Description:

Position Summary:
The Counsel will support a very wide-range of legal topics, including strategic procurement, supply chain management, as well as strategic transactions and the global operational businesses within the Diagnostics segment of A Leading Medtech Company, reporting directly to the Head of Legal, Operations, Diagnostics (who also serves as General Counsel, Point of Care).

The Counsel will be responsible for quickly gaining a solid understanding of A Leading Medtech Company' (particularly Diagnostics') businesses, portfolios, global regulatory environments, challenges, and for counseling business partners with respect to a wide variety of operational, procurement, supply, manufacturing, logistics, 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, strategic partnering agreements and joint development agreements concerning the development and sale of highly-complex medical devices, including 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, tax, intellectual property, privacy/cybersecurity and other departments to analyze and further business, regulatory and legal imperatives.
Actively counsel Diagnostics' three global business lines, including senior management, on legal matters, including diligently counseling business partners on healthcare regulations, antikickback, fraud & abuse, privacy (including data privacy), digitalization, and other topics.
Partner with R&D, Marketing and other key teams to understand the product portfolio, engineering, design, and operational implications of new products, services and initiatives.
Educate business partners with regard to key commercial, competition, data privacy and significant regulatory considerations.
Proactively develop creative and compliant solutions to assist in structuring and resolving complicated business challenges. Provide ongoing counseling regarding (and efficient implementation of) various corporate policies, initiatives and/or programs.
Negotiate with key partners, suppliers, vendors, and (when appropriate) government agencies.
Draft and review terms and conditions, terms of use, FAQs, etc. relating to the design, sale and operation of our software and or other services.
Provide thought leadership and counseling on emerging issues including responsible uses of data and AI technology.
Prepare and conduct training of personnel on various procurement, logistics, collaborations, competition, commercial law regulatory matters and other relevant topics.
Cooperate across corporate business units and departments and throughout a large group of affiliated companies to achieve optimal results while appropriately mitigating risk.
Perform any other duties and special projects as may be assigned. Critical Competencies
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.
Solid knowledge of and/or capability to quickly build expertise in healthcare legal and regulatory environments.
Working knowledge of the regulatory environments, including U.S. FDA regulations, anti-kickback laws, fraud and abuse statutes, software licensing and privacy laws applicable to medical device manufacturers.
Familiarity with key elements of procurement, manufacturing, logistics, licensing and digitalization topics, 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 legal issues and risk 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.

Education/Qualifications:

U.S. law degree (J.D.) or U.S. LLM from respected institution after a professional degree in law.
Minimum of 6 years of commercial and corporate law experience (preferably with at least 3 years of experience with a well-regarded law firm); in-house experience with a respected healthcare company or within a related highly regulated industry will also be viewed as a positively distinguishing attribute.
Admitted to practice law in the State of New York (or international law degree equivalent). If not admitted in New York, promptly obtaining a NY In-House Counsel license is required