IT System Support - Regulatory Affairs

IT System Support - Regulatory Affairs






Responsibilities of the IT System Support – Regulatory Affairs

The Regulatory System Support is responsible to ensure regulatory systems in the EMEA region primarily are maintained and operate effectively. He/she will work within the Regulatory Affairs Operations International – EMEA team, based in Brussels under the supervision of the business process and information management leads for these systems.

The regulatory systems in his/her scope consist of:

  • The submission planning and execution systems, a suite of tools mainly based on MS Project and Appian. These systems support the regulatory submission planning activities of our organization.
  • The content management and collaboration systems, these are mainly built on systems such as Veeva, Documentum, Sharepoint, Office 365 and enable regulatory content management, collaboration and document exchange for authoring and archiving purposes.

Tasks involve:

  • Support process development, maintenance and improvement projects that ensure system performance and enabling new capabilities
  • Provide daily support that consist of managing end-user access, addressing queries and problems and support their resolution. Qualify the issues to be escalated to different levels of support teams.
  • Develop training material and deliver training to business end-users

Profile of the IT System Support – Regulatory Affairs

  • Minimum Bachelors Degree, preferably in IT, with a minimum of 2 years of pharmaceutical experience, preferably within the Regulatory area
  • Experience with the following tools/systems:
    • Sharepoint 365
    • Advanced MS-Excel use: design of pivot tables and graphs
    • Veeva Submissions archive
    • Opentext – Documentum D2
    • Appian
  • Knowledge of HelpDesk and Service Delivery tools and environment
  • Knowledge of MS Project
  • Proficiency with diagramming software: MS Visio
  • Experience with defining/improving operational procedures.
  • Proven Change Management experience
  • Project Management Skills
  • Excellent technical documentation skills
  • Strong interest in supporting the development of training materials and delivering trainings, either virtually and/or face to face.
  • Excellent presentation, facilitation and communication skills, both written and oral, in English

Offer for the IT System Support – Regulatory Affairs

  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees