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, This is used for its management capabilities of all types of content by storing content securely, governed by compliance rules.
The Business Analyst will be allocated to RIMS Program and will work closely with the Project Manager to describe user-stories, User Mapping Rules, perform Data Analysis, and Testing/Validation activities. This includes the analysis of the demand, the implementation of the solution through Configuration and Testing. The Business Analyst will contribute for the Training Material preparation..
What you’ll do
- Analysis of business needs and translation into user-stories and business rules
- Identify the Master Data needed to be loaded into the system for Go Live, identify data sources and develop a loading strategy/process
- Coordinate analysis and activities with the Project Manager/Stream leader
- Ensure good communication with stakeholders in order to stablish/review process and collect user-stories (verbally and written)
- Solution-oriented and problem-solving spirit
- Solid analysis and synthesis capability
- Data & Process Analyst
- Testing preparation & Execution
- Data verification & Validation
- Contribute for the delivering a training Material
- Engineer’s or Master’s degree (preferably in IT or Science)
- Customer oriented
- Great motivation and team spirit
- Fluency in spoken and written English
- 8 to 15 years experience in System integration/implementation projects
- Experienced in Business and System Analysis
- Experience with Agile methodologies and user-stories definition
- Ability to quickly understand business stakes of client's organization and industry
- Strong Microsoft Excel skills (Data analysis & Data validation)
- Experience in Pharma Industry/Regulatory is a plus