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Business Analyst/Project Manager (Regulatory Operations)

For one of our clients located in the Walloon Brabant, we are looking for an experienced Business Analyst for the Regulatory Affairs department.

Job Description

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

Responsibilities
  • 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)
Requirements
  • 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