Beschreibung
For a project at our client‘s site, a pharmaceutical company based in Basel, we are looking for an experiencedBusiness Process Expert - Pharma / Drug Development (4830)
The ideal candidate is responsible for leading requirements analysis of systems which re-define how the company operates in regulatory affairs. You will join a highly skilled team from Regulatory Service Delivery function to deliver on the vision to globally distributed stakeholders within regulatory affairs in different divisions.
Your Qualifications:
- 12 years’ working experience in SDLC and system validation with minimum 5 years’ experience in a business analyst/process role
- 5 years working experience in Drug Development domain
- Expert understanding of business process analysis & design and system architecture concepts
- Expert knowledge of IT solutions across the industry as well as solid knowledge of Project Management
- Proven experience analyzing business needs, eliciting and documenting effective user requirements for GxP system
- Certified Six Sigma Green Belt or Similar
- Regulatory domain knowledge (specifically Registration Information Management, IDMP, SPL) is a major plus
- Excellent verbal and written communication skills in English
Your Responsibilities:
- Highlight/identify gaps in existing functionality and review requirements with stakeholders
- Develop a comprehensive requirement specification that will determine the estimate of cost, time and resources to deploy solutions
- Support in the development of project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.)
- Ensure the overall user experience is taken into account when designing and deploying new solutions and services
- Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT...)
- Ensure implemented solutions are according to specifications and fit for purpose and support super user training
- Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope
- Work with Business and Process architecture teams to understand “as-is” and define “to-be” processes
Are you ready for a new challenge and available immediately in Basel? We look forward to receiving your application in MS-Word on For any questions, please contact us: .