Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on September 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion.
In vitro laboratory diagnostics tests account for 70% of clinical decision making. Our DX Laboratory Diagnostics (LD) business serves customers in more than 100 countries, and leads with innovative solutions in several segments of the in vitro diagnostics industry for virtually every disease and organ. These segments encompass clinical chemistry, immunoassay, hematology, hemostasis, drug testing, plasma proteins, infectious disease testing, and total laboratory automation. All of these are enhanced by digital applications that enable labs with advanced business intelligence and increased insight into operations, as well as the ability to standardize and optimize their performance.
Headquartered in Tarrytown, New York, LD has employees in the United States, Canada, Latin America, Europe, the Middle East, Asia and Australia. As Siemens Healthineers Diagnostics business help shape healthcare delivery around the world, it will continue to develop innovative technology solutions that impact patients’ lives through the continuum of care—from early detection, through diagnosis, and treatment.
The Commercial & Operations Counsel will support Strategic Procurement, Supply Chain Management and Materials & Logistics, as well as the global operational businesses of the Laboratory Diagnostics and POC business areas within the Diagnostics segment of Siemens Healthineers, reporting directly to the General Counsel POC, in her additional role as Head of Legal, Operations, Laboratory Diagnostics.
The Counsel will be responsible for quickly gaining a solid understanding of Siemens Healthineers’ (particularly LD’s and POC’s) businesses, portfolio, global regulatory environments, challenges, and for counseling business partners with respect to a wide variety of operational, procurement, supply, manufacturing, logistics, general commercial, regulatory, corporate, transactional, and other operational and governance matters. In doing so, the Counsel will, among other things, negotiate and draft complex commercial agreements, collaborations frameworks and joint development agreements concerning the development and sale of highly-complex medical devices and related reagents and consumables.
Essential Job Functions
· Draft, review, and negotiate a wide variety of commercial or strategic agreements to meet business and legal requirements, including procurement, OEM, supply, sales, distribution, research/validation collaborations, development & commercialization agreements.
· Collaborate with strategic procurement, regulatory affairs, logistics, supply chain management, sales, R&D, marketing, finance, intellectual property, and other departments to analyze and further business, regulatory and legal imperatives.
· Actively counsel the LD & POC global business areas, including senior management, on legal matters, including diligently counseling business partners on healthcare regulations, anti-kickback, fraud & abuse, privacy (including data privacy), billing third party payers (including the U.S. federal and various state governments under the Medicare and Medicaid programs), the Stark law and covered entity obligations under HIPAA/HITECH, the Sunshine Act and related topics.
· Prepare and conduct training of personnel on various procurement, logistics, collaborations, commercial law, regulatory matters and other relevant topics.
· Educate business partners with regard to key commercial, competition, data privacy and significant regulatory considerations.
· Develop creative and compliant solutions to assist in structuring and resolving complicated business challenges.
· Negotiate with key customers, partners, suppliers, vendors, and (when appropriate) government agencies.
· Provide ongoing counseling regarding (and efficient implementation of) various corporate policies, initiatives and/or programs.
· Cooperate across corporate business units and departments and throughout a large group of affiliated companies to achieve optimal results while minimizing risk.
· Proactively mitigate global and national legal risk within Siemens Healthineers and its various controlled entities and/or affiliates, as well as the broader Siemens global group.
· Perform any other duties and special projects assigned by the respective Generals Counsel to LD and POC.
· Proven ability to independently lead and execute all facets of challenging multi-disciplinary engagements with highest integrity and ethics – from preliminary/conceptual advice, through structuring, due diligence, negotiating, drafting, closing, and any subsequent conflict resolution.
· Highly polished and effective negotiation, communication, listening and drafting skills, including those suitable for interaction with senior managers and executive leadership within a global and matrixed organization.
· Expertise in healthcare legal and regulatory environment (U.S. expertise strongly preferred; in addition, CLIA experience would be favorably received).
· Fluency with the regulatory environments, including FDA regulations, anti-kickback laws, fraud and abuse statutes, and privacy laws applicable to medical device manufacturers.
· Familiarity with key elements of procurement, manufacturing, logistics, licensing, intellectual property and distribution legal issues.
· Demonstrated skill in working collaboratively with multiple teams simultaneously and coordinating with multi-jurisdictional and multi-cultural transaction partners.
· Proven ability to identify and initiate needed actions and follow-up.
· Innovation in design and delivery of legal strategies and solutions to support ever-evolving business objectives.
· Experience with monitoring and improving processes through ongoing optimization efforts, technology enhancements, and business partner feedback.
· Willingness and ability to travel domestically and, from time-to-time, internationally.
· Minimum of 7 years of corporate and commercial law experience (with at least 3 years of experience with a well-regarded law firm); distinguished in-house experience with a respected healthcare company will be viewed as a very positively distinguishing attribute.
· U.S. law degree (J.D.) required.
· Admitted to practice law in state of New York (or international law degree equivalent) (if not admitted in NY, obtaining a New York In-House Counsel license will be required).
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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