Health Care Compliance Senior Specialist Venecenca

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This person supports the development and organization of trainings, transaction approvals, provide metrics, live monitorings, process monitorings, Business support, testing and other varied HCC functions. - This person is also responsible for supporting the area, with regards to the Compliance Program elements. This collaborator must focus on the maintenance of high HCC standards and bringing innovation. You will be responsible for: - Assist in HCC reviews and approvals for critical interaction with Health Care Professionals & Government Officials.
- Serve as point of contact of communication to the business for reviewing local transaction, requests, and documentation. - Report unplanned deviations. - Assist in software support for HCC software (HinhBond, RAMI, FIRST, among others). - Responsible for MAPs Management and governance, include management Action Plan.
- Support in the self-assessment and risk assessment processes to detect process gaps & inconsistencies. - Ensure that monitoring requirements are met by collecting and analyzing data on any interactions with HCPs / GOs. - Perform live monitorings within and outside of the cluster's countries. - Support Collection and Provide metrics 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. - Support the Compliance and Disciplinary committee for topics related to the Correction Pilar. - Support organizing training courses on HCC program pillars (prevention, detection and correction).
- Participate and support in commercial, medical and access teams (CVTs) discussions and giving a compliance perspective. - Support Third Party Intermediate (TPIs) management process with business. - Support the HCCO on the development and carry on of the HCC Compliance Committee. - Act as back-up of the HCCO in temporary absences and participate in some internal committees in representation of the HCCO.
- Participate in regional, global and/or cross-sector projects and initiatives. - Collaborating with regional pharma and local cross sector community to share approaches to HCC. - Support Implementation of local strategy and plan aligning with the businesses and J&J Office of ComplianceRequired Minimum Education: Bachelor's degree in Pharmacy, Management, Legal, Pharmacovigilance, Regulatory, Business, Accounting, Economics, Political Science, International Affairs. Other: Required Years of Related Experience: Minimum 6 years of experience in Compliance related activities with experience in Personal Healthcare, Pharmaceutical and/or Medical Devices industry(ies) and experience in Health Care Compliance is highly desirable.
- Knowledge of laws, regulations and industry standards is a benefit. - Industry related experience preferred: Health Care Compliance, Regulatory Affairs, and Compliance Experience in the Medical Device or Pharmaceutical industries. - 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 is 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