Regulatory Business Analyst - Regulatory Technology (Contract)

Vertex Pharmaceuticals LLC; United States; Remoto; USD 103.000 - 113.000; Tempo pieno

Descrizione del lavoro

Vertex Pharmaceuticals LLC is seeking an experienced Regulatory Business Analyst to optimize governance of regulatory data using Veeva Vault RIM. You will translate business needs into system enhancements, support integrations with Vault modules, and drive user acceptance testing and change management across Cross-functional teams.

The role emphasizes data models (IDMP), eCTD-related activities, and analytics to enable regulatory operations improvements.

Competenze

• Translate business requirements into system enhancements for Veeva Vault RIM and related systems.
• Serve as a functional SME for Veeva Vault RIM data model and regulatory structures.
• Support design, enhancements, and optimization including integrations with other Vault apps.
• Apply IDMP data models to support data remediation and accurate regulatory data representation.

Mansioni

• Gather and translate business requirements for regulatory systems.
• Drive UAT, test script reviews, and validation coordination.
• Develop and maintain reports and dashboards across Vault RIM for KPI tracking.
• Partner with stakeholders to prioritize enhancements and optimize processes.
• Create training materials and reference docs to support adoption and change management.
• Communicate effectively with stakeholders at all levels and drive initiatives forward.

Conoscenze

Veeva Vault RIM

Regulatory data

Business process

Requirements gathering

System integrations

UAT coordination

Change management

Dashboards & analytics

Cross-functional collaboration

AI & automation

IDMP data models

Formazione

B.S. degree or equivalent

Strumenti

Veeva Vault RIM

Descrizione del lavoro

Job Description

We are looking for an experienced Regulatory Business Analyst with strong expertise in Veeva Vault RIM, regulatory data management, and business process optimization to support Global Regulatory Affairs technology initiatives. The ideal candidate will have experience gathering and translating business requirements, supporting system enhancements and integrations, driving user acceptance testing and change management activities, and partnering with cross-functional stakeholders to improve regulatory operations. Experience with Veeva Vault RIM data models, IDMP/PMS standards, eCTD publishing, reporting and analytics, and emerging technologies such as AI and automation is highly desirable. The successful candidate will be a proactive, self-directed professional who can independently drive initiatives while serving as a trusted partner between Regulatory Affairs and technical teams.

Required Knowledge & Skills

• Elicit, document, and translate business requirements into system enhancements for Veeva Vault RIM, and other systems, working closely with regulatory stakeholders, superusers, and IT teams.
• Serve as a functional SME for Veeva Vault RIM, with strong understanding of the data model, including registration objects and core regulatory data structures.
• Support design, enhancement, and ongoing optimization of Veeva Vault RIM, including integrations with Veeva Quality, Clinical, and PromoMats.
• Apply working knowledge of IDMP data models (including PMS) to support data remediation efforts and ensure accurate representation of regulatory data within Vault RIM.
• Configure and support key RIM capabilities, including Global Content Plans, Active Dossier setup, and dossier management across Modules 2–5.
• Partner with technical teams to support system design, validation, data migration, data cleansing, and UAT activities, including test script review.
• Develop and maintain reports and dashboards across Vault RIM objects to enable KPI tracking, data monitoring, and informed business decision-making.
• Collaborate cross-functionally to prioritize enhancements, drive process optimization, and ensure alignment between business needs and system capabilities.
• Support user education and change management, including development of training materials, business guidelines, and reference documentation.
• Communicate effectively with stakeholders at all levels; work independently and proactively to drive initiatives forward.
• Contribute to broader regulatory technology strategy, including adoption of modernization approaches (e.g., AI-enabled authoring tools, labeling/CMC modernization, ICH M4Q(R2), FHIR-based standards).
• Support capabilities related to eCTD submissions, including experience with or exposure to eCTD 4.0 within Vault RIM environments (preferred).

Required Experience & Education

• B.S. degree (or equivalent experience) with 5+ years of experience in regulatory operations, regulatory technology, or business analysis.
• Proven experience with Veeva Vault RIM including configuration, data model understanding, and business process support.
• Experience with regulatory data standards (e.g., IDMP/PMS) and their application in system implementations or data remediation efforts.
• Experience with system integrations within the Veeva ecosystem (e.g., RIM–Quality).
• Hands-on experience with requirements gathering, documentation, and translation into system enhancements.
• Experience supporting validation processes, including UAT coordination, test script review.
• Experience creating training materials, SOPs, and user documentation, and supporting adoption of new capabilities post-go-live.
• Experience with reporting and analytics within enterprise systems to support KPIs and operational metrics.
• Familiarity with eCTD publishing solutions; exposure to eCTD 4.0 is a plus.
• Exposure to AI/GenAI tools, automation, or digital transformation initiatives in regulatory or content processes is a plus.

Contract Length:

6 months with the chance to extend.

Pay Range

75/hr. - 82/hr.

Shift/Hours

Monday - Friday; Remote