Veeva Vault RIM - Regulatory Business Analyst

Stark Pharma Solutions Inc; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking a Regulatory Business Analyst with strong Veeva Vault RIM expertise to support regulatory operations, data remediation, system enhancements, and digital transformation initiatives in a remote 6-month contract.

The ideal candidate has 5+ years in Regulatory Affairs systems, hands-on Veeva Vault RIM experience, and knowledge of IDMP/eCTD processes. Collaboration with cross-functional teams is essential.

Qualifications

• Bachelor's degree in Life Sciences, Information Systems, or a related field.
• 5+ years of experience as a Business Analyst supporting Regulatory Affairs systems.
• Hands-on experience with Veeva Vault RIM (configuration, data model, and business process support).
• Experience with data remediation, IDMP, eCTD, and SDLC.
• Knowledge of Veeva Vault Quality RIM integrations.
• Experience supporting validation activities, including UAT and test script reviews.
• Exposure to AI/GenAI, automation, or digital transformation initiatives.
• Familiarity with eCTD publishing solutions; eCTD 4.0 experience is a plus.

Responsibilities

• Support configuration, maintenance, and business processes within Veeva Vault RIM.
• Perform regulatory data remediation and ensure data quality and integrity.
• Support IDMP, eCTD, and regulatory submission processes.
• Manage integrations between Veeva Vault Quality and Veeva Vault RIM.
• Develop and monitor RIM reports, dashboards, and KPIs.
• Coordinate UAT, review test scripts, and support system validation activities.
• Create and maintain SOPs, training materials, and user documentation.
• Collaborate with cross-functional teams on AI/GenAI, automation, and digital transformation initiatives.
• Support continuous process improvements within regulatory systems.

Skills

Regulatory operations

Business analysis

Data remediation

Digital transformation

Cross-functional collaboration

Education

BSc in Life Sciences

Tools

Veeva Vault RIM

Veeva Vault Quality RIM integrations

eCTD publishing tools

UAT/test tooling

Job description

Position

Regulatory Business Analyst - Veeva Vault RIM

Location

Remote

Duration

6-Month Contract

Experience

5 6 Years

Job Overview

We are seeking a Regulatory Business Analyst with strong expertise in Veeva Vault RIM to support regulatory operations, data remediation, system enhancements, and business process optimization. The ideal candidate will have experience with regulatory information management, validation activities, and digital transformation initiatives within a regulated life sciences environment.

Key Responsibilities

• Support configuration, maintenance, and business processes within Veeva Vault RIM.
• Perform regulatory data remediation and ensure data quality and integrity.
• Support IDMP, eCTD, and regulatory submission processes.
• Manage integrations between Veeva Vault Quality and Veeva Vault RIM.
• Develop and monitor RIM reports, dashboards, and KPIs.
• Coordinate UAT, review test scripts, and support system validation activities.
• Create and maintain SOPs, training materials, and user documentation.
• Collaborate with cross-functional teams on AI/GenAI, automation, and digital transformation initiatives.
• Support continuous process improvements within regulatory systems.

Required Qualifications

• Bachelor's degree in Life Sciences, Information Systems, or a related field.
• 5+ years of experience as a Business Analyst supporting Regulatory Affairs systems.
• Strong hands‑on experience with Veeva Vault RIM (configuration, data model, and business process support).
• Experience with data remediation, IDMP, eCTD, and SDLC.
• Knowledge of Veeva Vault Quality RIM integrations.
• Experience supporting validation activities, including UAT and test script reviews.
• Strong documentation skills with experience creating SOPs and training materials.
• Exposure to AI/GenAI, automation, or digital transformation initiatives.
• Familiarity with eCTD publishing solutions; eCTD 4.0 experience is a plus.

Contact

Recruiting Manager
Stark Pharma Solutions Inc
Email: [e-mail]
15 Corporate Place S, Suite 350, Piscataway, New Jersey 08854
www.starkpharma.com