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Regulatory Information Management – Associate 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 – Associate 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
•    
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: Technical Associate

Job ID: LIF006827

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Jan 28, 2022

Master Skills List: Operations

Job Category: Full Time