Job Description

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We&rsquore harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we&rsquore calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. Welcome to the relentless pursuit of better. Inviting applications for the role of Manager, Regulatory Information Management We are now inviting applications for the role of Manager, Regulatory Information Management -. As an expert 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 quality assessment . Recommend / identify / facilitate agreeing on data standards for new RIMS and data migration - naming convention, reference data standards, master data standards . Support data transformation & enrichment activities . Document E2E Migration Strategy and associated documentation Supports implementation of new RIMS platform: . business requirements elicitation - business analysis supporting collection, documentation and harmonization of functional requirements with SMEs and stakeholders . working with the implementation team to ensure the requirements are adequately implemented . supports SMEs & stakeholders with functional & user acceptance testing Supports continuous improvement of existing RIMS platform: . Data Harmonization, Implementation of data standards . Data Quality Framework to identify & address data quality issues . Supports data alignment between RIMS and other systems (Clinical, Supply Chain, etc.) . Working with product roadmap to ensure changing requirements are addressed Supports IDMP implementation . Understanding of EU Implementation Guide, mapping to sources (M3, SMPC, eAF, RIMS, others) . Identifying data transformation and correction needs for IDMP readiness . Supports data readiness, business process readiness 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! . Relevant years of experience in the field of Regulatory Information Management within the Pharmaceutical Industry . Expertise with Regulatory Information Management Processes - with particular focus on Registrations Data Management . Experience supporting implementation & maintenance of data standards within RIMS - naming convention, reference data standards, master data standards . Good understanding & experience with Veeva RIMS, data model and processes . Experience with multiple RIMS platforms is an advantage: Veeva, Generis, Liquent Insight, Aris Global&rsquos 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) . Ability to lead a small team of colleagues to deliver on business commitments and project timelines . Expert on life sciences compliance and computer systems validation requirements Required Education Bachelor\'s degree required in science, engineering or related field (advanced degree preferred) 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.

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