Business Analyst RIM

Business Analyst RIM

Vacancy expired!

• Must have experience in the Veeva RIM Registrations module or at least Veeva RIM/QMS implementation experience.

• 5 - 7+ years' experience in Regulatory Information Management systems and Pharma/Biotech Drug Manufacturing Process.
• Analyze current state challenges with Regulatory Affairs CMC and QA (both Clinical and Commercial) business process – in the areas of planning, submission, and batch release
• In-depth understanding of Regulatory process, for both clinical and commercial, as well as US and EU regulatory process and how it impacts the key business processes regarding initial application filings, clinical study changes, and post-marketing changes, etc.
• Develop a future business process for RA CMC data entry and QA batch release related to planning, submission, and batch release – in lieu of current state challenges and areas of improvement
• Facilitate workshops designed to define and document core business processes focusing on client's Regulatory Affairs CMC and QA future requirements
• Define future approach to implement out of the box Product Docket/ Regulatory Information Management packaged software
• Highlight and prioritize pain points across people, process, data, and technology and identify opportunities for improvement across end-to-end Regulatory, Supply Chain, and Quality business process
• Author critical deliverables within the business process workstream e.g. SIPOCs, KPIs/metrics, and Process Maps, GPID implementation roadmap
• Help develop/refine Key Performance Indicators, metrics, and criteria to measure and assess RA CMC and QA operational performance
• The ideal candidate must have hands-on experience in implementing the Veeva RIM Registrations module or at least Veeva RIM/QMS implementation experience.