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 diagnostics, image-guided therapy, in-vivo diagnostics and cancer care (the later via recently acquired Varian). Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ abilities to provide high-quality, efficient care to patients. In fiscal 2020, which ended prior to acquisition of Varian, Siemens Healthineers had approximately 52,000 employees worldwide and generated revenue of €14.5 billion (with Varian, the revenue would have been €14.5 billion and worldwide employees would have been ~66,000).
More than 70% of critical clinical decisions are influenced by the types of technologies we provide. The Siemens Healthineers Laboratory Diagnostics (LD) business area 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 increasingly enhanced by digital applications that enable labs with advanced business intelligence, increased insight into operations, capability to standardize and optimize performance.
Within LD, the Siemens Healthcare Laboratory LLC (SHL), based in Berkeley, California, is an expert, clinical lab that is Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited since 1994. SHL is leading the way in innovative, high-complexity testing solutions to advance precision medicine and is uniquely positioned to testing and assay development services to pharmaceutical companies and clinical lab testing services to laboratory customers. SHL also has considerable experience innovating laboratory developed tests (LDTs) and has been a trusted provider of accurate, reliable reference and back-up testing services for Siemens Healthineers U.S. laboratory customers for over two decades, as well as a go-to partner for novel clinical trial testing and other testing services to pharma customers.
The Counsel (Molecular and Clinical Laboratory Services) will have primary responsibility for counseling the SHL and supporting the management teams of both LD’s Center for Innovative Diagnostics and the Molecular Franchise within LD. The Counsel will be responsible for quickly gaining a solid understanding of the various elements of the respective businesses, their goals and strategies, and for counseling business partners with respect to a wide variety of general commercial, regulatory (including CLIA), corporate, transactional, operational and governance matters. In doing so, the Counsel will, among other things, negotiate and draft complex research collaboration agreements, commercial agreements and development agreements concerning the development and sale of highly-complex medical devices and related reagents, as well as the provision of assay development and laboratory testing services.
Essential Job Functions
· Draft, review, and negotiate a wide variety of commercial or strategic agreements to meet business and legal requirements, including master services, research/validation collaborations, development & commercialization agreements, responses to complex development proposals, third-party grant funding opportunities, in addition to procurement, OEM, supply, sales, and distribution agreements.
· Collaborate with sales, R&D, quality, marketing, finance, project management, intellectual property, strategic procurement, regulatory affairs, supply chain management, service and other departments or functions to analyze and further commercial, regulatory and legal imperatives.
· As a member of their leadership teams, actively counsel the various business units and SHL, on legal matters, including diligently counseling business partners on healthcare regulations, CLIA matters, 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/coordinate training of personnel on various collaborations, commercial law, privacy, regulatory matters and other relevant topics.
· Educate business partners with regard to key commercial, competition, data privacy and significant CLIA and other 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, including SHL, as well as the broader Siemens global group.
· Serve as Secretary of SHL (LLC).
· Perform any other duties and special projects assigned by the General Counsel, Diagnostics.
· 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, including CLIA.
· Fluency with the regulatory environments, including FDA & CMS regulations, CLIA, anti-kickback laws, fraud and abuse statutes, and privacy laws applicable to medical device manufacturers.
· Fluency with key elements of procurement, manufacturing, 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, international.
· Minimum of 10 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.
· Experience counseling a highly-complex CLIA laboratory strongly preferred.
· U.S. law degree (J.D.) required.
· Admitted to practice law in either California or New York (or international law degree equivalent) (if not admitted in California or New York, obtaining an appropriate In-House Counsel license as soon as practical will be required).
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers
If you wish to find out more about Siemens Healthineers before applying, please visit: https://usa.healthcare.siemens.com/about
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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