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Director, Healthcare Compliance, Oncology Division

Remote Opportunity

Our client, an innovative diagnostics company in Redwood City, is looking for a Director, Healthcare Compliance to join our Commercial Legal & Compliance team with a focus on supporting our Oncology Division. This new position will serve as a compliance lead responsible for enhancing the company’s Health Compliance Program to ensure compliance with all applicable legal and regulatory requirements for the promotion and sale of medical services to Oncology practices.

What we are looking for:

Experience in a healthcare organization providing legal advice on business arrangements with referral sources for designated health services (DHS). Specific prior experience in the development/deployment of compliance programs including all seven elements of the OIG recommended program for clinical laboratories.

The successful candidate will have:

  • Extensive knowledge of federal and state laws (False claims act, Starks Law, EKRA, Antikickback statute, anti-bribery and corruption) and industry requirements for the diagnostics/device laws and experience implementing suitable policies tailored for compliance with these laws
  • Solid understanding of industry best practices for ethics and compliance risk within the healthcare diagnostics industry
  • Proven track record in driving awareness and deploying risk mitigation strategies
  • Non-alarmist, pragmatic approach to risk assessment and mitigation

Responsibilities:

  • Partner with cross-functional stakeholders within the Oncology Division and collaborate with internal compliance team members to identify emerging risk areas for the Oncology Division through awareness of current product specific risk areas and industry compliance trends and challenges
  • Provide specialized legal counsel and strategic advice on a wide range of compliance issues to support the development and commercialization of Oncology test products and services
  • Developing a keen awareness of risks associated with the marketing and sale of cancer diagnostic products to proactively address issues and identify opportunities for process improvements to ensure that business programs are aligned with regulatory requirements and industry standards
  • Provide guidance with an eye towards problem solving to business partners and key stake holders through all stages of the product life cycle
  • Draft, implement and maintain relevant policies, procedures, work instructions, and training plans related to risk areas
  • Maintain current and accurate knowledge of existing and emerging trends, enforcement actions, industry best practices and laws and regulations regarding healthcare compliance and interactions with healthcare professionals
  • Advise on legal issues throughout the medical device lifecycle related to clinical research, market access and reimbursement, product launches, commercialization, advertising and promotion, social media, patient access and financial assistance programs
  • Review promotional and educational materials as part of a cross-functional team
  • Perform routine teaching audits of high-risk functional areas to assess and improve training effectiveness
  • Assist with internal investigations, as required, to promote a culture of zero tolerance for non-compliance, with heightened focus on timely follow up on incoming inquiries and complaints
  • Manage the lifecycle of corrective actions and remediation plans that address compliance related deficiencies in processes, procedures, and other operational activities
  • Assist with special projects and follow up, as needed, under the direction of the VP, Commercial Legal & Chief Compliance Officer

Requirements:

  • J.D. with 7+ years of progressively responsible experience in a legal department of a healthcare organization and/or law firm setting
  • Certification in Healthcare Fraud & Abuse Law Compliance preferred
  • Working knowledge of clinical laboratory, diagnostic, and medical device industries and designated health services and enforcement of associated federal and state regulations
  • Experience drafting, reviewing and negotiating commercial payor agreements, laboratory services agreements, phlebotomy services agreements, clinical trial agreements, professional services agreements with health care providers
  • Strong research, analytical and problem-solving skills
  • Knowledge of Medicare, Medicaid requirements, medical necessity and coding rules and guidelines preferred
  • Demonstrated ability to advise and collaborate with business leaders and key stakeholders on compliance issues, facilitating risk assessment and developing practical business solutions
  • Training and presentation experience in various settings including live audience and video conferencing
  • Excellent strategic and analytical skills with the ability to help business partners identify compliant solutions to novel issues
  • Ability to articulate risk without being an “alarmist”
  • Excellent verbal and written communication skills
  • Knowledge of privacy laws (GDPR, HIPAA, APPI and others) a plus

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