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We are searching for the best talent for Health Care Compliance Lead Specialist based in São Paulo, Brazil.

Purpose:

• The Health Care Compliance Lead Specialist is responsible to maintain and guaranteeing Healthcare Compliance program and transactions for J& J Brazil Organization. This person supports the development and organization of training, communications from HCC, provide metrics, transaction approvals, responsible to HCC’s policies and SOP, Business support and other varied HCC functions.
• This person is also responsible for supporting the area, in regards the Compliance Program elements. This collaborator must focus on the maintenance of high HCC standards and bringing innovation.
• This professional will support J& J BR Business in advices and risk analyses related projects, interactions with HCPs, GOs and HCOs

This position reports to the HCC Sr Manager and located in Brazil (São Paulo/JK)

You will be responsible for:

• Assist in HCC reviews and approvals for critical interaction with Health Care Professionals, Health Care Organizations & Government Officials
• Serve as point of contact of communication to the business for reviewing local transaction, requests, and documentation.
• Organize and implement training courses, including new employee onboarding, periodic training on specialized subjects and annual refresher training
• Support the HCC Sr Manager with implementation of Communication and Training strategy
• Support to maintain training and communication records, maintain employee certification and training attendance records
• Assist in HCC reviews and approvals for any interaction with Health Care Professionals & Government Officials
• Responsible in the harmonization, preparation, updating and implementation of all HCC written policies and procedures on an ongoing basis
• Work close to Global/Regional HCC organizations to implement business specific policies and SOP’s and customize education & training materials to reflect these requirements
• Support, collect and provide metrics related HCC activities
• Support HCC manager in activities related to governance process in HCC area
• Carrying out day-to-day tasks such as data collection, analysis and reporting
• Focus on the prevention, correction and detection pillar
• Support HCC Regional about TPI Due Diligence and others topics about Brazil Business
• Responsible for governance and oversight of management action plans to enhance business and compliance controls to mitigate risks related to FCPA, interactions with Government Officials, Health Care Compliance, and third parties representing the company in such interactions
• Support in the self-assessment and risk assessment processes to detect process gaps & inconsistencies
• Support to ensure that monitoring requirements are met by collecting and analyzing data on any interactions with HCPs / GOs
• Support Collect and Provide metrics related HCC activities
• Support HCC in activities related to governance process in HCC area
• Participate in regional or cross-sector projects/initiatives
• Collaborating with regional pharma and local cross sector community to share approaches to HCC
• Support Implementation of local strategy & plan aligning with the businesses and J& J Office of Compliance
• Report unplanned deviations and support the HCC Sr Managerin Managing day-to-day inquiries, allegations, and investigations
• Assist in software support for HCC software (Epic, Highbond).
• Support the HCC Sr manager and HCCO in the self-assessment and risk assessment processes to detect process gaps & inconsistencies
• Support in the following up on the Management Action Plan if applicable

Deals well with ambiguity and demonstrates strong organizational, process and interpersonal skills. Ability to work well between functions and across all levels of the business and effective time management skills are essential. Ability to work independently and in a detailed manner. Ability to work well in teams.

This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent(s).

Qualifications / Requirements:
Required Minimum Education: Bachelor's degree in Pharmacy, Administration, Legal, Pharmacovigilance, Regulatory

Required Years of Related Experience: Minimum 5 years’ experience in Pharmaceutical and/or Medical Devices industry(ies) is desirable.
Experience in Health Care Compliance, Compliance areas, are recommended.

Required Knowledge, Skills and Abilities:

• Knowledge of laws, regulations and industry standards is a benefit
• Industry related experience preferred: HCC, 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 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
• Basic Spanish