Description
IT project manager in Regulatory information system
Function:
- You partner with Regulatory, Supply Chain and IT stakeholders, collect & challenge IT needs, assess the impact of the request, propose solutions and alternatives per IT governance process, including business case preparation
- You coordinate small or medium size GxP approved projects or change requests simultaneously
- You ensure flawless operation of Product Registration & IDMP from an IT perspective
The projects or changes are related to
- Artworks and Labeling
- Regulatory information management
- Product registration & related legislations
You will work & communicate with Stakeholders, IT and non-IT.
- Your collect the requirements, challenge, design and document them
- You evaluate or use data/process mining or Artificial Intelligence techniques in the regulatory domains, liaising with the Advanced Analytics team
- You work with functional owners and ensure the design fits the application in place
- You support the developers who implement the changes
- You coordinate the test Matrix and ensure they are executed and show evidence.
- You make sure the necessary documentation is in place and add where needed
- You support the development process (provisioning, troubleshooting, monitoring, etc.) and are responsible for deployments
- You identify potential automations where possible
- You like being challenged
Skills:
- Autonomous but team player
- Strong organization skills
- IT minded
- Knowledge of regulatory systems is a plus.
- Experience in International GxP Pharma industry environment (at least 3 years preferred)
- Experience in Computer Systems Validation preferred
- Openness to take on support of other systems as needed
- Excellent command of English language (verbal and written); French is an advantage
- Strong customer focus - 'Sense of urgency'
- Strong communication & collaboration skills (with colleagues, other IT areas, with vendors, etc.)
- Focused on quality & eye for detail
Workload:
40hours/week
Location:
Office based in South Brussels (Walloon Brabant).
Planned time frame: 6 to 12-month contract, starting Jan 2018