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Senior Manager, Healthcare Compliance - Belgium  

BrightOwl managed [?] Still accepting applications

FTE : N/A
Min.Experience : N/A
Start Date : ASAP
End Date : N/A
Posted on : 01 May 2017

Project is currently here

Step 1
Application
Step 2
BrightOwl Screening
Step 3
BrightOwl Interview
Step 4
Company Screening
Step 5
Company Interview
Step 6
Budgets & Contracts
Step 7
Position filled

Project Description

Purpose
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


Responsible for:
  • 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.



Key Activities
  • 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

Outputs
Interpretation / Advice on Corporate or  EU/EMEA Healthcare Compliance program & processes •Healthcare Compliance communication and training materials•Delivery of healthcare compliance training

Qualifications
Bachelor/ Masters degree in Science or Law•Fluency in English/Dutch/French•Additional languages preferred

Experience
  • 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
Knowledge about applicable laws and regulations preferred 



Key Competencies
  • 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
  • Multi-tasking
  • 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

Others

Work from home:   Not Allowed