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Lead Associate - Regulatory Affairs

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 Lead Associate, 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

  • Supports delivery of projects involving implementation and/or management of Regulatory Information
  • Supports Data & Content Migration into Regulatory Information Management System, involves:
    • Source to target data model mapping
    • Data analysis and quality assessment
    • Support data transformation & enrichment activities
    • Document E2E Migration Strategy and associated documentation
  • Supports IDMP implementation & Maintenance
    • E2E IDMP Data readiness - data mapping, data analysis, data transformation & integration
    • Supports IDMP business process readiness
  • Supports business analysis activities:
    • Document business & functional requirements
    • 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: Lead Associate

Job ID: LIF006532

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Dec 8, 2021

Master Skills List: Operations

Job Category: Full Time