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Manager-RA

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.
We are Genpact. Transformation happens here. Come, be a part of our exciting journey! 
Transformation happens here. Come, be a part of our exciting journey!
Inviting applications for the role of Regulatory Information Management – Manager - English!
Responsibilities
•    Provides expertise and leads the delivery of projects involving implementation and/or management of Regulatory Information 
•    Drives Data & Content Migration into Regulatory Information Management System involves:
o    Source to target data model mapping 
o    Data quality assessment
o    Recommend / identify / facilitate agreeing on data standards for new RIMS and data migration – naming convention, reference data standards, master data standards
o    Identify, lead and execute data transformation & enrichment activities
o    Document E2E Migration Strategy and associated documentation
•    Drives implementation of new RIMS platform:
o    business requirements elicitation – providing subject matter expertise to drive harmonized functional requirements strategy with SMEs and stakeholders
o    working with the implementation team to ensure the requirements are adequately implemented
o    supports SMEs & stakeholders with functional & user acceptance testing
o    supports change management – stakeholder engagement plan, communication plan, and roll out of new RIMS platform and continuous adoption within the business user community
•    Drives continuous improvement of existing RIMS platform:
o    Data Harmonization, Implementation of data standards
o    Data Quality Framework to identify & address data quality issues
o    Identify and support implementation of automation opportunities, such as leveraging Robotic Process Automation, Artificial Intelligence
o    Drives data alignment between RIMS and other systems (Clinical, Supply Chain, etc.)
o    Working with product roadmap to ensure changing requirements are addressed
•    Leads offshore project delivery teams:
o    Ensuring the project team is on board and aligned to the project expectations
o    Ensuring business requirements are defined with precision & quality, driving execution in partnership with offshore delivery lead when applicable
o    Create a motivating & inspiring environment, foster innovation, ideas and quality
•    Supports IDMP implementation
o    Understanding of EU Implementation Guide, mapping to sources (M3, SMPC, eAF, RIMS, others)
o    Identifying data transformation and correction needs for IDMP readiness
o    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!
Minimum qualifications
•    Relevant experience in the field of Regulatory Information Management within the Pharmaceutical Industry
•    Expertise with Regulatory Information Management Processes – Registrations Data Management, Submission Planning, Submission Content Planning, Content Management, Submissions Publishing, Labeling Management
•    Supporting implementation & maintenance of Regulatory Information Management Systems
•    Supporting data migration, data assessment, data enrichment, data transformation and data readiness in the context of Regulatory Information Management System
•    Reasonable understanding of Regulatory business processes – Marketing Authorization Applications, License Renewals, Variations, Labeling Submissions
•    Experience defining & implementing 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’s LifeSphere, Amplexor
•    Experience with Document Management systems – Documentum, FirstDoc, etc.
•    Experience with analyzing regulatory information, designing and developing reports, visualizations on BI platforms such as Spotfire, Power BI, Qlik Sense, etc. 
•    Knowledge of ISO IDMP Standards, SPOR & EU Implementation Guide, xEVMPD, PQCMC is an advantage 
•    Ability to drive adoption of new RIMS platform within business community
•    Effective communication, presentation and interpersonal skills, ability to collaborate and engage effectively with the entire eco system (customer, vendor, Genpact)
•    Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines
•    Expert on life sciences compliance and computer systems validation requirements
Preferred qualifications
•    Bachelor's degree required in science, engineering or related field (advanced degree preferred)

 What we can offer! 

•    Attractive salary; 
•    Stable job offers - employment contract 
•    Work in a multicultural and diverse environment with employees from over 30 countries 
•    Genpact supports langauge courses, professional tranings and great career development opportunities 
•    Free access to our award-winning learning platform 

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: Manager

Job ID: LIF007107

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Mar 22, 2022

Master Skills List: Operations

Job Category: Full Time