RIMS Lead/Manager/Analyst

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