
Health Care Compliance Officer for Portugal
- Porto Salvo, Lisboa
- Permanente
- Horário completo
- Partner with company executive leadership to ensure that the HCC program effectively prevents and/or detects violations of law, regulations, policies, or the Code of Conduct by:
- Establishing & chairing the local Compliance Committee, the committee responsible for designing and implementing an effective compliance program and key decision making related to compliance matters
- Working together with sr. Business leaders to ensure compliant and ethical business practices are part of the day-to-day business
- Translating global strategies into local level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment.
- Assuring adequate representation in local business governance structures and establishing discussion platforms to get general business buy-in and impact analysis
- Acting as a consultant, and where appropriate, or required by the HCBI Guide 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
- Working with the J&J Government Affairs and Policy, Regulatory, Legal, and external organisations (primarily trade associations) to shape & influence the environment and industry codes of conduct, including but not limited to the MedTech Europe Code of Ethical Business Practice
- Providing and coordinating appropriate guidance, education, training, and regular communications on HCC relevant matters to all covered employees
- Conducting risk assessment activities on a continuous basis as part of the Quarterly Risk Review (QRR) Process, to detect process gaps & inconsistencies with the overall Healthcare Compliance Program
- Developing a monitoring plan to demonstrate that the HCC Program is effective and participate in execution where appropriate and engage Board participation in roll out
- Coordinating preparations and support for Corporate Internal Audits
- Coordinate the establishment of the Management Action Plan, and guide the business partners to close gaps and implement corrective actions
- Managing day-to-day allegations and investigations related to HCC
- Participating in and leading investigations of non-compliance and fostering the escalation process for serious allegations, as appropriate
- Leads and drives the locally required MENAC corruption prevention program (RCN role); cross-functional and external coordination to secure all MENAC related compliance requirements with special focus on regulatory compliance and the promotion of a culture of integrity
- Coordinate the work of surveying the ethical values for the entity or organization, as well as appropriate compliant conduct and compliant promoting
- Ensuring the participation and involvement of all, namely top and middle-management
- Coordinate the monitoring of corruption risks and deviations, risk identification, risk analysis and preventive measures, ensuring the involvement and collaboration of the entire organization
- Preparation and updating of the Risk Prevention Plan as well as monitoring its implementation;
- Ensure compliance with the deadlines for communication, disclosure and publicity of the Code of Conduct, Risk Prevention Plan and the corresponding evaluation reports of its implementation;
- Monitor and verify compliance with the requirements of the Internal Whistleblowing Channel, including the guarantees of whistleblower protection, confidentiality and reserve duties, compliance with deadlines and prevention of conflicts of interest;
- Collect and systematize information regarding training needs in the areas of ethics, integrity and prevention of corruption risks and related infractions and involvement in the process of producing training programs and monitoring their compliance;
- Verify the needs to update the various instruments of the Regulatory Compliance Program.
- Partnering with the Global/Regional HCC teams to develop and implement business specific policies and SOPs and customize global/regional policies & procedures and education & training materials to reflect local requirements
- Implement J&J MedTech systems that collect, audit, analyze, and report compliance information
- 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 global/regional HCC community to share approaches to HCC
- Minimum BA/BS required; any advanced degree preferred but not required.
- 8 years prior experience in Health Care Compliance, Finance Controllership project management is required. Knowledge of Portuguese laws, regulations and industry standards is a plus.
- Requires strong communication, organisational and analytical skills
- Broad business experience and a proven ability to influence business decisions and business partners
- Ability to manage complex business situations and continuously develop solutions that support compliant growth
- Demonstrate strong organizational, interpersonal and communication skills
- Deals well with ambiguity
- Must have a minimum of eight years of business experience (prior Health Care Compliance preferred)
- Proven track record in delivering results and being a self-starter is a must
- People management experience is preferred