SUMMARY:

Support Health Care Compliance (HCC) director to implement and oversee the HCC program to ensure business practices and activities comply 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 Innovative Medicine China (Group Leaders) and serves as a strategic business partner and coach towards all covered employees to ensure that the company culture of compliance is a natural element in day-to-day business.

This position reports to the HCC Director, Innovative Medicine China, and should be based in Beijing, China.

PROFILE:

• Senior-level experienced compliance professional with solid compliance and people management background
• Requires strong communication, organizational, analytical and people skills, including data analytics.
• Strong project management and oversight skills are required to ensure the on-schedule implementation of the critical HCC programs.
• Broad business experience and a proven ability to influence business decisions and lead business partners to drive company-wide compliance programs.
• Capable of making strategic decisions based on the local legal, business and market environment.
• Ability to work effectively with local and regional stakeholders.
• Ability to take complex business situations and develop solutions to ensure compliant growth.
• Background may include Compliance, Legal, Finance, Medical Affairs or Regulatory
• Proven track record in delivering results, self-starter, and ability to manage complexity

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

• Partner with Innovation Medicine China Group Leaders and HCC director to ensure that the HCC program effectively prevents, detects and corrects violations of law, regulations, policies, or industry code of conduct by:
• Translate global strategies to the local level based on appropriate local needs, goals, and objectives, considering 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 of Health Care Professional (HCP)/Government Official (GO) oriented activities
• Work closely with business leadership and groups to strategically enhance compliance management and provide comprehensive HCC support in key decision-making, leading policy-making initiatives, risk assessment and remediation.
• Stimulating and contributing to innovative approaches (CSO, Channel Exploring, etc.) towards HCPs, GOs and Patients consistent with the HCC/HCBI guidelines and framework and performing business plan reviews from the HCC perspective
• Establish and optimize end-to-end process management and compliance governance for the covered business units.
• 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.
• Support the establishment of the Management Action Plan from the HCC perspective and guide the business partners in closing gaps and implementing corrective actions.
• Support audit, allegations and investigations (if any)
• Deploy policies and procedures that align and monitor activities to ensure compliance with government, private, legal and company HCC standards.
• Responsible for implementing and overseeing important HCC programs within non-Sales and MKT groups per global, regional and local requirements, covering annual risk assessment, needs assessment, ad-hoc monitoring and audit, etc.

• Additional responsibilities are as follows:
• Support the business leaders as strategic partners in HCC-related matters.
• Support and collaborate with the broader HCC community in China for cross-sector initiatives/harmonization efforts.
• Support non-Sales and MKT groups in establishing a compliance committee to detect and manage risks.

• Partnering with the Regional/Global HCC, Legal, Privacy and other relevant functions to:
• In support of the HCC Director, develop and implement business-specific policies and standard operating procedures and customize regional/global policies and procedures as well as education and training materials to reflect local requirements.
• Implement HCC training programs and periodic training on specialized subjects in coordination with the Innovative Medicine China HCC team.

Qualifications

EDUCATION and EXPERIENCE:

• Minimum of BA/BS required; MBA or any other advanced degree preferred
• Minimum of 10 years of compliance, legal or business-related experience, preferably in the pharmaceutical industry
• Knowledge of pharmaceutical business, related laws ®ulations, and industry standards for China

SKILLS and ABILITIES:

• Breadth of experience in all areas of pharmaceutical business models, compliance standards and regulation
• Independent and objective thinker, able to advance ideas and influence others.
• Manages conflicts openly and constructively.
• Demonstrate strong organizational, interpersonal and communication skills.
• Deals well with ambiguity.
• Excels at developing and maintaining effective partnerships and working relationships with key organizational stakeholders based on understanding 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 outlines the primary 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).