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RIMS Manager

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

Connecticut (USA), Illinois (USA)

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

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.