Healthcare Compliance Specialist
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For one of our customers, active in the pharma sector in Diegem, we are looking for an Senior Health Care Compliance Specialist.
The Senior HCC Specialist runs Healthcare Compliance programs and transactions for the Medical Devices Benelux HCC organization. She/he supports planning, trainings, assessments, testing, monitoring and other diverse HCC functions. This person is also responsible for maintaining existing programs and implementing activities related to Management Action Plans.
• Organizing and implementing training
• Maintain employee certification and training attendance records
• Support the HCC operations group in implementation of education, training, and regular communications on HCC to all covered employees, including local sales, marketing, finance, HR, managers, supply chain and directors at the local level
• Serve as the first line of communication to the business for reviewing local requests and documentation
• Assisting in HCC reviews and approvals
• Carrying out day-to-day tasks such as data collection, analysis and reporting
• Supporting new procedure harmonization and implementation
• Assist in the harmonization, preparation, updating and implementation of all HCC written policies and procedures on an ongoing basis
• Assist in implementation of modifying global strategies into regional and local level and where needed sector level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment
• Support the HCC Officer in the self-assessment and risk assessment processes to detect process gaps & inconsistencies
• Support the implementation of local testing & monitoring plan to demonstrate that the HCC program is effective and participate in execution where appropriate
• Assisting in coordinating preparations for Corporate Internal Audits
• Assist in the implementing and following up on the Management Action Plan as assigned by the HCC Officer
• Report unplanned deviations and supporting the HCC Officer in handling day-to-day inquiries, allegations and investigations
• Implement the escalation process for serious allegations, as appropriate
• Collect and provide metrics the HCCO and Operations group as assigned
• Support Implementation of country/cluster strategy & plan aligning with the businesses
• Represent HCC in Country Value Teams/marketing planning meetings
• You have strong communication, organizational and analytical skills
• You are able to work independently and in detailed manner
• Your background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilance, Regulatory or Auditing.
• You have a proven track record in delivering results, self-starter and ability to handle complex and ambiguous situations
• Industry related experience preferred: HCC/GCC, Regulatory Affairs, and Compliance Experience in the Medical Device or Pharmaceutical industries.
• You are able to handle conflicts in an open and constructive manner
• You have strong analytical skills, strong influencing skills, ability to deal with complexity, strategic and tactical thinking
• You are fluent in English, Dutch and French
• A contract of undetermined duration with Manpowergroup Solutions
• An interesting salary package with extralegal advantages (meal vouchers, group and hospitalization insurance)
• The opportunity to work in a challenging environment and real opportunities for individual growth
Please send your CV to email@example.com