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Years of Experience
ProfileFDA & Healthcare Regulatory Lead Counsel
Qualification and Experience
Qualifications: Will have a U.S. law degree (JD Degree) required. Will have 15+ years of FDA regulatory legal experience in a well-regarded healthcare-recognized law firm, in FDA and/or the in-house legal department of a leading healthcare company; significant in-house experience a strong plus, especially within a publicly-listed company. Will have excellent verbal and written communication skills. Will have an ability to calmly prioritize and execute tasks and demonstrated achievement in a fast-paced, sales-focused environment. Will have admitted to practice law in Commonwealth of Pennsylvania (or ability to obtain Pennsylvania Limited In-House Corporate Counsel License). A proven ability to independently lead and execute all facets of challenging and intricate engagements and do so with highest integrity and ethics and in real-time. Are highly polished and effective within negotiation, communication, listening and drafting skills, including those suitable for interaction with senior managers and executive leadership within a global and matrixed organization and with senior management of key customers. A deep expertise in u.s. federal & state healthcare legal and regulatory environments, including advertising and promotion, product claims, manufacturing processes, quality systems, sales and distribution. Fluency with the various healthcare laws and regulations, including anti-kickback laws, fraud and abuse statutes, and privacy laws applicable to medical device manufacturers and pharmaceutical companies, as well as those applicable to their respective customers. Ability to distill and articulate such complex legal concepts into concise and plain english that business partners can both understand and readily act upon. A passion for the healthcare device industry and solid understanding of its business models & strategies. A proven skill in influencing change and building cooperation across corporate business units and departments and throughout a large group of affiliated companies to timely achieve optimized results while minimizing risk. Demonstrated skill in working collaboratively and efficiently in a complex, matrixed and fast-paced environment and with multiple teams simultaneously, some of whom may be outside of the u.s. A proven ability to identify and initiate needed actions and follow-up and to find practical solutions. Demonstrate innovation in design and delivery of legal strategies and solutions to support ever-evolving business objectives and to address emerging market expectations. Experience in monitoring and continually improving processes through ongoing optimization efforts, technology enhancements, and business partner feedback. A willingness and ability to travel domestically and, from time-to-time, internationally.
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