Ethics and Compliance Officer Global Medical Office

2 tygodni temu

Wrocław, Województwo dolnośląskie, Polska Fresenius Medical Care Pełny etat

Position Purpose:

The Global Ethics and Compliance Officer Global Medical Office is pivotal in providing comprehensive compliance support for the company's Global Medical Office (GMO), ensuring that compliance standards are rigorously met, e.g., for related scientific activities including establishing Medical Advisory Boards, selection of scientific speakers, as well as managing the interactions related to the execution of the clinical research activities. This role is responsible for the strategic oversight, development, implementation, and maintenance of a robust global compliance program. This encompasses the management of resources, policies, procedures, templates, training programs, controls, and monitoring systems, all supported by advanced technical tools.

Primary Duties:

Global Compliance Program:

  • Optimize and implement global compliance processes, procedures, policies, and training, allocating resources efficiently.
  • Implement and maintain compliance instruments (processes, policies, training, IT tools) globally.
  • Monitor and adapt the Global Compliance Program based on regulatory developments through research and participation in relevant events.

Projects and Operations:

  • Oversee relevant projects and operations, ensuring adherence to scope and timelines.
  • Develop and maintain communication tools and document management processes for compliance-related content.
  • Participate in compliance and investigation training and networks for professional development.
  • Design, implement, and improve a compliance framework to monitor, assess, and mitigate risks, ensuring regular reporting and updates.
  • Analyze business transactions and structures to identify compliance risks, design mitigating actions, and track their status.
  • Communicate necessary information to all Compliance Departments to ensure sound collaboration.
  • Proactively contribute to project work and additional tasks as assigned.

Reporting and Collaboration:

  • Provide regular and ad hoc reports to the supervisor regarding areas of responsibility.
  • Ensure regular information flow for effective collaboration within the Global Compliance Department.
  • Conduct regular reporting to internal and external stakeholders in alignment with the supervisor or project manager.

Qualifications:

  • Master degree or equivalent qualification in Business, Economics, Law or similar specialization is beneficial
  • Compliance related Certifications (such as CCP) are beneficial.
  • Minimum of 6 years of general professional experience, of which a minimum of 4 years of operational experience in the field of Compliance / Risk Management, Regulatory, preferably in the healthcare industry is beneficial.
  • International and Medical Office experience is desired.
  • Good negotiation and mediation skills as well as confidence to handle difficult conversations, pressures and deadlines.
  • Solid degree of flexibility and willingness to travel internationally.
  • Fluency in English and the language locally spoken.
  • Solid command of MS-Office and ability to adapt new technologies.

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