Manager, Health Care Compliance
- Santa Clara, CA
- $100,000-173,500 per year
- Permanent
- Full-time
- Partner with business and functional stakeholders and provide compliance oversight and strategic guidance ensuring adherence to healthcare compliance and corporate integrity principles, for example:
- Reinforce compliance principles and embrace ownership to make compliant decisions
- Advise internal stakeholders of potential compliance risk area and develop and manage risk mitigation plans
- Act as a consultant, reviewer and approver for business activities that involve HCC risks
- Facilitate implementation of HCC policies and procedures
- Provide appropriate guidance and regular communications on HCC topics to all relevant employees
- Design and implement HCC training focused on commercial activities to enhance employee awareness and compliance with requirements
- Conduct or facilitate testing and monitoring; supporting corrective actions to close gaps identified during audits, assessments, testing and monitoring
- Facilitate maintaining an effective compliance program for the Shockwave business unit, integrated and harmonized with the compliance program for the J&J MedTech family of companies, with particular focus on:
- Minimizing risk by designing and embedding compliance controls into business processes and ensuing that corrective actions are implemented as appropriate
- Conducting or facilitating testing and monitoring and other oversight activities
- Supporting corrective actions to close gaps identified during audits, assessment, testing or monitoring
- Partner with HCC peers, other HCC groups (such as HCC Global Operations, HCC Global Transparency Organization), the Law department, and Government Contract Compliance (GCC) in support of relevant business activities.
- Develop and conduct targeted compliance training to relevant employees so that they are aware of and understand the relevant laws, regulations, and company policies.
- Proactively identify potential compliance issues and risks, advising and working with business management to mitigate these risks effectively.
- Support other HCC MedTech companies, as required.
- Maintain up-to-date knowledge of evolving healthcare compliance laws and regulations, communicating pertinent changes and implications to the business.
- Bachelor's degree or equivalent.
- A minimum of 10 years of health care compliance experience working in a compliance function or in a related capacity.
- Knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements.
- Proven ability to work collaboratively, maintain relationships and partnerships with peers and business partners.
- Strong analytical skills with the ability to communicate complex information effectively to all levels of the company.
- Strong written and verbal communication skills, organizational skills, program management skills, and analytical/process skills.
- Ability to work through ambiguity, manage complexity and deliver results.
- Self-directed, detail-oriented, motivated; demonstrates a high level of accountability, leadership, and decisiveness.
- Knowledge of commercial sales, marketing, medical education and medical affairs practices for the development and commercialization of healthcare products.
- Experience working in a matrix environment and delivering solutions that drive compliant growth.
- CCEP accreditation or similar compliance certification.