Senior Manager, Healthcare Compliance - Belgium
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Promote and support adherence to all Healthcare Compliance requirements (internal and external) in the Country / Countries•Serve as country Data Privacy Officer (see next page)
Reports to (minimum):
- Regional Director or Regional Senior
- Manager – EU/EMEA Healthcare
- Compliance - direct
- Contributing to defining the regional and site compliance strategy to support the business by using a risk based approach to assessing business impact.
- Overseeing, implementing and administering (within the region/ site) our company’s compliance programs & policies and International compliance standards & procedures.
- Leading/ supporting risk assessment, investigation, monitoring & audit activities in the region/ site.•Identifying the need for specific local Compliance procedures, leading their development and implementation.
- Leading (and in coordination with relevant functions) audit corrective action implementation and Monitoring/CSA related improvement action implementation.
- Understanding Compliance and Business drivers, goals and strategy and advocating for Compliance within the business.
- Being the contact point for healthcare compliance advice within the site/ region.
- Interacting with and successfully influencing all levels of staff in the region/ site to accomplish compliance initiatives and goals.•Managing the relationship with external translation agencies or trainers.
- Balancing physical presence and amount of time dedicated to each country according to regional and site priorities.
- Act as key contact for EU/EMEA regional HCC & represent their region in GCC.
- Provide leadership, advice, guidance, direction and support to office, field based staff and applicable third parties on interpretation and implementation of the local Code of Practice & legislation and company healthcare compliance policies, procedures and practices.
- Maintain awareness of applicable laws and regulations affecting the site/ region and keep current with changes that may affect company’s compliance program.
- Participate in and monitor changes at local Trade Association/ local Code Association & in national legislation. Forward relevant information to local teams and regional groups with recommended changes to compliance framework or strategy.•Support the implementation of Corporate and EU/EMEA Compliance Programs in the site/ region.
- Conduct local Healthcare Compliance monitoring activities and follow up on improvement actions.
- Participate in the Compliance audit preparation: set up meetings with each department, prepare documentation request, facilitate audit and follow up on audit outcomes.
- Support Corporate Compliance communication strategies and participate in the development of specific communication strategies that will maximize awareness, trust and compliance with company’s business practices, policies and procedures.
- Leads/participates in compliance initiatives/projects/expert review team for EU/EMEA Healthcare Compliance.
- Review, translate (if applicable), provide comments and implement EU/EMEA Healthcare Compliance procedures and training.
- Evaluate the need for, develop and ensure implementation of defined local compliance procedures.•Develop training programs and materials for the local Code and company local compliance procedures and projects.
- Deliver Healthcare Compliance training.
- Coordinate local Healthcare Compliance training within LMS, perform training tracking and follow-up reminders.
- Customize (and if applicable translate) Healthcare Compliance presentations and communications to local audience.
- Lead meetings with local Compliance committee (3/4 per year - minutes, tracking of assistance, follow up actions) if applicable.
- Together with the finance lead conduct the CSA if applicable (set up meetings with each stakeholder, support in the implementation and tracking of improvement actions).
- Conduct local Healthcare Compliance monitoring activities.
- Review (& if applicable approve) local healthcare compliance activities in accordance with local SOPs and the local Code.
- Support/conduct the ‘free text field’ review (if required).
- Participate in regional compliance initiatives or projects if required.•Serve as the country Data Privacy Officer (see addendum).
Decision Making Authority
- Local Healthcare Compliance documents
- Local Healthcare Compliance training
- Local HCC Approvals when applicable
Interpretation / Advice on Corporate or EU/EMEA Healthcare Compliance program & processes •Healthcare Compliance communication and training materials•Delivery of healthcare compliance training
Bachelor/ Masters degree in Science or Law•Fluency in English/Dutch/French•Additional languages preferred
- At least 5 years experience in pharma/ biotech business
- 2-3 years compliance related experience preferred
- 2-3 years in development function preferred
- Defining and implementing policies, procedures and SOP’s
- Working with cross-functional teams
- Developing training materials
Knowledge about applicable laws and regulations preferred
- Subject matter knowledge
- Negotiation, collaboration, persuasion, communication and relationship building skills
- Highest level of integrity
- Discreet and able to protect confidential information
- Role model for ethical behavior
- Investigative and problem solving skills
- Ability to work in a highly matrixed organization
- Awareness of cultural diversity
- Personal and professional maturity
- Availability to travel
- Ability to prioritize
- Documentation management
- Presentation skills
- Self leadership/motivation
- Ability to work independently