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Job Title: Senior Manager, Regulatory Information Management
Job Location: Remote
Job Duration: Long-Term

Job Description:

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:

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
Identify, lead and execute data transformation & enrichment activities
Document E2E Migration Strategy and associated documentation
Drives implementation of new RIMS platform:
Business requirements elicitation providing subject matter expertise to drive harmonized functional requirements strategy 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 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:

Data Harmonization, Implementation of data standards
Data Quality Framework to identify & address data quality issues
Identify and support implementation of automation opportunities, such as leveraging Robotic Process Automation, Artificial Intelligence
Drives data alignment between RIMS and other systems (Clinical, Supply Chain, etc.)
Working with product roadmap to ensure changing requirements are addressed

Leads offshore project delivery teams:

Ensuring project team is onboard and aligned to the project expectations
Ensuring business requirements are defined with precision & quality, driving execution in partnership with offshore delivery lead when applicable
Create a motivating & inspiring environment, foster innovation, ideas and quality
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

Minimum Qualifications

Bachelor's degree required in science, engineering or related field (advanced degree preferred)
Preferred experience and skills
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

Apptad Inc

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