GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com.

Summary

The Senior Counsel, Healthcare will provide strategic and practical legal guidance on complex healthcare matters affecting GeneDx, a publicly traded genetic testing company. Fueled by one of the world’s largest rare disease data sets, GeneDx’s industry-leading exome and genome tests translate complex genomic data into clinical answers that unlock personalized health plans. This position involves advising leadership cross-functionally, and particularly the commercial, laboratory operations, and medical affairs teams to promote and ensure adherence to (A) healthcare laws, regulations, and industry standards, including those related to healthcare fraud and abuse; (B) reimbursement; (C) data privacy and security, reimbursement, and licensing. The Senior Counsel will play a key role in identifying and mitigating legal and other risks, navigating regulatory challenges, and supporting the organization’s business objectives within a highly regulated healthcare environment. We seek an experienced, thoughtful and collaborative healthcare attorney who can help us identify and solve problems in a pragmatic and creative way. We also seek a senior attorney who has a sharp ability to work well and responsively in a fast-paced and nimble environment.

Job Responsibilities

• Contract Negotiation: Supporting the commercial team, advise on and negotiate a variety of revenue-generating contracts, including payer agreements and other agreements relating to GeneDx’s research and scientific collaborations. The Senior Counsel will provide strategic guidance on contract terms, risk mitigation, and compliance, while collaborating cross-functionally to align agreements with company goals.
• Healthcare Law Compliance: Provide expert legal counsel to management and business teams on a wide range of healthcare law issues, including compliance with federal, state, and local regulations (e.g., False Claims Act, CMS guidelines, and FDA regulations). Advise on compliance with healthcare fraud and abuse laws, including structuring business arrangements (e.g., physician compensation arrangements, referral agreements, and contracting structures) to comply with the Anti-Kickback Statute, Stark Law, and similar state laws.
• Promotional and Marketing Support: Responsible for legal review of promotional and marketing materials and publications.
• Privacy and Data Security: Advise on the legal and regulatory aspects of healthcare data privacy and security, including compliance with the Health Insurance Portability and Accountability Act (HIPAA) and state privacy laws. Support the organization in managing risks related to healthcare data breaches and cybersecurity issues.
• Risk Mitigation and Management: Identify, assess, and advise on potential legal risks associated with regulatory and operational activities. Develop strategies to mitigate risks and ensure compliance with evolving healthcare laws and regulations.
• Government Relations and Agency Interactions: In collaboration with the regulatory affairs, government affairs and quality teams, serve as a legal liaison with governmental agencies such as the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General (OIG), the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and other relevant regulatory bodies, as appropriate. Manage responses to audits, investigations, and regulatory inquiries.
• Legal Monitoring and Strategy: Stay abreast of regulatory and legal developments in the healthcare industry and ensure that the organization is prepared for changes in the regulatory landscape. Communicate potential risks and opportunities to senior management and other stakeholders.
• Training and Education: Develop internal training programs on healthcare law compliance, helping to ensure that key stakeholders understand and comply with healthcare regulatory requirements.
• Transactional Support: Provide support in mergers, acquisitions, joint ventures, and other strategic business transactions involving healthcare providers, payers, and biopharmaceutical companies.

Education, Experience, and Skills

• The successful candidate will hold a law degree from an accredited law school and be licensed in good standing to practice law in at least one state and one federal jurisdiction within the United States.
• At least 8-12 years of relevant healthcare law experience.
• Proven track record in advising healthcare organizations on commercial transactions and regulatory matters, managing legal risks, and providing practical, business-oriented legal advice.
• Experience in regulatory investigations, audits, and enforcement actions by federal or state agencies.
• A commercially oriented attorney with strong strategic, commercial and interpersonal skills who understands the nuances of complicated regulatory issues and is well able to think creatively to problem solve and mitigate risk while supporting business objectives.
• Proven ability to collaborate effectively within legal team and other team members
• Superior writing skills with an ability to present nuanced, complicated and content rich issues clearly and succinctly.
• Demonstrated ability to exercise independent judgment effectively.
• Ability to draft and implement key corporate policies and procedures to empower and enable associates to achieve business objectives in a compliant manner.

Physical Demands

• Primarily sedentary work with extended periods of sitting at a desk and working on a computer.
• Repetitive hand and finger movements for typing, writing, and handling office equipment.

Work Environment

• The role may require occasional travel to work sites in Gaithersburg, Stamford, or NYC, with potential exposure to outdoor weather conditions.
• Standard work hours are Monday through Friday, 9 AM to 5 PM EST, with overtime required during peak periods.