and enhance operations. Excellent written and verbal communications skills. Excellent analytical and problem-solving skills. Demonstrated experience managing direct reports. Demonstrated high EQ and client-service orientation; able to recognize and respond quickly and pragmatically to urgent situations and demanding clients. Preferred legal competencies: Knowledge of the US Anti-Kickback Statute, False Claims Act, HIPAA, Food, Drug and Cosmetic Act, and related regulatory regimes. Able to exercise judgment in working through complex issues and determine and take appropriate action where precedent may not exist. Willingness to build risk-based approaches to manage legal risk and to find pragmatic solutions. Juris Doctorate from a nationally recognized law school. Admission to practice law in one or more states. Minimum of 8 years of prior experience in a law firm, in-house, and/or government (FDA, OIG, CMS) environment advising on pharmaceutical promotion and health care fraud and abuse issues.

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