Associate General Counsel – Regulatory Affairs and Compliance

Job description

Discover Vanderbilt University Medical Center : Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research. Organization: OLA (Legal Affairs) 10 Job Summary: The Vanderbilt Health Executive Search Team is conducting a national search for a Division Counsel – Healthcare Innovation and Regulation. The Division Counsel – Healthcare Innovation and Regulation, provides a broad range of legal support to Vanderbilt Health’s operations, providing primary legal support for NashBio, The Brock Family Center for Applied Innovation, as well as research regulatory compliance and other regulatory matters such as fraud and abuse, Stark and the anti-kickback statute, in addition to transaction support and such other matters as may be requested from time to time by the Managing Counsel or General Counsel. This role is responsible for collaborating with Vanderbilt Health departments and divisions, delivering timely legal guidance, reviewing and negotiating a wide variety of agreements, advising on compliance matters that impact Vanderbilt Health and for collaborating as an active and engaged team member in support of the Office of Legal Affairs and its members. It is anticipated that this position will collaborate with other counsel across the Department, particularly with respect to matters involving intellectual property, and will effectively and efficiently use and manage outside counsel as needed. In addition, developing a thorough understanding of the relationships between Vanderbilt University and Vanderbilt University Medical Center will be required. The successful candidate will be a strategic thinker, an approachable adviser, and a collaborative relationship-builder who thrives in an intellectually challenging environment and demonstrates alignment with VUMC’s values. . Shift: First Shift; Remote General Responsibilities: Legal & Compliance Advisory Provide legal analysis and counsel on state and federal and compliance rules and regulations, including without limitation, fraud and abuse laws, the Stark Law, the anti-kickback statute, healthcare reporting programs (e.g, quality metrics reporting), and conflict of interest disclosure processes for employed and community physicians. Advise on and support compliance investigations, including matters related to lapse of licensure, scope of practice misalignment and other regulatory concerns. Monitor and interpret evolving federal and state regulatory requirements, including statutes, regulations and agency guidance impacting quality reporting obligations. Provide support for research compliance issues and investigations. Contracting & Transactions Draft, review, analyze, and negotiate a broad range of agreements, including professional service agreements, intellectual property agreements, research innovation and collaboration agreements, data sharing agreements, and a wide variety of transaction related documents. Support contract drafting, review, and diligence review on various transactions for Vanderbilt Health and its subsidiary organizations. Collaborate with Vanderbilt University’s Office of the General Counsel and the Center for Technology Transfer and Commercialization. Other Participate as requested in support of Office of Legal Affairs initiatives. Participate in the on-call rotation for night and weekend OLA call coverage. Such other matters as requested, recognizing that this position is anticipated to be involved in a number of unique issues and transactions for Vanderbilt Health. Qualifications: JD degree from an ABA accredited law school. Employment contingent upon State of Tennessee licensure or registration and receipt of In-House Counsel Practice Certificate. The successful candidate must also apply for and become licensed in the State of Tennessee within 12 months of employment or, if earlier, the date required under applicable rules of the Tennessee Supreme Court. Preferred Qualifications: Fifteen (15) or more years of progressively responsible legal experience related to clinical research compliance or supporting complex healthcare/life sciences clients. Experience within an academic medical center or large health system preferred. Demonstrated ability to advise leadership on sophisticated, time‑sensitive healthcare matters. Strong ability to identify, assess, and mitigate legal risks associated with healthcare matters. Exceptional interpersonal and communication skills, including negotiation and ability to educate non‑legal stakeholders. Demonstrated ability to build trust and credibility with clinical faculty, staff, administrators, and senior leadership. Proven commitment to confidentiality, discretion, and high ethical standards. Ability to stay current with evolving laws, regulations, and enforcement trends. Experience facilitating policy review, development, and institutional adoption. Ability to effectively represent institutional interests internally and externally. #LI-JC1 Our professional administrative functions include critical supporting roles in information technology and informatics, finance, administration, legal and community affairs, human resources, communications and marketing, development, facilities, and many more. At our growing health system, we support each other and encourage excellence among all who are part of our workforce. High-achieving employees stay at Vanderbilt Health for professional growth, appreciation of benefits, and a sense of community and purpose. Core Accountabilities: * Organizational Impact: Implements strategies for a sub function with direct impact to the function results.* Problem Solving/ Complexity of work: Resolves highly complex business issues that are often unprecedented that have immediate impact on own sub-function or entity and wider implications to the organization. * Breadth of Knowledge: Applies expertise within professional/technical area and uses advanced business knowledge to develop objectives.* Team Interaction: Leads a sub-function serving the organization at large or across one or more entity(s). Core Capabilities : Supporting Colleagues: - Develops Self and Others: Acts upon constructive feedback from all levels of the organization and initiates strategies to develop talent in others. - Builds and Maintains Relationships: Leverages relationships and insight to forecast potential future needs and influence delivery of work to exceed expectations. - Communicates Effectively: Anticipates difference audience concerns, styles and finds mutually beneficial solutions across conflicting and sensitive issues. Delivering Excellent Services: - Serves Others with Compassion: Demonstrates in-depth knowledge of broad-based issues and considers the interests of others to improve satisfaction of services. - Solves Complex Problems: Critically evaluates complex information and identifies trends/risks to make recommendations to improve processes across areas. - Offers Meaningful Advice and Support: Provides ongoing feedback and development discussions to motivate and support team members to maximize performance. Ensuring High Quality: - Performs Excellent Work: Anticipates problems or obstacles which may interfere with quality standards and develops plants to ensure area's quality standards are met. - Ensures Continuous Improvement: Routinely draws upon valuable learning from others, past experiences, and new information to determine key opportunities. - Fulfills Safety and Regulatory Requirements: Develops appropriate corrective actions for unsafe environments in order to ensure operational and safety compliance. Managing Resources Effectively: - Demonstrates Accountability: Identifies potential obstacles to goal achievement and develops solutions to address those obstacles. - Stewards Organizational Resources: Creates the appropriate systems and processes to effectively manage resources. - Makes Data Driven Decisions: Applies in-depth knowledge of data to recommend and implement new approaches to improve decision making capabilities. Fostering Innovation: - Generates New Ideas: Identifies opportunities and leads development of new initiatives that create value across areas. - Applies Technology: Creates the energy and drive for self/others to identify and leverage technology in new, innovative ways to drive greater efficiencies. - Adapts to Change: Anticipates the change process and clearly communicates impact on others/own team(s), assisting them in embracing the change. Position Qualifications: Responsibilities: Certifications: Work Experience: Experience Level: Education: Master's This role offers the opportunity to make a meaningful impact within Vanderbilt Health, supported by a comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well-being and professional growth. Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.