Leads and drives strategy and execution of the Health Care Compliance (HCC) program to ensure business practices and activities are in compliance with related Johnson & Johnson (J&J) internal guidelines, applicable laws and regulations, and anti-corruption laws including the U.S. Foreign Corrupt Practices Act.
Provides strategic and operational support to lead and drive robust compliance program for MedTech Indonesia (ID) market (MedTech; Vision Care and Surgical Vision). Oversees and manages business activities from the HCC standpoint; and serves as a strategic business partner for senior leaders at the local levels and coach towards all covered employees to assure that the company/group culture of compliance is a natural element in day-to-day business.
This role is also responsible for oversight, operational excellence, and enhancements of a Compliance framework and program across the SEA HCC. This role is accountable for driving collaboration, consistency, and simplification across the organization through active engagement with the SEA HCC LT and SEA MedTech Franchise leadership. Responsibilities will also include executing strategy and leveraging solutions and alignment across the enterprise as appropriate to create efficiency and minimize risk.
This position reports to the MedTech SEA Franchise and Sub-Cluster Lead and will be a member of the ID Leadership Team (LT).
Major Duties & Responsibilities
- Partner with MedTech, Vision Care and Surgical Vision ID LT to ensure that the HCC program effectively prevents and/or detects violations of law, regulations, policies, or the Code of Business Conduct by:
- Establishing and chairing the Compliance Committee, the committee responsible for designing and implementing an effective compliance program and key decision making
- Creating and deploying and country specific strategies to address the evolving business needs while minimizing risks
- 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, shaping solutions, and where appropriate, or required by the J&J International Health Care Business Integrity Guide (HCBI Guide) assure 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, including the LTs
- Conducting self-assessment and risk assessment processes to detect process gaps & inconsistencies
- 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 guiding the business partners to close gaps and implement corrective actions
- Managing day-to-day allegations and investigations in collaboration with the global/regional HCC stakeholders and the Litigation Group, Law Department
- Participating in and/or leading investigations of non-compliance and implementing the escalation process for serious allegations, as appropriate
- Providing metrics for the HCC Program to J&J Office of Health Care Compliance
- Performing all necessary and appropriate duties to support the business leaders as strategic partner in compliance matters.
- This role will be responsible for strategic oversight, operational excellence, and enhancements of a Compliance framework and program across the Health Care Compliance organization
- Identify and execute on opportunities for leveraging and driving efficiencies among compliance functions, SEA countries including SEA MedTech Franchises
- Policies and SOP's and customize global/regional policies & procedures and education & training materials to reflect local requirements
- HCC training programs, including new employee orientation, periodic training on specialized subjects, and annual refresher training (employee certification and training attendance records)
- Ensure internal reporting requirements are met per enterprise requirements and schedule
- Bring consistency across organization (within SEA, MedTech Franchises and APAC or globally) where appropriate
- Project manage HCC projects at the enterprise, global or regional level that are primarily business facing, including projects coming out of risk assessment
- Manage Management Action Plan (MAP) timelines and drive closure; drive consistency related to MAP creation, documentation, and resolution; track disciplinary actions
- Coordinate Risk Management and Monitoring process align with GACS and country plans
- Coordinate TPI Management projects in ID and beyond
- Ensure that information and best practices are shared across the SEA HCC to create greater visibility and input to cross-region HCC teams
- Provide standard data and clear expectations for local HCCO for country reviews or her deep dives by senior leaders on behalf of the CCO; attends country reviews with CCO
- Enables SEA HCC perspectives are provided for key compliance program infrastructure, such as data automation projects, dashboard projects, TPI management and oversight, etc.
- Collecting and evaluating information across SEA HCC (e.g., to assist SEA HCC LT in driving accountability)
- Support coordination of Quarterly Risk Reviews with key stakeholders (HCC VPs)
- Connect across regions to leverage knowledge and solutions created by other teams
- Facilitate quarterly updates on cross sector projects and assist in transitioning completed projects to base business
- Communication strategy and implementation
- Drive efficiency and Coordination of HCC Leadership Team meetings; including follow-ups
- Partner with other sectors within HCC
- Interface with Law Department regarding HCC requirements and interpretation from local, regional and global perspective
- Interface with global/regional HCC community to share approaches to HCC
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