Beschreibung
For a project at our client ‘s site, an international pharma company based in Basel, we are looking for an experiencedBusiness Analyst - Pharma Regulatory / GxP (6050)
In this role, you will lead the requirements analysis of a new system which re-defines how the client operates in regulatory affairs.
Your Qualifications:
• 5+ plus years’ experience in business analysis and working with global teams
• Proven experience analyzing business needs, eliciting and documenting effective user requirements for GxP system
• Background in life sciences with knowledge of the pharma drug development processes
• Very good understanding of pharma regulatory domain knowledge
• Regulatory domain knowledge, specifically submission and registration management is a plus
• Ability to discuss, negotiate and agree on proposed design options with key stakeholders in the organization
• Excellent verbal and written communication skills in English
Your Responsibilities:
• Leading business requirements sessions for a functional/process area topic with a team of business users
• 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
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