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 business leaders of non-Sales & Marketing groups at Janssen China (Group Leaders) 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 either Beijing or Shanghai, 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 Group Leaders 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 groups
- 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).