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Years of Experience
ProfileLegal Counsel - Commercial Transactions The candidate will provide legal support primarily to firm’ Image Guided Therapy Device (IGT-D) business in the US and will need to be able to work with and collaborate with Philips colleagues (lawyers and non-lawyers) outside of the US. Will be part of a multi-disciplinary team and provide legal support that requires an ability to work collaboratively within the Legal Function and with multiple business stakeholders. Providing practical legal counselling and commercial contracting support for the applicable businesses’ R&D, clinical research, regulatory, procurement, manufacturing, logistics, marketing (including review of promotional materials), sales, and service activities. Coordinating and facilitating other related business initiatives when applicable. Developing and delivering internal training materials to internal clients with respect to compliance and legal matters related to all of the above as well as on Philips policies and procedures. Applying health care Compliance laws (i.e. among others Medicare Fraud and Abuse, Discount and Personal Services Safe Harbors, and Sunshine Law) and advising on marketing and sales programs from a compliance perspective.
Qualification and Experience
The candidate must have JD degree from an accredited U.S. law school and admission to a State Bar. Should have 6+ years in-house or law firm health care law experience Following substantive experience and skill set is needed: Providing successful legal commercial/transactional support for the development, purchase and sale of medical devices and services; software maintenance and support; clinical research trials - both sponsored and investigator initiated studies; procurement and other consulting services; Applying FDA regulatory guidance as part of a cross functional team to commercial and clinical research activities; Identifying business and legal risks and offering creative solutions and counseling based on a reasonable balance of the applicable issues and risks; Providing clear ethical guidance in all aspects of work; Counseling on the proper use of health care and other personal data for R&D, marketing, and other commercial uses, under HIPAA and other applicable law; Managing product liability litigation matters with outside counsel; Advising on marketing claims development and “marcom” material in the medical device space. Prior experience negotiating clinical trial agreements with hospitals and research institutions is required. Experience interacting and contracting with hospitals and health systems and/or experience with class III or class III drug/device combo devices is preferred. Experience in the image guided therapies space is desired. Familiarity with the issues surrounding cloud based solutions, software as a solution and ecosystems that support health care related IT platforms would be a plus.