Veeva RIM Consultant / Specialist

REALIGN LLC; West Virginia; Remote; USD 80,000 - 100,000; Full time

Job summary

An innovative firm is on the lookout for a skilled Veeva RIM Consultant/Specialist to enhance regulatory workflows through Veeva Vault RIM solutions. This remote role offers the opportunity to lead the implementation and optimization of regulatory information management systems, ensuring compliance with industry standards. Ideal candidates will have a robust background in regulatory affairs and excellent communication skills to engage with diverse stakeholders. Join a collaborative team that values your expertise and contributes to the vital regulatory processes in the pharmaceutical and life sciences sectors. Elevate your career while making a significant impact in a dynamic environment!

Qualifications

• 3-5 years of experience with Veeva Vault RIM or similar solutions.
• Strong understanding of regulatory affairs and compliance.

Responsibilities

• Lead implementation and optimization of Veeva Vault RIM solutions.
• Analyze and design regulatory workflows for efficiency.

Skills

Veeva Vault RIM

Regulatory Affairs Processes

XML

API Integrations

SQL

Communication Skills

Problem-Solving Skills

Job description

Remote, Ohio 43002 Posted February 4th, 2025

Job Title: Veeva RIM Consultant / Specialist

Location: Remote
Job Type: Contract

Job Summary:

We are seeking an experienced Veeva RIM Consultant / Specialist to join our team. The ideal candidate will have strong expertise in implementing and supporting Veeva Vault RIM solutions within the regulatory space. This role requires a combination of technical knowledge, business process understanding, and excellent communication skills to collaborate with stakeholders across departments to optimize regulatory workflows.

Key Responsibilities:

• Implementation & Configuration:
  • Lead the implementation, configuration, and optimization of Veeva Vault RIM solutions.
  • Collaborate with cross-functional teams to understand regulatory processes and ensure Veeva RIM solutions are tailored to meet business needs.
  • Configure Veeva Vault for regulatory submission management, tracking, and document control.
• System Maintenance & Support:
  • Provide ongoing system support and maintenance for Veeva Vault RIM, including troubleshooting, upgrades, and patches.
  • Perform system testing, validation, and troubleshooting to ensure the functionality aligns with user requirements.
• Business Process & Workflow Optimization:
  • Analyze and design regulatory workflows, ensuring that processes are optimized for efficiency, compliance, and risk management.
  • Ensure integration of Veeva RIM solutions with other enterprise systems (e.g., ERP, DMS, etc.).
• Training & Documentation:
  • Develop user training materials and conduct training sessions for end-users on how to leverage Veeva Vault RIM solutions.
  • Create and maintain system documentation, including user manuals, process flows, and technical specifications.
• Regulatory Compliance:
  • Ensure Veeva Vault RIM solutions adhere to industry regulations, such as GxP, 21 CFR Part 11, EU Annex 11, and other applicable standards.
  • Work closely with regulatory affairs and compliance teams to ensure data integrity and compliance in regulatory submission processes.
• Collaboration & Stakeholder Engagement:
  • Engage with internal and external stakeholders, including IT, regulatory affairs, and business users, to gather requirements and drive solutions.
  • Act as a subject matter expert (SME) on Veeva RIM and provide guidance on best practices and industry standards.

Required Skills & Qualifications:

• Experience:
  • Minimum 3-5 years of hands-on experience with Veeva Vault RIM or similar regulatory information management solutions.
  • Strong understanding of regulatory affairs processes, including document management, submission tracking, and regulatory compliance.
• Technical Skills:
  • Solid experience in configuring, maintaining, and supporting Veeva Vault RIM.
  • Familiarity with Veeva Vault RIM architecture, modules, and integration capabilities.
  • Strong knowledge of XML, API integrations, and SQL for system customization and integration tasks.
• Regulatory Knowledge:
  • Deep understanding of GxP, 21 CFR Part 11, EU Annex 11, and other global regulatory requirements.
  • Experience in regulatory document management and submission processes in the pharmaceutical or life sciences industry.
• Communication & Interpersonal Skills:
  • Strong communication and presentation skills, with the ability to explain complex technical concepts to non-technical stakeholders.
  • Excellent problem-solving skills and the ability to work under pressure in a fast-paced environment.