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Business Process Expert - Regulatory Intelligence (4830) iET SA


Beschreibung: Business Process Expert - Regulatory Intelligence (4830)
Stadt: Schweiz
Firma: iET SA - Firma bewerten
Datum: 2017-10-20

Beschäftigung: bis 100% - Salär: zu verhandeln CHF - 40 Std/Woche

Arbeitsort: Schweiz

For a project at our clients site, a pharmaceutical company based in Basel, we are looking for an experienced

Business Process Expert - Regulatory Intelligence (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 analysing 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. For any questions, please contact us.

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