Health Care Compliance Senior Manager, Medical Devices
Location:
Somerville , New Jersey
Posted:
January 12, 2017
Reference:
3400161209/5-en-us

Johnson & Johnson, Health Care Compliance & Privacy (HCCP) is currently recruiting for a HCCP Senior Manager to support the One MD Organization.

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 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. 

With $70 billion in 2015 sales, 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 and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world. 

Under the direction of the Health Care Compliance Officer, One MD Professional Relations & Operations (PR&O) and DePuy Synthes Global Franchise Marketing, the HCC Senior Manager, will serve as the primary HCC point of contact for specific business leaders and functions within the One MD Innovation & Franchise organizations of the J&J Medical Device Group, North America, to ensure their business activities comply with HCC laws, regulations and industry standards, and company policies related to: the selling, promotion and marketing of health care products and services; interactions with health care professionals and/or government officials. 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 anticorruption laws, compliance with any government settlements, as applicable.

The HCC&P Senior Manager – Medical Devices will:
• The Sr. Manager is responsible for the review of the DePuy Synthes Franchise Marketing strategies such as the professional and consumer  marketing materials and the  marketing brand business plans from concept to implementation to facilitate compliant growth and ensure that materials comply with company policies and procedures including the Healthcare Regulatory Guidance Documents for Promotional & Marketing Practices, HCC policies, industry standards and applicable state and federal laws.
• Represent HCC on the DePuy Synthes and Ethicon Educational Grants & Donations committees; review and provide guidance on HCC requirements for the educational grant and charitable donation requests submitted for approval.
• Provide oversight, policy requirements, and recommendations on the appropriate HCP engagement process for fee for service activities in the One MD organization including the review and approval of activities, training on the process for business partners, and partnering with the PR&O organization on the tools and tracking mechanisms.
• Ensure accountability for compliance through risk assessment, problem identification, oversight & monitoring, investigation and follow ups. In consultation with the Health Care Compliance Officer/Director, Human Resources, and the Law Department, responsible for ensuring there is a mechanism in place for appropriately disciplining instances of noncompliance and ensuring consistency in the application of disciplinary action.  Provide clarity around the ambiguities of the evolving HCC environment. 
• Lead, or provide assistance to those who lead, investigations into alleged noncompliance with the company’s HCC policies and procedures.
• Provide guidance, policy interpretations and recommendations relating to the proper promotion of One MD products, as well as HCC oversight for day to day business activities.


Qualifications
• A minimum of a Bachelor’s Degree is required; an advanced degree is preferred. Current status as a Certified Compliance & Ethics Professional (CCEP®) or Certification in Healthcare Compliance (CHC®) is preferred.
• A minimum of 8 years of business experience within the medical device, pharmaceutical industry, or health care industry are required.
• At least five years in health care compliance, government contracts compliance or a related area, such as, finance or commercial contracting is required.  Experience working as an HCC or GCC Officer or Manager is preferred.
• Experience working in a matrix environment is required.
• Experience developing and implementing one or more elements of a compliance program is preferred.
• Experience with project management is preferred.
• 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 is required.
• Knowledge of commercial sales and marketing practices for healthcare products and services and the compliance risks preferred
• Must demonstrate a high level of accountability, leadership, and decisiveness and the ability to prioritize and execute on multiple and frequently changing priorities 
• Ability to support rapidly changing business models across multiple companies and sectors is required
• Strong cross company/sector collaboration and change management acumen is required
• Must have the ability to comprehend and interpret legal documents, take complex business situations and develop solutions that ensure compliance
• Exceptional written and verbal communications skills
• This position will be located in Raynham, MA, West Chester, PA, Somerville, NJ, Cincinnati, OH, or Warsaw, IN, and requires up to 25% travel within the US.


Primary Location
United States-Pennsylvania-West Chester
Other Locations
North America-United States-Massachusetts-Raynham, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-New Jersey-Somerville
Organization
Johnson & Johnson Services Inc. (6090)
Job Function
Health Care Compliance

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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