Principal Analyst, Healthcare Compliance
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Principal Analyst, Healthcare Compliance – Circulatory Restoration
New Brunswick, Raritan NJ or Santa Clara, CA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview Principal, Healthcare Compliance (HCC) - MedTech will support Shockwave Medical (Circulatory Restoration) and will report to the Director, Healthcare Compliance Officer - MedTech. The Principal Analyst is a key member of the compliance team and is primarily responsible for the facilitation of processes designed to ensure the Company meets statutory and regulatory requirements relating to health care fraud and abuse; as well as advertising and promotion laws governing the Company's commercial and scientific activities. This position supports the alignment of the Company's HCC activities within the overall organization and reinforces the message that compliance is a Company priority and has access to the resources needed to assure implementation of an effective compliance program.
This position can be located in New Brunswick, NJ, Raritan, NJ or Santa Clara, CA. If not located in Santa Clara, CA, periodic travel to headquarters in Santa Clara, CA may be required.
Responsibilities (This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned by supervisor).
- Advise and engage with the business, providing compliance support for Shockwave Medical (Circulatory Restoration), assisting with the development, implementation, and ongoing improvement of the company's Compliance Program
- Support Shockwave's further integration into Johnson & Johnson compliance program, including policies and procedures
- Provide input into risk assessment, risk mitigation planning and execution, and regular risk reviews to ensure compliance program effectiveness
- Foster a culture of accountability at all levels of the organization with a focus on credo-based decision making, integrity and operational excellence
- Identify potential compliance risks and issues associated with business activities and ensure involvement of appropriate individuals
- Review of business activities that involve HCC considerations such as Third-Party Intermediary (TPI) due diligence and cross border interactions
- Lead the development and management of compliance data analytics and monitoring to help identify and understand potential areas of compliance vulnerability, supporting corrective action where needed
- Develop and track compliance dashboards, KPIs, and other meaningful data to measure and report on the healthcare compliance program
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utilizing J&J Enterprise HCC systems
- Manage compliance training and communication initiatives to enhance employee awareness and compliance with requirements by assisting with planning, content creation, deployment and tracking
Qualifications & Experience
- Bachelor's degree required; advanced degree is preferred
- Minimum of 8 years of business experience with a minimum of 2 years of experience in health care compliance, government contracts compliance or a related area, such as, finance or commercial contracting; or commensurate experience in application of compliance polices to business is preferred
- Working knowledge and understanding of regulations pertaining to Healthcare Compliance (AKS, False Claims, Stark, HIPAA, etc.).
- Proficient in Microsoft Office suite including but not limited to Word, Excel, PowerPoint, and other applications
- Strong ability to develop and implement tools, including dashboards, graphs, flow charts and other visual aids
- Proficient competencies with data analytics, data accuracy, and data integrity
- Strong analytical and problem-solving skills with attention to detail
- Possess excellent communication skills with the ability to write clearly and concisely and interact with a wide range of professional levels
- Comfortable working in and supporting fast-paced and fast-growing business environment
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