Manager Regulatory Information
Year Mumbai, Maharashtra, India
Job Description
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! We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We?re 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?re 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 - RIM Lead
Within our Global Regulatory Affairs business, we are excited & committed to build an industry leading Regulatory Information Management & Governance capability to help our clients deliver medicines faster to patients. With the sky as the limit, we are passionate, resilient, and relentless in our pursuit.
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
- 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 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 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 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 project delivery teams:
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 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
- 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
Minimum Qualifications
- Bachelor's degree required in science, engineering or related field (advanced degree preferred)
- 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
- 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
- Experience with Document Management systems ? Documentum, First Doc, etc.
- 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 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
JobManager Primary LocationIndia-Mumbai ScheduleFull-time Education LevelBachelor's / Graduation / Equivalent Job PostingMay 10, 2023, 6:10:26 AM Unposting DateOngoing Master Skills ListOperations Job CategoryFull Time
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Job Detail
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Job IdJD3070747
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMumbai, Maharashtra, India
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EducationNot mentioned
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ExperienceYear