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Senior Counsel - Regulatory Law (Medical Devices and Pharmaceuticals)
Refer job# AESP135793
Senior Counsel - Regulatory Law (Medical Devices and Pharmaceuticals) The candidate will be reporting to the Vice President/Associate General Counsel for Regulatory Law, and working with other senior attorneys dedicated to individual global businesses. Responsibility for providing legal guidance and counseling to business and functional teams (such as sales and marketing, regulatory affairs, medical affairs, finance and others). Providing advice autonomously to management personnel. Being knowledgeable about various business strategies and legal issues related thereto and proactively identifying and solving business issues with respect to science and technology matters. Independently identifying and driving development of discrete legal strategies for business units/functions with respect to healthcare regulatory matters. Leading working teams autonomously and driving working teams to resolution/decisions in a timely and thoughtful manner. Acting as an informal advisor to other members of the business units/functions and Law Department, and working collaboratively with same. Leading and participating in project teams addressing highly complex issues and matters of diverse scope.

The candidate should have JD degree or international equivalent from a nationally or internationally recognized institution. Must have 10+ years of relevant professional experience in a high-caliber law firm or comparable corporate environment. Experience in the pharmaceutical or device industry, and/or similar healthcare regulatory experience essential. Working knowledge in one or more of the following areas: Anti-Kickback Statute and False Claims Act, government price reporting (e.g., Medicaid drug rebate and 340B programs), FDA promotional and other regulatory requirements, and other laws and industry codes governing interactions with healthcare professionals.

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