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Business System Support Lead

Keyrus Biopharma

Brussels, Belgium

Scope:

The Business system support Lead is responsible to ensure the content and collaboration systems for the regulatory teams in the EMEA region are operating effectively.

The Lead will work in the Regulatory Operations and Quality Management – EMEA team, based in Brussels.

The content and collaboration regulatory systems are constituted of regulated content management systems (documentum based systems), used to create and maintain components aimed for regulatory dossiers; by the portfolio and submission planning systems based on MS project; by a series of share-point sites for enabling collaboration and document exchange across the EMEA region and by an exchange platform for collaboration with external partners.

The Lead will be responsible to maintain access for the authorized users, ensure the system process and user documentation are maintained according following regulatory change.

Role and main tasks:

  • The Lead will support and work in close collaboration with his key customers; the regulatory teams in the EMEA region; collaborate with his stakeholders, the HQ business users and system leads for regulatory systems, and partner with the IT teams;
  • Provide project management support to analyze, develop and implement solutions for addressing needs and opportunities coming from the regulatory affairs and regulatory operations area;
  • Maintain system process, performance and the related documentation (process and training);
  • Support business areas by maintaining user access and addressing queries, issues and system performance problems;
  • Develop training material and deliver training to business users;
  • Proactively solve problems.

Profile:

Education:

  • Bachelor’s Degree, preferably in IT, with a minimum of 3 years of regulatory experience or an advanced degree and a minimum of 2 years of regulatory experience.

Required skills:

  • Project Management Skills;
  • Knowledge of MS Project;
  • Process Management Knowledge (e.g. six sigma);
  • Must have demonstrated experience assessing and enabling process change;
  • Change Management Knowledge;
  • Must have a broad range of knowledge of processes and systems;
  • Minimum: experience with Documentum and Sharepoint;
  • Demonstrated ability to collaborate, communicate, supervise and coach across cultures, organizational levels and disciplines;
  • Excellent technical documentation skills;
  • Demonstrated communication skills (oral and written) in English.

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