IT Business Analyst - Pharmaceutical Industry, GxP

Business Analyst - Regulatory Information Management, Pharmaceutical Industry, GxP

Leading global Pharma client require an experienced BA to help with the implementation of a Regulatory Information Management System.

Summary:

We are looking for an experienced business analyst to lead requirements analysis of a new system which re-defines how our client operates in regulatory affairs. You will be working on a strategic initiative with the mandate to deliver a strategic product which will bring transformative change to the business domain and will allow the organisation to realize a competitive advantage. You will join a highly skilled team of analysts, architects and business SMEs to deliver on this vision.

The project, which will implement an OTS regulatory information management (RIM) system, requires daily interaction with the business, IT and vendor team. The Business Analyst has a key role in describing and translating business requirements in a way that they are clear, complete and easily understood by the business and vendors. The BA is actively involved in design and process discussions, to ensure the implementation fulfills the business requirements with a key focus on purpose, consistence and usability.
The BA will also assess jointly with the business and the vendor team that the requirements are met and the implemented solution is fit for purpose. Good technical background in conjunction with proven BA techniques and well developed interpersonal skills are key success factor in this role.

Principal Responsibilities:

*Leading business requirements sessions for a functional/process area topic with a team of business users including: utilizing necessary analytical tools that result in aligned concepts, business processes and requirements with the business team; providing guidance to the business team to ensure consistency of the overall solution; continuous management of user expectations.
*Owning and managing user requirements specifications for a functional area, ensuring that the complexity of the requirements is documented in concise, scalable manner that is easily understood by both the business team and vendor team
*Owning the delivery of requirements for a functional area including: providing continuous clarifications to vendor team on requirements during build, and validating the implementation of requirements from a usability perspective.

Mandatory Skills and Experience:

*5+ plus years experience in business analysis
*Excellent knowledge of the processes in the regulatory space
*Background in life sciences with knowledge of the pharma drug development processes
*Ability to discuss and negotiate and agree on proposed design options with key stakeholders in the organization
*Proven experience analysing business needs, eliciting and documenting effective user requirements for GxP system
*Excellent verbal and written communication skills in English
*Experience working with global teams

Additional Requirements:

*Regulatory domain knowledge (specifically submission and registration management) is a plus

Please apply now for more details!