For one of our clients in Diegem, we are currently looking for a "Senior HCC 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 and J&J Office of Compliance
- Represent HCC in Country Value Teams/marketing planning meetings
- Liaise with legal department and external advisors
- Assisting in software support for HCC software
- Lead HCC projects and participate in regional or cross-sector projects
- Improve working methods
- Develop and conduct training for internal and external parties
- Implement business specific policies and SOP's and customize global/regional policies & procedures and education & training materials to reflect local requirements
- Implement IM systems that collect, audit, analyze, and report compliance information
- Deploy policies and procedures that align and monitor company activities to ensure compliance with government, private, legal and company HCC standards
- Implement HCC training programs, including new employee orientation, periodic training on specialized subjects, and annual refresher training
- Execute Testing & Monitoring plans and programs
- Ensure external and internal reporting requirements are met per local/regional/enterprise regulations
- Position reports into the Enterprise Wide compliance organization
- Requires strong communication, organizational and analytical skills
- Ability to work independently and in detailed manner
- Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilance, Regulatory or Auditing.
- 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.
- Ability to handle conflicts in an open and constructive manner
- Strong analytical skills, strong influencing skills, ability to deal with complexity, strategic and tactical thinking
- Proficient in English, Dutch and French
- BA/BS, advanced degree or equivalent preferred and a minimum of 6 years business experience. Preferably experience in Compliance.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16162