Business Analyst Pharma

Business Analyst Pharma

FUNCTION DESCRIPTION

Mission Context:
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.
As a Business Analyst within the Regulatory Affairs department, you conduct business analysis to support or trigger changes to the Regulatory Information Management (RIM) systems.

You review, design and document processes and data for using RIM systems in accordance with existing or new policies, procedures and legislations. You will also be a reference of RA business processes and data related to RIM systems so that you can provide support to end-users

Any projects related to the remit above require a close collaboration between regulatory affairs and IT and a process/requirements analysis.

KEY RESPONSIBILITIES

You analyse and understand business processes and information, and you identify and propose possible improvements, in accordance with regulatory processes and legislation

You identify, gather, analyse and document business requirements and needs of clients, stakeholders and management, using document analysis, interviews and workshops. You ensure that requirements and needs are clear, complete and unambiguous

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

You participate and even guide organizational change

You participate in business validation of IT systems through User Acceptance Tests, System Acceptance Tests, Data Migration Tests

Ensure good communication with stakeholders in the project (verbally and written) and collaboration with IT