Job Description

Head of Ethics and Compliance

Belgium Pharmaceuticals Employee
Posted by Luc Decat on 07/04/2020

For one of our partners, a top 10 multinational pharmaceutical company, we have a great opportunity for a trilingual Head of Ethics and Compliance, who will be a member of the Belux management team. We are looking for someone with a background in life sciences and at least a few years experience in compliance.

Responsibilities
Provide Ethics & Compliance (E&C) support in the local affiliate with expert local insight on regulatory environment as well as identifying and escalating emerging issues in the market.    The jobholder will collaborate with every department of the Belux affiliate to ensure that all actions, initiatives will be created and executed in line with the company’s values.

  • Handle local Transparency Reporting, procedure development, training, and related compliance projects and initiatives and internal control environment enhancement.
  • Design & develop local affiliate’s healthcare compliance and ethics written standards, procedures, controls and guidance documents, including the design, development and implementation of policy infrastructure and framework in line with global Compliance Policies and Procedures.
  • Coordinate the annual Risk Management including Risk Assessment and Risk Mitigation
  • Execute the company’s monitoring and the timely resolution of audit findings and related remediation plans
  • Deploy live and web-based compliance training to the affiliate, employees, and consultants and other Third Parties
  • Participate in and provide market feedback to global / BU / BF agile projects
  • Chair Compliance related affiliate’s Committees and topics in LT
  • Manage and drive the local Ambassador Network

§ Participate in local Pharmaceutical Industry Compliance work groups to add input, gather and disseminate trends in applicable laws & regulations and healthcare best practice standards

§ Maintain in-depth knowledge for regulatory environments concerning events & HCP regulations (e.g. CNOM approval; DMOS, Mdeon visa)

§ Perform local investigations and lead during local audits

§ Follow-up on matters reported through the hotline or through other mechanism

§ Assist in the review and approval process of activities and materials

Capabilities

  • Acts as role model for the client’s values, ethics and values-based decision making
  • High interpersonal and communication skills including ability to challenge and provide guidance to business
  • Personal and professional maturity, able to motivate and inspire
  • Leading and influencing without authority, including cross-functional projects
  • Solution oriented strategic partner with a hands-on mind set
  • Ability to build alliances, bridging
  • Capable of managing and prioritizing multiple tasks and objectives
  • Manages well complexity and ambiguity
  • Mindset of curiosity, learning agility and interest in innovative ways of doing things
  • Combines enterprise thinking and business focus
  • Strong operations, process-orientation, data analytics, or technical expertise to effectively design, develop and implement compliance and relevant business processes, controls, and workflows
     

Experience

  • Minimal Bachelor’s degree, Master’s degree is preferred
  • Proven experience in healthcare and healthcare compliance, at least 4 years
  • Pharmaceutical, diagnostic or medical device experience
  • Trilingual English/ French/ Dutch
  • Lives in Belgium
  • Strong business acumen
  • Demonstrated knowledge of key laws, regulations and industry best practice standards
  • Experience in aligning potential, present and future compliance risks related to the business, including risk identification, controls & risk mitigation of potential non-compliance
  • Deep insights into ethical business decision making and good stakeholder-facing interactions and informal leadership abilities

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