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We are Hiring - Lead Consultant-RA

2.00 to 5.00 Years   Mumbai City   02 Dec, 2022
Genpact India Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other SoftwareSales / BD
EmploymentTypeFull-time

Job Description

    Lead Consultant, Regulatory Information ManagementWithin our Global Regulatory Affairs business, we are excited & committed to build an industry leading Regulatory Information Management & Governance capability to help our clients deliver medicines faster to patients. With the sky as the limit, we are passionate, resilient, and relentless in our pursuit.We are now 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:
    • Source to target data model mapping
    • Data analysis and quality assessment
    • Support data transformation & enrichment activities
    • Document E2E Migration Strategy and associated documentation
    • Supports data operations in RIMS platform:
    • Creation and management of regulatory information during lifecycle management of a medicinal product
    • Ensuring data quality & standards in the management of regulatory information
    • 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 youMinimum qualifications
    • Bachelors degree required in science, engineering or related field (advanced degree preferred)
    • A minimum year s 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
    ,

Keyskills :
sapenvironmentdeliverycustomer relationssalesdelivery of projectsuser acceptance testingdata qualitydata mappingdata analysislife sciences

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