Compliance Program Manager
Compliance Program Manager
Invitae is a leading medical genetics life sciences company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. We are looking for a Compliance Program Manager to work with our Chief Compliance Officer (“CCO”) and his team to strengthen our culture of compliance and integrity, build and deliver practical process and internal controls, conduct scenario-based training, and conduct monitoring, auditing, and investigations consistent with the Office of Inspector General (OIG) Compliance Program Guidance, applicable local, state, federal and ex-US laws and regulations, company business strategy, company values and compliance expectations. We are looking for an experienced healthcare compliance leader from the laboratory and/or life sciences industry. This cross-functional champion must be resourceful and able to operate, execute and lead successfully in a highly-collaborative, team-oriented environment.
PRIMARY RESPONSIBILITIES AND ESSENTIAL DUTIES
- Partner with the CCO’s team in coordinating an effective compliance program, ensuring consistent and effective global operation of compliance training, communications, monitoring, transparency and policies;
- Develops, implements, updates and maintains policies and procedures in support of the compliance program and to mitigate designated risks (e.g., healthcare compliance, other state laws, anti-corruption, trade sanctions);
- Manages tracking and completes necessary government reporting for disclosure of gifts, payments to healthcare professionals, research, and clinical trials;
- Works closely with the legal and business teams who provide primary support for relevant business functions;
- Collaborates with key stakeholders (e.g., sales, marketing, medical affairs, clinical) to address questions and issues, and implement compliance work plans;
- Provides leadership and review capabilities for the Company Grant Review Committee and critical tracking mechanisms;
- Creates practical, understandable policies and procedures to make compliance easy, fast and efficient;
- Develops, implements, and maintains on-line compliance learning curriculum necessary for annual industry and legislative training certifications.
- Build knowledge hubs and tools to make compliance resources more accessible, and cascade compliance information on a timely basis.
- Develop and lead on-line and live training programs, set up monitoring programs as an early warning system, and implement audit programs to assess the state of compliance.
- Conduct investigations of alleged misconduct.
- Drive global consistency in our compliance program and ensure best practices are shared and adopted across geographies and functions.
- Other Duties as assigned.
MINIMUM REQUIREMENTS AND QUALIFICATIONS
- Minimum of 8 years’ experience in healthcare compliance
- Knowledge of federal healthcare fraud and abuse laws, including the Anti-kickback Statute, False Claims Act, Foreign Corrupt Practices Act, Stark Law, U.S. Federal and state transparency reporting requirements, Food Drug and Cosmetic Act, and other relevant law and regulations
- Experience in lab developed test and medical device environments
- Understanding of sales, marketing, product promotion, disease education, device regulatory compliance
- Ability to exercise judgment and propose courses of action where precedent may not exist
- In-depth understanding of business objectives and how those translate into healthcare compliance priorities to deliver advice and guidance to the business
- Excellent interpersonal, communication (written and verbal), listening, and influencing skills
- An inquisitive mind with strong analytical, critical thinking, and problem-solving skills
- Ability to work effectively in a global, matrixed organization with multiple functions, together with a positive attitude, strong work ethic, professional maturity, and personal integrity
- Independent, self-starter with a solutions and results-oriented mindset
- Experience with systems and structures that facilitate an efficient and effective compliance program, including mobile platforms
- Experience, confidence, resilience and gravitas to work with senior executives and establish rapport with key stakeholders, continually seeking voice of customer
- Adaptable to a cross-functional and fast-paced environment
- Strong organizational and project management skills