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工作内容
With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.
Inviting applications for the role of Regulatory Information Management – Analyst
As an analyst in regulatory information management, you will have the opportunity to be a part of a passionate group and help our esteemed clients achieve data drive transformation.
Inviting applications for the role of Regulatory Information Management – Analyst
As an analyst in regulatory information management, you will have the opportunity to be a part of a passionate group and help our esteemed clients achieve data drive transformation.
Responsibilities
o Data analysis and quality assessment
o Support data transformation & enrichment activities
o Document E2E Migration Strategy and associated documentation
o Supports IDMP business process readiness
o Supports functional & user acceptance testing
o
Qualifications we seek in you!
Minimum qualifications / Skills
- Supports delivery of projects involving implementation and/or management of Regulatory Information
- Supports Data & Content Migration into Regulatory Information Management System, involves:
o Data analysis and quality assessment
o Support data transformation & enrichment activities
o Document E2E Migration Strategy and associated documentation
- Supports IDMP implementation & Maintenance
o Supports IDMP business process readiness
- Supports business analysis activities:
o Supports functional & user acceptance testing
- Communicates & collaborates effectively with different groups both on the business & IT side, including senior stakeholders – ability to articulate complex scenarios succinctly and targeted to the group
- Ensure customer success throughout the engagement
o
Qualifications we seek in you!
Minimum qualifications / Skills
- Bachelor’s degree required in science, engineering or related field (advanced degree preferred)
Preferred Qualifications / Skills
- Relevant experience in the field of Regulatory Information Management within the Pharmaceutical Industry
- Knowledge of Regulatory Information Management Processes – Document Management, Registrations Management, Submission Management
- Experience supporting implementation & maintenance of Regulatory Information Management Systems
- Experience supporting data migration, data assessment, data enrichment, data transformation and data readiness in the context of Regulatory Information Management System
- Nice to have understanding & experience with Veeva RIMS, data model and processes
- Experience with multiple RIMS platforms is an advantage: Veeva, Generis, Liquent Insight, Aris Global’s LifeSphere, Amplexor
- Knowledge of ISO IDMP Standards, SPOR & EU Implementation Guide, xEVMPD, PQCMC is an advantage
- Effective communication, presentation and interpersonal skills, ability to collaborate and engage effectively with the entire eco system (customer, vendor, Genpact)
- Knowledge on life sciences compliance and computer systems validation requirements
JobLead Associate
Primary LocationIndia-Mumbai
ScheduleFull-time
Education LevelBachelor’s / Graduation / Equivalent
Job PostingJan 28, 2022, 5:45:02 AM
Unposting DateOngoing
Master Skills ListOperations
Job CategoryFull Time
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最后期限: 20-06-2024
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