Assoc Director, Healthcare Compliance

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 Associate Director of Healthcare Compliance will report to the Director of Healthcare Compliance and partner with CareDx's functions and teams to facilitate further development and advancement of the healthcare compliance program through continuous improvement. In this capacity, the Associate Director of Healthcare Compliance will use leadership, influence, and strategic thinking to refine the healthcare compliance program, develop and execute strategies for healthcare compliance program goals, foster continued support for CareDx's healthcare compliance program, and maintain CareDx's ethical culture.

This position will interact with and advise key business function Leadership and their staff within the company.

Responsibilities:

• Through leadership, advance, execute, and grow the healthcare compliance program.
• Partner with key business functions to provide moderate to complex ethics and compliance advice and guidance, including functional policy interpretation.
• Provide strategic guidance and input on proposed business strategies and programs, identify moderate to complex legal and regulatory issues, analyze alternatives, and work with Legal and other functions, as appropriate, to propose solutions to the business.
• Develop, implement, modify, and assist with functional monitoring plans and any corrective actions to ensure compliance with healthcare compliance policies and procedures.
• Evaluate and assess key business function activities with respect to current laws, regulations, enforcement environment, and best practices related to the development, marketing, and sale of diagnostic, lab products and digital health offerings.
• Maintain awareness of the current compliance environment, assess their impact on company operations and inform functions and business leaders as needed.
• Lead internal investigations related to potential compliance violations and recommend corrective actions.
• Oversee training programs to promote awareness and understanding of compliance policies and procedures.
• Other duties as assigned

Qualifications:

• B.S. or B.A. degree with 12 years of related experience or a JD, MBA, or advanced degree in law, healthcare, or life sciences with 7 years of related experience. CCEP certification is preferred.
• Healthcare compliance experience in the Diagnostics, Biopharmaceutical or Medical Device industry, including experience with building or advancing healthcare compliance programs and working with business teams to achieve business objectives.
• Extensive knowledge of federal and state laws and industry requirements affecting the biotech/pharma/device laws and experience implementing legislative changes into the program components.
• Sophisticated ability to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations.
• Demonstrated ability to work efficiently and independently, prioritize workflow, meet demanding deadlines, and manage multi-faceted projects in a fast-moving environment
• Able to influence and gain consensus across teams.
• Ability to lead as well as collaborate, and function well in a fast-paced team environment.
• Excellent interpersonal skills and the ability to build and maintain positive work relationships and effectively interface across the organization.
• Excellent communicator - both verbal and written - with business acumen and the ability to consistently meet or exceed project deadlines.
• Flexible, high level of integrity, action and goal-oriented.

Remote: US only roles

The anticipated base salary range in the United States is $150,000 to $180,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.

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 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://caredxbenefits.com/
  

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.

By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx.

******** We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.

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