We are looking for an Experienced IT Project Manager for IT-projects for the department of Regulatory Affairs.
The IT Medical Development team defines the IT-Regulatory Affairs roadmap and manages the IT-applications and projects for the Regulatory Affairs team. The team is also the IT point-of-contact for the Regulatory Affairs team for all IT questions and requests.
The candidate will work on the several projects and interact with Regulatory Affairs stakeholders, IT technical teams on-site and remote.
The main tasks will be:
• Drive and manage the implementation & validation activities of IT-projects for the Regulatory Affairs department:
- Manage with the RA project manager collection of user requirements
- Follow-up of the different (external) technical team(s) during implementation
- Coordinate with the validation lead with design, review, and approval of test plans and test scripts
- Follow-up (cost, time, scope) of the project & communicate relevant info & statuses to the stakeholders
• Proven experience with IT- projects in a GxP environment (at least 3 yrs)
• Proven experience with RA-processes and terminology in a (bio)-pharma environment (at least 3 yrs)
• Proven experience with RA-tools: Regulatory Affairs system (e.g. Veeva RIM Registrations, Liquent Insight Manager) (at least 3 yrs)
• Ability to communicate with technical and non-technical experts, RA stakeholders
• Driven by the motivation to deliver results
• Ambition to work independently and to structure workload
• Proven IT experience: MS Office, project management tools
The position is for Braine site and the candidate can work remotely (max 20%)
wat bieden wij?
We offer an attractive salary with extra-legal advantages :
- Group insurance - Hospitalisation insurance - Meal vouchers of 7 euros gross per working day - Reimbursement km or company car - Monthly allowance (50 euros net per month) - A 13th month - Training - Etc