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IT Veeva Vault RIM Configuration Specialist
3 months ago
As an IT Configuration Specialist, you’ll play a crucial role in managing and optimizing the IT systems within the IT Regulatory Affairs Department. Your responsibilities will include designing, implementing, and maintaining IT systems, interfaces, and applications. Let’s break down the key aspects of this role:
Responsibilities:
1. Subject Matter Expertise:
o Act as a subject matter expert for the Veeva RIM suite, which
includes Registrations, Submissions Documents, and Submissions Archive.
o Contribute to projects and implement changes related to Veeva Vault RIM.
o Configure Veeva Vault RIM in accordance with Pharma computer system validation
procedures, including the security profiles.
o Manage the 3 annual releases: environment, release notes and impact assessment,
related tests.
o Solve any related issues that arise.
2. Project Support:
o Provide support for projects, interfaces, and reports as approved and assigned.
o Tasks may include documentation, installation, qualification, testing, and release
activities.
3. Improvements and Innovations on our roadmap (not exhaustive & to be prioritized):
o Collaborate with stakeholders to improve user information interfaces.
o Adopt the new Azure Active Directory for authentication and user provisioning.
o Implement IDMP (Identification of Medicinal Products) requirements.
o Enhance the submissions content plan.
o Automate submissions archives.
o Implement cross-links and a QMS-to-RIM connector.
o Explore Data Quality Control using new artificial intelligence technologies.
4. Qualification Activities:
o Assist with qualification activities by writing and executing assigned installation and
operational qualification scripts, in collaboration with IT compliance services.
5. Configuration Management:
o Implement configuration changes as per approval.
o Maintain, update, and document IT infrastructure configurations and changes.
6. Incident Support:
o Contribute to third-level support for incident and service request management.
o Ensure qualitative and timely resolution of incidents.
7. Collaboration:
o Work closely with a global team of Regulatory Affairs and IT colleagues, including
managed services.
o Work with a team of Veeva Vault specialists and in close collaboration with the IT
Regulatory system owner.
8. Learning Opportunities:
o Seize the opportunity to learn new technical skills in a dynamic environment.
9. Global User Base:
o Provide support to a global user base, ensuring smooth IT operations.
Requirements
Qualifications:
• Bachelor’s degree in Computer Science, Information Technology, or a related field.
• Relevant technical certifications or experience.
• Experience working in IT, preferably as a systems administrator
• Familiarity with various operating systems, databases, and programming languages.
•Key Skills for IT Configuration Specialist
Technical Skills:
1. Autonomous and Self-Motivated:
o Demonstrate a proactive approach to work.
o Maintain a strong sense of urgency in resolving issues and meeting deadlines.
2. Veeva Vault Administration:
o Possess strong technical expertise with Veeva Vault.
o Ideally, hold a Veeva Vault Admin Certification.
3. Adaptability and Learning Attitude:
o Approach work assignments with flexibility and a willingness to learn.
o Embrace new technologies and stay updated on industry trends.
4. System Administration Experience:
o Worked with both Cloud (SaaS) and on-premises applications.
o Familiarity with system administration tasks, including user management, security, and configuration.
5. Technological Acumen:
o Proficient in REST API usage and application integration technologies.
o Knowledge of Document Management Systems, including Veeva Vault RIM and Lorenz
DocuBridge (a plus).
6. Database Proficiency:
o Skilled in working with common database technologies, such as Oracle and MSSQL.
7. Regulatory Experience:
o Minimum 3 years of experience in Regulatory Affairs or eCTD Submission Publishing.
o Familiarity with regulatory processes and requirements.
8. Computer Systems Validation (CSV):
o Understanding of CSV principles and experience with validation activities.
9. Additional Tools:
o Exposure to tools like DocXtools, DXC Toolbox, PleaseReview, and StartingPoint is
advantageous.
Soft Skills:
1. Openness and Adaptability:
o Willingness to take on support responsibilities for other systems as needed.
o Adapt to changing priorities and tasks.
2. Effective Communication:
o Excellent command of the English language (both verbal and written).
o Strong communication skills when collaborating with colleagues, other IT areas, and
vendors.
3. Team Player:
o Collaborate effectively within cross-functional teams.
o Foster a positive team environment.
4. Attention to Detail:
o Maintain a focus on quality and accuracy in all tasks.
o Pay attention to the finer points of system configuration and management.
