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Assistant Senior Counsel / Senior Counsel - Legal Compliance Duties: Working in the Global Legal Function, will be empowered to own work and make meaningful contributions to the organization. Provide practical, timely, quality legal services to help the company meet its business objectives through deep understanding and compliance with laws, rules and regulations applicable to the company's businesses. Provide legal advice to U.S. Business Unit and other units in Takeda relating to business operations. Advise the Office of Ethics and Compliance, Marketing, Sales, Contracts & Pricing, Managed Markets, Government Affairs, Research and Development, Vaccines Business Unit, and other stakeholders regarding the laws and regulations governing the company’s interactions with customers, health care providers, clinical research organizations and sites, and state and federal programs (e.g. Medicare, Medicaid, VA). Draft U.S. compliance policies and procedures and template compliance language for commercial agreements entered into by U.S. companies. Support compliance audits and conduct internal investigations to ensure compliance with the company’s Code of Conduct and other policies. Monitor developments in federal, state, and municipal laws, regulations and industry guidance related to fraud and abuse, federal acquisition regulations, restrictions on pharmaceutical company interactions with health care providers, marketing reporting laws, and other compliance issues. Retain and direct the activities of outside counsel.
Qualification and Experience
Qualifications: JD Degree. 7 years of experience in one of the following: law firm or corporate law department; government agency; or other relevant experience. Significant law firm or corporate legal department experience advising health care companies on compliance laws. Strong understanding of laws, regulations and industry guidance related to health care compliance and government programs, including anti-kickback statutes, federal acquisition regulations, Medicare, Medicaid, and VA program regulations, CMS regulations regarding government pricing metrics, false claims statutes, the PhRMA Code, and OIG guidance and CMS regulations. PREFERRED: Experience negotiating and drafting commercial rebate agreements, and ability to make quick decisions in the context of fast-paced negotiations.
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