IT Project Manager
We are looking for an Experienced IT Project Manager for IT-projects for the department of Regulatory Affairs.
The IT Med Dev (Medical Development) team defines the IT-RA (Regulatory Affairs) roadmap and manages the IT-applications and projects for the Regulatory Affairs team @ the client. The team is also the IT point-of-contact for the Regulatory Affairs team for all IT questions and requests.
The position is for Braine site and the candidate can work remotely (max 20%).
This is a full time role.
Starting date: the latest 1 Oct
Initial contract: Beginning October 2019 to end December 2020
• 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 project management experience (at least 3 – 5 yrs)
• 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