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Lead Consultant - Regulatory Affairs

2.00 to 5.00 Years   Mumbai City   23 Jan, 2023
Genpact India Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaERP / CRM
EmploymentTypeFull-time

Job Description

    Regulatory Information Management Lead Consultant.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. Main Responsibilities include: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 data operations in RIMS platform: o Creation and management of regulatory information during lifecycle management of a medicinal product o Ensuring data quality & standards in the management of regulatory information 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 Your Experience: 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 Required Education Bachelors degree required in science, engineering or related field (advanced degree preferred),

Keyskills :
sapenvironmentdeliverycustomer relationssalesdelivery of projectsdata qualitydata mappingdata analysislife sciencesdata migrationcustomer focus

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