Senior Manager Regulatory Information Management - Remote / Telecommute

We are looking for

• 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.

• 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.
• 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, and 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.