Greetings!!!
Welcome to TechProjects. We specialize in IT system integration, supporting major public sector clients across New York State. Our focus is on delivering high-quality technology solutions while creating strong career opportunities for our employees.
We are currently hiring and looking for talented tech professionals who are eager to work on impactful and innovative projects. We offer competitive compensation, excellent benefits, and opportunities for professional growth.
We look forward to connecting with you and exploring how you can be a part of our team.
Job Title: RIMS Lead / Manager / Analyst Location: Remote Duration: Long term
Description of Role and 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:
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 project delivery teams:
Ensuring project team is onboard and aligned to the project expectations
Ensuring business requirements are defined with precision & quality, driving execution and delivery
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
Required Skills:
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.
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
Effective communication, presentation and interpersonal skills, ability to collaborate and engage effectively with the entire eco system (customer, vendor)
Expert on life sciences compliance and computer systems validation requirements
Ability to drive adoption of new RIMS platform within business community
Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines