Leads and drives the Health Care Compliance (HCC) program 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 U.S. Foreign Corrupt Practices Act. Works closely with the commercial Business Unit (BU) leaders of Janssen China and serves as a strategic business partner and coach towards all covered employees, to assure that the company culture of compliance is a natural element in day-to-day business.
This position reports to the HCC Officer (HCCO), Janssen China, and can be based in Beijing , China.
- Senior level experienced compliance professional with strong compliance and people management background
- Requires strong communication, organizational, analytical and people skills, including data analytics
- Broad business experience and a proven ability to influence business decisions and lead business partners to drive company-wide compliance program
- Capable of making strategic decisions based on the local legal, business and market environment
- Ability to work effectively with local, regional and global stakeholders
- Ability to take complex business situations and develop solutions to ensure compliant growth is achieved
- Background may include Compliance, Legal, Finance, Medical Affairs 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.
- Partner with Janssen China BU leadership to ensure that the HCC program effectively prevents, detects and corrects violations of law, regulations, policies, or industry code of conduct by:
- Translating global strategies into local level, based on appropriate local needs, goals and objectives, taking into account local external legal, regulatory and market trends and environment
- Acting as a consultant, and where appropriate or required by the J&J International Health Care Business Integrity (HCBI) Guide, to assure review and approval for Health Care Professional (HCP)/Government Official (GO) oriented activities
- Stimulating and contributing to innovative approaches towards HCPs and GOs consistent with the HCC/HCBI guidelines and framework and performing business plan reviews from the HCC perspective
- Providing and coordinating appropriate guidance, education, training, and regular communications on HCC to all covered employees
- Conducting self-assessment and risk assessment processes to detect process gaps and inconsistencies for the covered BUs
- Ensuring that a testing & monitoring plan is in place to demonstrate that the HCC program is effective.
- Partnering with Global Audit & Assurance to deliver successful audits
- Leading the establishment of the Management Action Plan and supporting the Disciplinary Action Plan from the HCC perspective, and guiding the business partners to close gaps and implement corrective actions
- Managing day-to-day allegations and investigations
- Participating in, leading and/or supporting investigations of non-compliance and implementing the escalation process for serious allegations, as appropriate
- Providing metrics for the HCC program in Janssen China in support of Janssen China HCCO
- Additional responsibilities are as follows:
- Support the business leaders as strategic partner in HCC-related matters
- Manage, lead and develop the assigned team in China
- Support and collaborate with broader HCC community in China for cross-sector initiatives/harmonization efforts
- Partnering with the Regional/Global HCC, Legal, Privacy and other relevant functions to:
- In support of Janssen China HCCO, develop and implement business specific policies and standard operating procedures and customize regional/global 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, private, legal and company HCC standards
- Implement HCC training programs, periodic training on specialized subjects in coordination with Janssen China HCCO
- Ensure internal reporting requirements are met as per enterprise requirements and schedule
EDUCATION and EXPERIENCE:
- Minimum of BA/BS required; MBA or any other advanced degree preferred but not required
- Minimum of 8 years of compliance, legal or business-related experience preferably in the pharmaceutical industry
- Knowledge of laws, regulations and industry standards for China.
SKILLS and ABILITIES:
- 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 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 Mandarin Chinese (both written and oral) 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).