RIMS Manager

Responsibilities:

Supports delivery of projects involving implementation and/or management of Regulatory Information

Supports 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.

Support data transformation & enrichment activities.

Document E2E Migration Strategy and associated documentation.

Supports implementation of new RIMS platform including RegulatoryOne and QualityOne:

business requirements elicitation

business analysis supporting collection, documentation, and harmonization of functional requirements 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 continuous improvement of existing RegOne and QualityOne platforms.

Data Harmonization, Implementation of data standards

Data Quality Framework to identify & address data quality issues.

Supports data alignment between RIMS and other systems (Clinical, Supply Chain, etc.)

Working with product roadmap to ensure changing requirements are addressed.

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.

Experience:

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

A minimum 8 year's relevant experience in the field of Regulatory Information Management within the Consumer Goods Industry

Expertise with Regulatory Information Management Processes

with particular focus on Registrations Data Management

5+ years supporting implementation & maintenance of Regulatory Information Management Systems

3+ years supporting data migration, data assessment, data enrichment, data transformation and data readiness in the context of Regulatory Information Management System

Experience supporting implementation & maintenance of data standards within RIMS

naming convention, reference data standards, master data standards.

Good understanding & experience with Veeva RegOne, data model and processes

Experience with multiple RIMS platforms is an advantage: Veeva, Generis, Liquent Insight, Aris Global's LifeSphere, Amplexor

Effective communication, presentation and interpersonal skills, ability to collaborate and engage effectively with the entire eco system (customer, vendor)

Ability to lead a small team of colleagues to deliver on business commitments and project timelines.

Expert on life sciences compliance and computer systems validation requirements.

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