Description
Description:
Our client is a global vaccine research, development and production company, that employs over 11,200 people worldwide, of which 7,500 in its three Belgian sites: Rixensart, Wavre and Gembloux.
The Regulatory Affairs (RA) department manages all activities related to regulatory data and information management with worldwide health authorities.
To make this activity possible, a large amount of IT applications are used, eg a database for tracking regulatory activities.
A Data Integrity Assessment on these applications is currently on-going. After a gap assessment related to Data Integrity a gap remediation prioritization will take place.
You will Require
- Demonstrated understanding of data/information quality principles and practices
- Knowledge of Data Integrity and General Data Protection Regulation skills
- Good understanding of companywide information systems
- Strong technical skills, with the ability to understand implications of processes and data flows and how they related to computerized systems
- You communicate and share the outcomes of your analysis, and get appropriate validation
- You collaborate with project teams and get input from Subject Matter Experts when necessary
- You interact and communicate with stakeholders within your department as well as in any other department involved in your projects. Excellent Stakeholder Management and Engagement skills.
- You participate to and even guide organizational change
- Ability to assess situations to determine importance, urgency and risks and make clear decisions or recommendations which are timely and in the best interest of the organization
- Ability to assess problems/situation to identify causes, gather and process relevant information, generate possible solutions
Profile:
Education
- University level (IT, Science or Management background) or equivalent by experience.
- Master with a specialization in Data Quality/Analytics would be a plus
Skills & Experience
- More than 5 years in a multinational environment
- Good leadership skills
- Quickly understand business issues and data challenges of client's organization and industry
- Great motivation and team spirit
- Customer oriented
- Autonomous
- Fluency in spoken and written English (Project Language will be English)
- Excellent communication and presentation skills
Beneficiary skills/experience (not mandatory but assests):
- Experience with databases used for tracking Regulatory/regulated information
- Experience with document management systems (in particular Documentum)
- Experience with Pharmaceutical Industry, in particular Regulatory Affairs