J&J Family of Companies HCC Officer, Asia Pacific Medical Sciences in Singapore, Singapore

Leads and drives the Health Care Compliance (HCC) program to ensure business practices and activities are in compliance with related J&J internal guidelines, local laws and regulations and anticorruption laws and fraud and abuse laws including the Foreign Corrupt Practices Act, and the US Janssen Corporate Integrity Agreement. Works closely with the management of APMS and GCO. Serves as a strategic business partner for management 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 R&D Health Care Compliance Officer who sits in the United States, This position will be located in Singapore or mainland China, or in exceptional circumstances, may be located in another key R&D market in the region.

PROFILE:

  • Senior level experienced compliance professional with strong compliance background

  • Requires strong communication, organisational, analytical and people skills

  • Broad business experience, strong preference for R&D or Medical Affairs experience, combined with a strong knowledge of HCC requirements

  • Proven ability to influence business decisions and lead business partners and HCC 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 global, regional and local l stakeholders

  • Ability to take complex business situations and develop solutions to ensure compliant growth is achieved

  • Background may include R&D, Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, or Regulatory or another similar discipline

  • Proven track record in delivering results, self starter and ability to manage complexity a must

  • Ability and willingness to work frequently during evening hours given the global nature of the role

  • Ability to work primarily in a virtual, global team, across time zones and business processes

  • Knowledge of JRD and J&J internal processes preferred

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Partner with company executive leadership and global colleagues in HCC in the US, EMEA, and Latin America to ensure that the HCC program effectively prevents and/or detects violations of law, regulations, policies, or the Code of Conduct by:

  • Establishing and chairing the APMS Compliance Committee, the committee responsible for oversight and guidance and decision making for an effective compliance program for R&D in the region

  • Translating global strategies into regional and/or local level, based on appropriate regional/local needs, goals and objectives, taking into account regional/local external regulatory trends and environment, and internal processes and requirements

  • Acting as a consultant or reviewer and approver for HCC-sensitive transactions

  • Providing and coordinating appropriate guidance, education, training, and regular communications on HCC to all covered employees, including APMS employees, Global Clinical Operations, Global Regulatory Affairs, Quality, Safety, and Johnson & Johnson Research Procurement employees, as well as external vendor personnel (e.g., FLEX associates) as needed

  • Conduct risk assessment to highlight areas of need for the region, using data-driven insights

  • Ensure that a testing and monitoring plan is in place in key R&D markets, in consideration of available resources

  • Partnering with Corporate Internal Audit, Regional Testing Operations and R&D Quality organization to ensure that responses to audit requests, and management action plans are put in place and such management action plans are reviewed regularly with the business and local HCCOs to assure progress

  • Participating in and leading investigations of non-compliance and implementing the escalation process for serious allegations, as appropriate, in collaboration with Law Department

  • Specific areas of coverage:

  • Work with local/global GCO/JRP on implementation of CIA audit mitigations – 10%

  • Serve as main contact for questions raised on global studies in countries not covered by dedicated R&D HCCOs, such as escalation of excess FMV, request for specific items outside of policy (refrigerators, computer support, etc.) for GCO global studies, complex questions from China R&D Center, and other non-study related questions in R&D – 20%

  • Review and sign off on global transactions from R&D that are budgeted to be in excess of a dollar amount (e.g., a threshold of $50,000 USD) – 10%

  • Work with JRP and local HCCOs to resolve issues pertaining to due diligence on global TPIs, and resolve complex issues with the Regional Working Group, and with BPAC and Global R&D HCCO – 10%

  • Lead framework for monitoring GCO transactions with direct report – 10%

  • Train HCCOs on R&D-specific risk areas through Boot Camps, WebEx, or other means, as appropriate – 10%

  • Train R&D business on global policies/SOPs related to global studies in countries without dedicated R&D headcount (together with local HCCO)– 10%

  • Lead global R&D RAMP input from AP/APMS Compliance Committee together with local R&D and Commercial HCCOs – 5%

  • Work with Global Policy, Procedures & Training on Communications and training – 5%

  • R&D HCCO should represent R&D HCC before the APMS LT, be a member of the R&D global HCC LT, and be an extended member of the AP Pharm HCC LT – 10%

  • Partnering with the Global/Regional/Local HCCOs and Operations and Policy, Procedures & Training teams to:

  • Develop and implement business specific policies and SOP’s; customize global/regional policies and procedures and education & training materials to reflect local requirements

  • Deliver training on specific areas of need and maintain employee certification/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 HCC community to share approaches to R&D HCC

  • Where necessary and appropriate, proactively identify areas for improvement and make recommendation to better shape the organizational support structure for R&D Global HCC LT and APMS LT

Qualifications

EDUCATION and EXPERIENCE:

  • Minimum of BA/BS required; MBA, JD or any other advanced degree preferred but not required

  • Minimum of 9 to 10 years business and/or compliance-related experience

  • Knowledge of laws, regulations and industry standards governing R&D/Medical Affairs HCC

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 organisational, 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 organisation 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);

  • Fluent in Chinese or other Asian languages (reading, writing, verbal) preferred, but not required

  • High level of integrity with good ethical core values

Primary Location

Singapore-Singapore-Singapore

Other Locations

Asia Pacific-China-Shanghai-Shanghai, Asia Pacific-China-Beijing-Beijing, Asia Pacific-Japan-Shinagawa-Tokyo

Organization

Johnson & Johnson Pte. Ltd. (8435)

Job Function

Health Care Compliance

Requisition ID

1700143866W