Regulatory Information Management – Senior Analyst
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 – Senior 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
• Supports delivery of projects involving implementation and/or management of Regulatory Information
• Supports Data & Content Migration into Regulatory Information Management System, involves:
o Source to target data model mapping
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 E2E IDMP Data readiness - data mapping, data analysis, data transformation & integration
o Supports IDMP business process readiness
• Supports business analysis activities:
o Document business & functional requirements
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
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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
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Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
Job: Lead Consultant
Job ID: LIF006826
Primary Location: India - Mumbai
Education Level: Bachelor's / Graduation / Equivalent
Job Posting: Jan 28, 2022
Master Skills List: Operations
Job Category: Full Time