[Janssen] Health Care Compliance Manager



Implements the Health Care Compliance (HCC) program locally under the supervision of the Health Care Compliance Officer (HCCO), Janssen Japan, to ensure business practices and activities are in compliance with related Johnson & Johnson (J&J) internal guidelines, local laws and regulations and anti-corruption laws including the Foreign Corrupt Practices Act.  Serves as a strategic business partner for management and coach towards all covered employees, to assure that the company culture of compliance is a natural element in day to day business.

  • Reports to the Health Care Compliance Officer, Janssen Japan, and is based in Tokyo, Japan
  • Requires strong communication, organisational, analytical and people skills
  • Broad business experience and a proven ability to influence business decisions and lead business partners to drive company-wide compliance program
  • Ability to work effectively with both local, regional and global stakeholders
  • Ability to take complex business situations and develop solutions to ensure compliant growth is achieved
  • Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, or Regulatory
  • Proven track record in delivering results, self-starter and ability to manage complexity a must

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.


Under the supervision of the HCCO of Janssen Japan, the Manager is responsible for developing, supervising the implementation and execution of the HCC program relating to Janssen Japan as well as collaborating with the broader HCC team in Japan on the implementation of the cross-sector J&J compliance initiatives in Japan, risk assessment, Management Action Plans and monitoring, among others, consistent with the business needs and standards developed by J&J HCC. The Manager will be also responsible for partnering with one or more of the Business Units (BU) of Janssen Japan to provide guidance and advice from HCC perspectives to ensure compliant growth, specifically:

    • Translating global strategies into local level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment
    • Acting as a consultant, and where appropriate, or required by the J&J International Health Care Business Integrity (HCBI) Guide, assuring review and approval for Health Care Professional (HCP)/Government Official (GO) oriented activities
    • Stimulating and contributing to innovative approaches towards HCP’s and GOs consistent with the HCC/HCBI guidelines and framework and performing business plan reviews
    • Providing and coordinating appropriate guidance, education, training, and regular communications on HCC to all covered employees
    • Conducting self-assessments and risk assessments to detect process gaps and inconsistencies
    • Executing a testing & monitoring plan in place to assess that the HCC program is effective
    • Partnering with Corporate Internal Audit to deliver successful audits
    • Establishing and monitoring the progress of the Management Action Plan, and guiding the business partners to close gaps and implement corrective actions
    • Managing day-to-day allegations and investigations
    • Participating in and leading investigations of non-compliance and implementing the escalation process for serious allegations, as appropriate
  • Additional responsibilities as follows:
    • Supporting the business leaders as strategic partner in compliance matters
    • Supporting and collaborating with broader HCC community in Japan for cross-sector initiatives/harmonization efforts
  • Partnering with the relevant Global/Regional HCC groups to:
    • Develop and implement business specific policies and standard operating procedures and customize global/regional policies and procedures and education and training materials to reflect local requirements
    • Deploy policies and procedures that align and monitor company activities to ensure compliance with government, legal and company HCC standards
    • Implement HCC training programs, including new employee orientation, periodic training on specialized subjects, and annual refresher training
    • Maintain employee certification and training attendance records
    • Ensure external reporting requirements are met per local regulations
    • Ensure internal reporting requirements are met per enterprise requirements and schedule
  • Interface with legal counsel regarding HCC requirements and interpretation
  • Interface with the regional and Japan HCC community to share approaches to HCC



  • Minimum of BA/BS required; other advanced degree preferred but not required
  • Minimum of 7 to 10 years business, legal and/or compliance-related experience
  • Knowledge of laws, regulations and industry standards for Japan


  • Breadth of experience in all areas of compliance and regulation
  • Independent and objective thinker, able to advance ideas and influence others
  • Manages conflicts in an open and constructive manner
  • Demonstrate strong organizational, interpersonal and communication skills
  • Deals well with ambiguity
  • Excels at developing and maintaining effective partnerships and working relationships with key stakeholders at all levels of organization based on an understanding of their concerns, needs and motivations.
  • Ability to make and stand by difficult decisions 
  • Strong drive for results and solution orientated
  • Fluent in English (reading, writing, verbal)
  • High level of integrity with good ethical core values
  • Fluent in Japanese required

COMMENTS:  This position description is an outline of the major recurring responsibilities of the job.  It is not intended to be all-inclusive of the work to be performed.  Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent(s). 

Janssen Pharmaceutical K.K. (7195)
Requisition ID