freelance
Regulatory System Support Reference number: 1431
Last update: 18-05-2020, 15:12
Region: Brussels
Sector: Pharmaceutical
Education: Minimum Bachelor’s Degree, preferably in IT, with a minimum of 2 years of pharmaceutical experience, preferably within the Regulatory area
Contract type: This is a 3 month assignment for a full time employment or a 6 month assignment for a part-time assignment
Job description
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 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.

He/she will support and work in close collaboration with his key stakeholders:
• Regulatory teams in the EMEA region primarily;
• HQ business system owners (Regulatory systems)
What you’ll do
  • 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.
  • Maintain a knowledge base of issues and resolutions
Required Skills
  • Minimum Bachelor’s Degree, preferably in IT, with a minimum of 2 years of pharmaceutical experience, preferably within the Regulatory area
  • Experience with the following tools/systems:
    • MS Project : good to excellent knowledge required
    • Office 365 : mostly MS Excel (pivot tables and graphs)
    • Sharepoint 365:
    • knowledge of JIRA is a plus
  • Business systems support skills (e.g. ITIL)
    • Knowledge of HelpDesk and Service Delivery tools and environment
    • Experience with defining/improving operational procedures.
    • Project Management Skills
    • Process Management Knowledge
    • Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines, in a matrix environment
    • Excellent technical documentation skills
    • Proficiency with diagramming software: MS Visio
    • Well organized, highly motivated process and results driven
    • Excellent presentation, facilitation and communication skills, both written and oral, in English
    • Flexible, pro-active and a team player
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