Veeva RIM Consultant

Stanley David and Associates; United States; Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Stanley David and Associates is seeking an experienced Veeva RIM Consultant to lead regulatory information management initiatives in the pharmaceutical and life sciences space. You will implement and support Veeva Vault RIM, collaborate with regulatory affairs, quality, and IT, and drive submission tracking while ensuring FDA/ICH and GxP compliance and data integrity.

The role includes gathering requirements, configuring workflows, testing, validating releases, and preparing specifications,

Qualifikationen

• Hands-on Veeva Vault RIM implementation, configuration, or support.
• Strong understanding of regulatory affairs and RIM processes.
• Experience with regulatory submissions, product registrations, and submission tracking.
• Familiarity with GxP, data integrity, change control, and CSV where applicable.
• Excellent communication and stakeholder management skills.

Aufgaben

• Implement, configure, maintain, and support Veeva Vault RIM applications.
• Collaborate with regulatory teams to manage regulatory information and submissions.
• Support RIM modules such as Registrations, Submissions, Submissions Archive, and Regulatory Operations.
• Gather requirements, perform gap analyses, and translate needs into solutions.
• Configure workflows, metadata, reports, dashboards, and user permissions.
• Track submission milestones and maintain submission records.
• Coordinate with regulatory affairs, quality, IT, analysts, developers, and validation teams.
• Perform functional, integration, UAT testing; resolve defects and validate releases.
• Support data migration, cleansing, mapping, and legacy system integration.
• Ensure compliance with FDA, ICH, and GxP requirements.
• Prepare functional specs, configuration docs, SOPs, and training materials.
• Troubleshoot issues and provide ongoing production support.

Kenntnisse

Veeva Vault RIM

Regulatory Affairs

Regulatory submissions

GxP & data integrity

Requirements gathering

Business process mapping

Testing & validation

Stakeholder management

Documentation & training

Jobbeschreibung

We are seeking an experienced Veeva RIM Consultant with expertise in Regulatory Information Management (RIM) within the pharmaceutical or life sciences industry. The ideal candidate will have hands-on experience implementing, configuring, supporting, or enhancing Veeva Vault RIM applications and managing regulatory data and submissions in compliance with applicable regulatory requirements.

Key Responsibilities

• Implement, configure, maintain, and support Veeva Vault RIM applications.
• Work with regulatory affairs teams to manage regulatory information, product registrations, submission content, and regulatory activities.
• Support Veeva RIM modules such as Registrations, Submissions, Submissions Archive, and Regulatory Operations, depending on project scope.
• Gather business requirements, conduct gap analysis, and translate regulatory business needs into functional and technical solutions.
• Configure application workflows, document lifecycles, metadata, fields, reports, dashboards, and user permissions.
• Support regulatory submission processes, including tracking submission milestones, managing documents, and maintaining submission records.
• Collaborate with regulatory affairs, quality, IT, business analysts, developers, and validation teams.
• Perform functional testing, integration testing, UAT, defect resolution, and release validation.
• Support data migration, data cleansing, data mapping, and legacy system integration activities.
• Ensure adherence to applicable regulatory requirements, including FDA regulations, ICH guidelines, and GxP requirements where applicable.
• Prepare and maintain functional specifications, configuration documents, test scripts, SOPs, and training materials.
• Troubleshoot application issues and provide ongoing production support.

Required Skills

• Hands-on experience with Veeva Vault RIM implementation, configuration, or support.
• Strong understanding of Regulatory Affairs and Regulatory Information Management processes.
• Experience with regulatory submissions, product registrations, regulatory activities, and submission tracking.
• Knowledge of pharmaceutical product lifecycle management and global regulatory requirements.
• Experience with requirements gathering, business process mapping, testing, and documentation.
• Familiarity with GxP, data integrity, change control, and computer system validation, where applicable.
• Strong communication, analytical, and stakeholder management skills.

Preferred Qualifications

• Experience with Veeva Vault configuration and administration.
• Knowledge of regulatory submission standards such as eCTD and applicable regional requirements.
• Experience integrating Veeva RIM with other enterprise systems.
• Veeva certifications or relevant implementation experience.
• Experience working with pharmaceutical, biotechnology, or medical device organizations.