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Senior Manager, Healthcare Compliance Officer (HCCO)

Johnson & Johnson

Cutting-edge science, digital technology, and new ways of thinking are improving how people are cared for around the world, and Johnson & Johnson is at the forefront.

Johnson & Johnson is recruiting for a Health Care Compliance Officer (HCCO) Senior Manager. The position will be based at one of the following: Raritan, NJ, New Brunswick NJ, Cincinnati, OH, West Chester, PA, Warsaw IN, Raynham, MA. The position may require up to 25% travel (domestic and international).

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science — bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Johnson & Johnson is the world’s most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.

Under the direction of the Director, Health Care Compliance Medical Device ETHICON, ETHICON GSM, GES, SCG, HEMA and Strategic Insights & Pricing, the HCC Senior Manager, will serve as the primary HCC point of contact for specific business leaders and functions within the US Medical Device/MedTech group. Particular focus may include though not be limited to Global Education Solutions (GES), Account Management and US Commercial operations to ensure their business activities comply with HCC related laws, regulations and industry standards, and company policies related to: the training, education of Health Care Professionals, selling, promotion and marketing of health care products and services; interactions with health care professionals and/or government officials both US and OUS. Relevant laws and regulations include, as applicable, US federal and state anti-kickback and false claims statutes, transactional and compliance reporting, Federal Food, Drug & Cosmetic Act promotional requirements, Foreign Corrupt Practices Act and other anti-corruption laws, compliance with any government settlements, as applicable.

Responsibilities:

Under the leadership of the HCC Director, Medical Device GES, responsibilities may include:

  • Primary HCC point of contact for specific business leaders and functions within US Medical Device/MedTech in support of DePuy-Synthes and/or ETHICON to ensure business activities comply with, applicable laws, regulations and industry standards, and company policies related areas that may include though are not limited to:
    • Product Education
    • Product Training
    • Company Provided Items & Services
    • Meetings & Convention Support/Participation
    • Grants & Donations Support
    • Copy Review/Copy Clearance
    • Commercial Contracting
    • HCP Contracting Process
    • Company Provided Items & Services
  • Providing guidance, policy interpretations and recommendations, as well as HCC oversight for day-to-day business activities
  • Coordinating the HCC guidance and partnering with HCC Medical Device Group peers, the Law Department, Government Contract Compliance (GCC), and Privacy Compliance
  • Maintaining an effective compliance program for specific Medical Device/MedTech functions and organizations, integrated and harmonized with the compliance program for the J&J Medical Device Group, with particular focus on:
    • Minimizing risk by designing and embedding compliance controls into business and finance processes and ensuring that corrective actions are implemented as appropriate
    • Ensuring the implementation of these controls and corrective actions through monitoring and other oversight activities
  • Partnering with Business leadership and in collaboration with other commercial HCCOs and Government Contracts Compliance Officers, to ensure that the HCC program effectively prevents and/or detects potential violations of law, regulations and policies by:
    • Engaging Business leadership ensuring governance and oversight of the HCC compliance program
    • Acting as a consultant, reviewer and approver (e.g. copy review, as needed), for business activities from concept to implementation; providing guidance on unique offerings of products, services and solutions being developed by the business
    • Identifying potential HCC, GCC and Privacy risks associated with commercial activities and ensuring involvement of appropriate individuals within HCC, Privacy, GCC and the Law Department to provide business with appropriate guidance
  • Partnering with the HCCOs, as appropriate
  • Leading, or providing assistance to those who lead, investigations into alleged non-compliance with the company’s HCC policies and procedures
  • Supporting compliance with cross-selling and any applicable external obligations through collaboration with relevant HCC teams and functions
  • Conducting training and communication, periodic risk assessment, mitigation activities, corrective and preventive action, and reporting to relevant leaders regarding trends and recommended actions

Qualifications

• University/Bachelor’s Degree or Equivalent

• Minimum 8 years of business experience in medical device, pharmaceutical industry, or health care, with at least five years in health care compliance, government contracts compliance, legal, quality or a related area, such as, finance or commercial contracting; required

• Experience developing and implementing one or more elements of a compliance program; preferred

• Experience working as an HCC or GCC Officer or other HCC related function; preferred

• Experience working in a matrix environment; required

• Knowledge of: (1) anti-kickback and false claims laws; (2) transactional and compliance reporting laws and regulations; and (3) Federal Food, Drug & Cosmetic Act promotional requirements; required

• Experience with project management in a matrixed business organization is preferred

• Knowledge of commercial sales and marketing practices for healthcare products and services and the compliance risks preferred

Skills and abilities:

• Ability to support rapidly changing business models across multiple companies (US and OUS) and sectors

• Strong cross company/sector collaboration and change management

• Ability to advise on complex professional education training and education models and arrangements, while working towards solutions to streamline process and drive compliant growth

• Requires strong written and verbal communication skills, organizational skills, and analytical skills

• Broad business experience and a proven ability to influence business decisions and business partners

• Proven track record in delivering results, self-starter and ability to manage complexity

• Deals well with ambiguity and new areas

• Demonstrates strong organizational, process and interpersonal skills

Required Leadership Competencies

• Live Our Credo – Demonstrates and inspires the behaviors that reinforce Credo values

• Connect – Cultivates meaningful external relationships and partnerships outside of J&J, adding value and insights for the enterprise; insight-driven to proactively uncover critical unmet needs and turn them into new opportunities

• Shape – Translates insights into innovative and viable products or solutions, creating value; challenges the status quo and leads change management activities, creating positive change; takes and properly manages risks, while maintaining the highest standards of quality and compliance, contributing to value creation

• Lead – Takes ownership for talent acquisition, performance and development in a way that enhances the performance and development of self and others; maximizes and leverages diverse perspectives, backgrounds and talent to generate innovative ideas or solutions to address organizational challenges; engages in and encourages others to have transparent and constructive conversations and encourages others, contributing to a high-performing organization

• Deliver – empowers people to act with speed, agility, and accountability, enabling them to achieve organizational goals and strategies; makes decisions and takes actions based on a global and enterprise-wide mindset that adds value across the enterprise; balances short- and long-term strategic choices, positions the organization to achieve both short-term and expected future results

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (http://www.careers.jnj.com).

Primary Location
United States-Pennsylvania-West Chester-1302 Wrights Lane East
Other Locations
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-New Brunswick, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Massachusetts-Raynham
Organization
Johnson & Johnson Services Inc. (6090)
Job Function
Legal
Requisition ID
2206046829W

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Senior Manager, Healthcare Compliance Officer (HCCO)

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Johnson & Johnson

Cutting-edge science, digital technology, and new ways of thinking are improving how people are cared for around the world, and Johnson & Johnson is at the forefront.

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