Job Description

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world\xe2\x80\x99s biggest brands\xe2\x80\x94and we have fun doing it. We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are 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 are 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 Senior 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:
Main Responsibilities include:

• Provides expertise and leads 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 and data migration \xe2\x80\x93 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 platform:

o business requirements elicitation \xe2\x80\x93 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 \xe2\x80\x93 stakeholder engagement plan, communication plan, and roll out of new platform and continuous adoption within the business user community

• Drives continuous improvement of existing 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 client and other systems (Clinical, Supply Chain, etc.)
o Working with product roadmap to ensure changing requirements are addressed

• 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

• Supports IDMP implementation

o Understanding of EU Implementation Guide, mapping to sources (M3, SMPC, eAF, others)
o Identifying data transformation and correction needs for readiness
o Supports data readiness, business process readiness

• Communicates & collaborates effectively with different groups both on the business & IT side, including senior stakeholders \xe2\x80\x93 ability to articulate complex scenarios succinctly and targeted to the group
• Ensure customer success throughout the engagement

Qualifications we seek in you!

• A relevant experience in the field of Regulatory Information Management within the Pharmaceutical Industry
• Expertise with Regulatory Information Management Processes \xe2\x80\x93 Registrations Data Management, Submission Planning, Submission Content Planning, Content Management, Submissions Publishing, Labeling Management
• Experience in supporting implementation & maintenance of Regulatory Information Management Systems
• Experience in 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 \xe2\x80\x93 Marketing Authorization Applications, License Renewals, Variations, Labeling Submissions
• Experience defining & implementing data standards within \xe2\x80\x93 naming convention, reference data standards, master data standards
• Good understanding & experience with Veeva RIMS, data model and processes
• Experience with multiple platforms is an advantage
• Experience with Document Management systems \xe2\x80\x93 Documentum, FirstDoc, etc.
• Experience with medical devices or drug/device combination products as it relates to management of data
• Nice to have - Experience with analyzing regulatory information, designing, and developing reports, visualizations on BI platforms such as Spotfire, Power BI, Qlik Sense, etc.
• Good Knowledge of ISO Standards, SPOR & EU Implementation Guide, xEVMPD, PQCMC is an advantage
• Ability to drive adoption of new 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

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.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a \'starter kit,\' paying to apply, or purchasing equipment or training.

Genpact