Healthcare Compliance Lead

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.

The Healthcare Compliance Lead plays a critical leadership role in supporting CareDx’s healthcare compliance program. This role is responsible for ensuring management and execution of the company’s training and audit and monitoring plan.

Key Responsibilities:

Training & Education

• Manage comprehensive compliance training programs for employees at all levels.
• Develop engaging training materials tailored to various roles and risk areas.
• Conduct live and virtual training sessions, workshops, and refreshers.
• Monitor training completion rates and effectiveness and report metrics to leadership.
• Stay current on regulatory changes.

Audit & Monitoring

• Execute risk-based audit and monitoring plans to assess compliance with policies, procedures, and regulations.
• Conduct internal audits and reviews of operational processes, documentation, and systems.
• Identify gaps, trends, and areas for improvement; recommend corrective actions.
• Collaborate with business units to implement and track remediation efforts.

Qualifications:

• Bachelor’s degree required.
• Minimum of 5 years of experience in a healthcare compliance role, within the pharmaceutical, biotech, diagnostics, or medical device industry.
• Strong working knowledge of U.S. healthcare laws and regulations, including but not limited to: Anti-Kickback Statute (AKS), False Claims Act (FCA), Stark, HIPAA, and FDA.
• Exceptional communication, analytical, and project management skills.
• Demonstrated integrity, judgment, and ability to handle sensitive and confidential matters with discretion.

Additional Details: 

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients. 

Our competitive Total Rewards package for US Employees includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits, including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• Pre-tax commuter benefits
• And more!
• Please refer to our page to view detailed benefits at https://caredx.com/company/careers

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.

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