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This position is responsible to support the HCC Officer to ensure that the HCC program effectively prevents and/or detects violations of law, regulations, policies, or the Code of Conduct in business interactions with health care professional, government officials or third parties representing Janssen Mexico in such interactions. Serve as a strategic business partner to assure that the company culture of compliance is a natural element in day-to-day business.
This person is also responsible for supporting the area, in regards the Compliance Program elements: have responsibility for the operationalization of the Compliance area and effective management of the compliance program in Janssen Mexico. Will serve as an internal compliance expert supporting ethical decision-making capability providing advice for business strategies and initiatives, acting as a consultant in day-to-day activities.
This collaborator must focus on the maintenance of high HCC standards and bringing innovation.
Major duties and responsabilities:
- Responsible for building and maintaining, as guided by the HCCO, an effective compliance program to ensure its business activities comply with HCC/HCBI laws, regulations, industry standards, and company policies related to the promotion and marketing of products and services, interactions with health care professionals and government officials, including, as applicable, U.S. anti-kickback and false claims statutes, Foreign Corrupt Practices Act (FCPA) and other anti-corruption laws, compliance with corporate integrity agreements, deferred prosecution agreements, or other settlements, as applicable.
- Drive the risk assessment processes and respective mitigation plans..
- Act as a consultant and approver, as needed, for business activities involving HCC risks.
- Engage with functional leaders, for covered function areas: Ensure business projects have enough HCC feedback by participating in the CVTs as support function. Responsible for the reviews and approvals for critical interaction with Health Care Professionals & Government Officials Effectively accompany the access interactions ensuring the properly risk detection and mitigation. Care the HCC adherence in business alliances. Responsible for the reviews and approvals for critical interaction with Health Care Professionals & Government Officials Be the expert and a leader in the implementation of orphan’s drugs projects and interactions review, risk detection and approvals.
- Lead prevention initiatives such as the strengthen of training, communication and policies and procedures to ensure the materials fit into the needs and business context, deliver frequent trainings to covered employees at various levels. Develop and Update the annual Training Plans on HCC Topics ensuring the focus in the critical topics detected.
- Support detection and correction activities to identify warning signals and/or gaps and provide meaningful feedback to business leadership so that appropriate corrective actions are taken accordingly including the follow up of management action plans Manage and implement innovation tools that ensure the earlier detection. (e.g. chatbot)
- Support to the organization on the management and mitigation of Conflict of Interest.
- Responsible of the Metrics analysis applied related HCC activities.
- Support HCC in activities related to governance process in HCC area
- Carrying out day-to-day tasks such as data collection, analysis, and reporting
- Report unplanned deviations and support the HCC Officer in Managing day-to-day inquiries, allegations, and investigations
- Support the HCCO to develop the annual Plans for the HCC areas
- Organize and implement training courses aligned with detection pillar
- Identify and address the top or evolving opportunities and risks in our sectors, including Patient Support Programs, HCPs as Influencers and Speaker Programs
- Drive the culture of accountability strategy
- Ensure HCC projects have sufficient stakeholder feedback and buy-in
- Ensure collaboration and best practice sharing with internal HCC stakeholders
- Stimulating and contributing to innovative approaches towards HCP’s and GOs consistent with the HCC/HCBI guidelines and framework.
- Providing metrics as required
- Participate in regional or cross-sector projects/initiatives representing Mexico.
- Respond to complaints and reports of potential misconduct through appropriate investigations and escalations, consistent with Company policies and procedures. Advise HCC leaders and business stakeholders of potential compliance risks, compliance related incidents and investigations, trends, root causes, and recommend and implement appropriate action plans.
- Assist investigation related to covered business areas.
- Interface with legal counsel regarding HCC requirements and interpretation.
- Interface with the global/regional HCC community to share approaches to HCC.
- Required Minimum Education: Bachelor's degree.
- Other: A Compliance certification will be considered but is not a requirement.
- Required Years of Related Experience: Minimum 8 years’ experience in Compliance, Legal, Finance, or Regulatory related areas/consultancy is required. At least 3 at the Pharmaceutical industry is preferable.
Required Knowledge, Skills and Abilities:
- Previous experience working in a corporate environment, pharmaceutical industry is desired.
- Knowledge of laws, regulations and industry standards is required.
- Deals well with ambiguity and demonstrates strong organizational, process and interpersonal skills. Ability to work well in teams, between functions, across all levels of the business and effective time management are critical. Ability to work independently and in a detailed manner. Ability to work well in teams.
- Effective on self-management skills and resilient and innovative orientations.
- Ability to lead by influence and contribute with the team growth.
- Capacity to connect with the business at different levels, demonstrating good organizational acumen, interpersonal skills, and sensibility to apply the enforcement accordingly. Ability to comprehend and interpret legal documents.
- Ability to manage conflicts in an open and constructive manner
- Must be able to work effectively also under time pressure
- Proven track record in delivering results, self-starter and ability to manage complexity a must
- Ability to work independently and in a detailed manner. Resilient and hands on
- Requires strong communication, organizational and analytical skills
- Fluent English is required
- Risk assessment and management while take decisions.
- Data analytics capabilities is a plus
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