Job Title : Lead Associate-Analytics-LIF008482

Location : India-Mumbai

Lead Associate-Analytics-LIF008482With 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  

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 

Qualifications we seek in you! 

Minimum qualifications / Skills 

    Bachelor’s degree required in science, engineering or related field (advanced degree preferred) 

Preferred Qualifications / Skills 

A minimum 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 AssociatePrimary Location India-MumbaiSchedule Full-timeEducation Level Bachelor’s / Graduation / EquivalentJob Posting Aug 2, 2022, 7:17:03 AMUnposting Date OngoingMaster Skills List OperationsJob Category Full Time