Hybrid Director, Health Care Compliance Officer

at Johnson & Johnson

• Job title: Director, Health Care Compliance Officer
• Job type: Full Time
• Experience level: Lead
• Salary: $172,000 - $297,850 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Santa Clara, United States

About the role

• Director overseeing Health Care compliance strategies in MedTech at Johnson & Johnson. Leading efforts for compliance, risk management, and operational excellence in healthcare innovations.

Responsibilities

• Providing strategic guidance and compliance support for Shockwave Medical (Circulatory Restoration); oversight and accountability for Shockwave’s integration into Johnson & Johnson compliance program; providing HCC oversight for business activities based on risk profiles;
• Partnering with colleagues to ensure compliance with HCC laws, regulations and industry standards related to the strategy and promotion of health care products and services, interactions with health care professionals (HCPs) and/or government officials (GOs) related to a number of areas including but not limited to:
• Collaborating with business partners in the development and review of commercial and medical strategies, business plans, new business models, HCP/GO engagements, and company material to facilitate compliant growth.
• Serving as a member of business leadership team(s) to represent HCC and provide input during strategy discussions and business planning.
• Providing regular updates to business leadership and collaborating with stakeholders to effectively anticipate, prevent, and detect issues and correct violations of laws, regulations, or company policies.
• Performing risk assessment, root cause analysis, risk mitigation planning and execution, and regular risk reviews to ensure compliance program effectiveness.
• Fostering a culture of accountability at all levels of the organization with a focus on credo-based decision making, integrity and operational excellence.
• Partnering with business partners and HCC colleagues to ensure governmental reporting obligations are met.
• Identifying potential compliance risks and issues associated business activities and ensuring involvement of appropriate individuals within HCC, Regulatory Affairs, Government Contracting & Compliance, Legal and other functions such as Finance and Human Resources to provide appropriate guidance, risk mitigation and assurance of mechanisms in place for identifying and appropriately disciplining instances of non-compliance and ensuring consistency in the application of disciplinary action.
• Identifying and collaborating on compliance by design activities to integrate compliance-related requirements and controls into business processes and systems.
• Working with industry associations and other external organizations, as applicable, to influence/develop industry policies and standards in close partnership with HCC Sector Lead, to shape the external environment.
• Sponsoring, leading and engaging in a variety of tasks and project initiatives to advance Health Care Compliance and/or business-related goals.

Requirements

• Bachelor’s degree is required.
• Master’s degree in related field or other advanced degree preferred.
• 10+ years of business-related experience required.
• 5+ years of experience in HCC or related compliance/risk management function (e.g., Legal, Regulatory, Quality, Finance).
• 2+ years of People Management experience with strong track record of people management with ability to lead and develop team.
• Knowledge of relevant laws, policies, standards, financial or auditing practices and company business and policies.
• Knowledge about industry associations, their modus operandi and related policies is a plus.
• Experience in the development and/or implementation of a compliance program and risk management solutions in accordance with an organization's risk profile.
• Excellent verbal and written communication skills.
• Ability to advise senior leaders and stakeholders on business initiatives or complex issues.
• Strong collaboration with demonstrated evidence of maintaining relationships and partnerships with peers and business partners and ability to influence across all levels of the business.
• Broad business experience with working knowledge of commercial sales and marketing practices and medical affairs strategies for healthcare products and services.
• Ability to analyze data and trends, and communicate complex information to all levels of the company.
• Engaging and personable demeanor; self-directed, detail-oriented and motivated; demonstrate a high level of accountability, leadership, and decisiveness, the ability to lead projects, and the ability to work through ambiguity and prioritize and execute on multiple and frequently changing priorities.
• Experience working in a matrix environment to deliver solutions which drive compliant growth.
• Experience working with the governmental regulatory bodies and managing HCC company policies preferred.
• Experience working as an HCC or GCC Officer preferred.
• Current Certified Compliance & Ethics Professional (CCEP®) and/or Certification in Healthcare Compliance (CHC®) status preferred.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year