Business Process Expert - Regulatory Intelligence (4830)

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.