For one of our clients located in the Walloon Brabant, we are looking for an experienced Business Analyst for the Regulatory Affairs department.
The Regulatory Affairs (RA) department manages all activities related to regulatory data and information management with worldwide health authorities.
To make this activity possible, several processes have been put in place and a large amount of IT applications are used to facilitate the application of these processes.
As Business Analyst/Project Manager, you work closely with IT Project Manager to design, implement applications & systems to support regulatory business processes. This includes the analysis of the demand, the realization of the application through customization/development and testing.
You work with key stakeholders to map current processes and organize task forces to define and implement process improvements. In addition, you are responsible for training and support activities (response to questions from users)
Finally, you support the organization by analyzing (as business analyst) and managing and/or coordinating process changes (Veeva, TMF, RIMS, CTSM, SSU, eCTD, offshoring…) and organizational changes
You draw models for the business processes (process flows)
You moderate workshops with business experts
You capture the User Requirements
You formally document User Requirements
You coordinate analysis and activities with IT Project Manager
You ensure good communication with stakeholders in the project (verbally and written)
You draft new procedures based on new business processes & user requirements
You create training material and reference guides
You evaluate new system packages for implementation
You write & run user test cases
You provide support to end-users
You design and generate reports for stakeholders
You design and maintain KPIs on system data
You design and QC metrics to monitor system data quality
You liaise with other Regulatory Operation teams for system inter-operability
You work with external partners and authorities for data update (offshoring) and data exchange with authorities (e.g. EMA for XEVMPD, IDMP, TMF/SSU/CTSM, RIMS)
You have a Master Degree in Bio-Engineering (or equivalent by experienc) and at least 5 years Experience as Project Manager
You are fluent in English and in French
You have a good analytical mindset
You quickly understand business issues and data challenges of client's organization and industry
You have strong interviewing skills
You are solution-oriented and have problem-solving skills.
You have solid analysis and synthesis capability.
You have a great motivation and team spirit