W2 only - Not available for C2C / 1099 consulting
PLEASE NOTE - Short-term contract (4 months)
Start Date : ASAP
Position Overview
The Regulatory Information Management (RIM) Consultant is responsible for supporting the Regulatory Affairs Department, and leading the electronic management and storage of critical Regulatory submissions, documents, and correspondence.
This position involves understanding / ensuring adherence to applicable regulatory requirements, internal and external stakeholder collaboration.
This position will report into the Regulatory Project Management function and requires experience with Electronic Document Management System (EDMS), Regulatory Information Management (RIM) system, Regulatory publishing activities, and IT systems.
Job Functions / Responsibilities :
- Serve as Business Owner for Veeva Vault RIM system
- Manage logistics / archival related to global Health Authority submissions
- Serve as RA Lead for key collaborations with publishing and other Regulatory Systems vendors, as needed
- Partner with colleagues in IT, Regulatory, and QA to process system enhancements / change controls.
- Ensure processes are in place for system maintenance & operation
- Oversee & control the life cycle of Regulatory IT systems, as assigned
- Provide user training & user support to use systems efficiently
- Ensure continued & improved overall user satisfaction with systems
Qualifications :
- Bachelor’s Degree in a scientific discipline or equivalent experience
- 5-10 years of experience in the pharmaceutical industry, including 3-5 years in Regulatory Affairs
- Experience managing Veeva RIM and EDMS required
- Knowledge and demonstrated experience in relevant US / EU / ICH Regulations (e.g., eCTD format, GxP regulations), Regulatory publishing tools, and IT / EDMS systems (e.
g., maintenance and / or implementation)
- Experience in 21 CFR Part 11 compliance / other electronic registration systems requirements
- Experience in supporting & troubleshooting regulatory systems
- Experience working with managed services and / or offshore teams
Knowledge, Skills, & Abilities :
- Strong verbal and written communication
- Demonstrated ability to lead internal / external collaborations
- xEVMPD data submission experience is highly desired
- Experience with Veeva Vault Connectors is preferred
Consultant, Regulatory Information Management (RIM)
The Regulatory Information Management (RIM) Consultant is responsible for supporting the Regulatory Affairs Department, and leading the electronic management and storage of critical Regulatory submissions, documents, and correspondence. This position will report into the Regulatory Project Managemen...
Road & Bridge Program Manager
Performs skilled administrative work, planning, implementing, and directing complex projects and services provided by the County's Road & Bridge Program, which includes the Maintenance, Construction, Landscape, and Heavy Equipment Fleet divisions. ...
Project Architect | Project Manager - Federal
Project Architect | Project Manager. May develop project fee proposals, Project Management plans, and execute Design Quality Control plans. The project focus will be Dept. Develops design and construction documents, facilitates charrettes, develops studies and reports, field assessments, and other d...
Regulatory Affairs Manager
A company is looking for a Regulatory Manager to join their Corporate Counsel team. ...
Regulatory Affairs Specialist III
The primary purpose of this position is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant US, EU, ISO standards and other regulator...
Analyst, Data Insights - Lunar Production Operations
As a Data Insights Analyst, you are responsible for building data models, crafting intuitive visuals, and providing analysis that helps Blue Origin build a road to the Moon. Energized by helping solve stakeholder needs through data. Work closely with program and operations stakeholders to provide da...
Compliance and Operational Risk Testing Analyst Senior
We are seeking a dedicated Enterprise Compliance and Operational Risk Testing Analyst Senior-CFO to work a hybrid schedule from one of our regional offices. The enterprise Compliance and Operational Risk Testing (ECORT) Analyst Senior supports the Second Line of Defense's oversight of the Chief Fina...
Operations Business Analyst (Salesforce)
JOB DESCRIPTION:</strong></p> <ul> <li>The Operations Business Analyst role helps deliver business focused Salesforce. The Operations Business Analyst will elicit business requirements and translate them into information the project team can use to design and develop process ...
Compliance Manager, Senior
Prepares internal compliance communications covering compliance issues and regulatory developments (compliance summaries, white papers, monthly reports, etc. The FIS Global Regulatory Compliance Team is part of FIS’ Legal, Compliance and Corporate Affairs (LCCA) organization. Performs pe...
Remote Retirement Plan Compliance Analyst
Ability to successfully complete and support the work outlined for the Compliance Associate roles. Reads and comprehends retirement plan provisions from plan documents, summaries of plan provisions, and related plan materials to ensure accuracy and compliance with regulations. Supports the Plan Cons...