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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.
Inviting applications for the role of Manager, Regulatory Information Management – IDMP Lead.
. As an expert in regulatory information management & IDMP, you will have the opportunity to be a part of a passionate group and help our esteemed clients achieve data drive transformation.
Responsibilities
·    Provide subject matter expertise on ISO IDMP Standards, EU Implementation Guide and SPOR 
·    Drive end to end IDMP data preparation & readiness: data assessment at source, data remediation, data transformation, data enrichment and data completeness
·    Drives design & implementation of IDMP data & business processes
·    With good understanding of regulatory information management & associated business processes, provides expertise in managing IDMP data & processes in a global RIMS platform
·    Leads project delivery teams:
o    Ensuring project team is onboard and aligned to the project expectations
o    Ensuring business requirements are defined with precision & quality, driving execution and delivery 
o    Create a motivating & inspiring environment, foster innovation, ideas and quality
·    Contributes to business develop and growth strategy
·    Lead/Contribute to implementation of Regulatory Information Management system / platform and associated data processes & data operations
·    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
•    Relevant experience in the field of Regulatory Information Management within the Pharmaceutical Industry
•    Expertise and working knowledge with ISO IDMP Standards, EU Implementation Guide, SPOR implementation, xEVMPD
•    Experience with IDMP data assessment, data enrichment, data transformation and data readiness
•    Good understanding of Regulatory Data Standards – Master data, Product Lifecycle Information, Reference Data, Registration Data
•    Reasonable understanding of RIMS functional processes – Registration Management, Submission Planning & Management, Content Management
•    Reasonable understanding of Regulatory business processes – Marketing Authorization Applications, License Renewals, Variations, Labeling Submissions
•    Nice to have: Experience with implementation of Regulatory Information Management systems
•    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

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: LIF007108

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Mar 22, 2022

Master Skills List: Operations

Job Category: Full Time