
GeneDx
9 days ago

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 Manager, Healthcare Compliance is responsible for overseeing the development, implementation, and maintenance of the healthcare compliance program at GeneDx, a commercial genomic testing laboratory. This role ensures that laboratory operations, billing practices, and regulatory reporting align with applicable healthcare laws, regulations, and accreditation standards, including CLIA, HIPAA, CMS, OIG guidelines, and state laws. This individual serves as a subject matter expert and key advisor to internal stakeholders on regulatory risk, operational compliance, and ethical business conduct.
Job Responsibilities
Program Management & Oversight
- Manage and continuously improve the laboratory’s corporate compliance program, including policies, procedures, training, and monitoring systems.
- Maintain a compliance calendar and ensure timely execution of audits, reviews, training, and regulatory filings.
Regulatory Compliance
- Ensure compliance with federal and state laws including:
- CLIA, HIPAA, CMS, Medicare/Medicaid regulations
- Anti-Kickback Statute, Stark Law, False Claims Act
- State-specific laboratory laws and reporting requirements
- Monitor updates to healthcare regulations and provide impact analysis and implementation guidance.
Training & Education
- Develop and deliver compliance training programs for laboratory, billing, sales, and support staff.
- Promote awareness of ethical conduct, patient privacy, and proper billing and marketing practices.
Auditing & Monitoring
- Conduct internal audits and investigations related to lab operations, billing, coding, referrals, and marketing activities.
- Implement corrective action plans and monitor remediation efforts.
Incident Management & Reporting
- Investigate reports of noncompliance, regulatory violations, or unethical conduct.
- Maintain compliance hotline procedures and reporting mechanisms.
- Coordinate response to compliance-related incidents, including root cause analysis and regulatory reporting when required.
Collaboration & Advising
- Serve as a compliance advisor to leadership, lab directors, and sales teams.
- Work closely with legal, billing, quality, IT, and HR to manage risk and support compliant operations.
Vendor & Third-Party Oversight
- Review and manage contractual compliance obligations (e.g., Business Associate Agreements, billing service contracts).
- Conduct due diligence on partners and vendors.
People Manager
- No
Education, Experience, and Skills
- Education: Bachelor’s degree in Healthcare Administration, Life Sciences, Law, Business, or a related field.
- Certifications (preferred):
- Certified in Healthcare Compliance (CHC)
- Certified Professional Compliance Officer (CPCO)
- Certified Professional Coder (CPC) or billing compliance credential a plus
- Experience:
- 5-7+ years in healthcare compliance, preferably within a clinical or diagnostic laboratory, hospital, or billing environment.
- Strong working knowledge of laboratory regulations and healthcare billing practices.
- Skills:
- Excellent written and verbal communication
- Strong analytical and investigative abilities
- Ability to manage multiple projects and regulatory deadlines
- High ethical standards and discretion when handling sensitive issues
Work Environment
- Full-time role; remote, hybrid or onsite to be discussed.
- Occasional travel may be required.
- The role may require occasional travel to client sites, with potential exposure to outdoor weather conditions.
- Standard work hours are Monday through Friday, 9 AM to 5 PM EST, with occasional overtime required during peak periods.
Acknowledgements
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
## LI-REMOTE
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Science - Minded, Patient - Focused.
At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.
Experts in what matters most.
With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry’s genetic testing experts and proud of it. We share the same goal as healthcare providers, patients, and families: to provide clear, accurate, and meaningful answers we all can trust.
SEQUENCING HAS THE POWER TO SOLVE DIAGNOSTIC CHALLENGES.
From sequencing to reporting and beyond, our technical and clinical experts are providing guidance every step of the way:
TECHNICAL EXPERTISE
- High-quality testing: Our laboratory is CLIA certified and CAP accredited and most of our tests are also New York State approved.
- Advanced detection: By interrogating genes for complex variants, we can identify the underlying causes of conditions that may otherwise be missed.
CLINICAL EXPERTISE
- Thorough analysis: We classify variants according to our custom adaptation of the most recent guidelines. We then leverage our rich internal database for additional interpretation evidence.
- Customized care: Our experts review all test results and write reports in a clear, concise, and personalized way. We also include information for research studies in specific clinical situations.
- Impactful discovery: Our researchers continue working to find answers even after testing is complete. Through both internal research efforts and global collaborations, we have identified and published hundreds of new disease-gene relationships and developed novel tools for genomic data analysis. These efforts ultimately deliver more diagnostic findings to individuals.
Learn more About Us here.
Our Culture
At GeneDx, we are dedicated to cultivating an environment where creativity and innovation thrive. We believe in the power of community and collaboration, where diverse perspectives are embraced, and every voice contributes to our shared success. Our team is a vibrant mix of professionals who challenge and support each other in equal measure, fostering growth both personally and professionally. When you join us, youre not just taking on a job—youre joining a movement. A movement that champions curiosity, embraces change, and believes in making an impact, one patient at a time. Cultural principles we live by:
- Be bold in our vision & brave in our execution.
- Communicate directly, with empathy.
- Do what we say were going to do.
- Be adaptable to change.
- Operate with a bias for action.
Benefits include:
- Paid Time Off (PTO)
- Health, Dental, Vision and Life insurance
- 401k Retirement Savings Plan
- Employee Discounts
- Voluntary benefits
GeneDx is an Equal Opportunity Employer.
All privacy policy information can be found here.