Veeva RIM Consultant
Posted 1 day ago by 1765965941
Negotiable
Outside
Remote
USA
Summary: The Veeva RIM Consultant role requires a professional with 8-9 years of experience in the IT industry, specifically in regulatory affairs and Veeva RIM. The consultant will manage regulatory submissions, maintain compliance documentation, and collaborate with cross-functional teams to ensure adherence to regulations. A strong understanding of Veeva solutions and regulatory processes is essential for optimizing the regulatory information management processes. The position is remote and classified as outside IR35.
Key Responsibilities:
- Manage the lifecycle of regulatory submissions, including preparation, tracking, and filing of documents in Veeva Vault RIM.
- Ensure compliance of regulatory submissions with local and international regulations and guidelines.
- Maintain and update regulatory documentation, including registration dossiers and compliance documents.
- Configure and customize Veeva Vault RIM to meet organizational needs.
- Monitor system performance, troubleshoot issues, and coordinate with Veeva support.
- Ensure integrity and accuracy of regulatory data within Veeva Vault.
- Implement data governance practices for compliance and quality of regulatory data.
- Collaborate with teams such as Regulatory Affairs and Quality Assurance for timely submissions.
- Act as a point of contact for regulatory queries and provide training on Veeva RIM functionalities.
- Identify opportunities for process enhancements and automation.
- Develop and implement standard operating procedures (SOPs) for Veeva Vault RIM.
- Stay updated on regulatory changes and ensure compliance with current regulations.
- Participate in audits and inspections, providing necessary documentation.
Key Skills:
- 8-9 years of professional experience in the IT industry and regulatory affairs.
- Experience with Veeva RIM and regulatory information management.
- Strong understanding of regulatory processes (e.g., xEVMPD) and systems (e.g., RIMS, VEEVA).
- Veeva Vault admin certification is required.
- Experience with Veeva RIM Connectors is preferred.
- Excellent analytical and problem-solving skills.
- Good stakeholder management and communication skills.
- Strong service mentality and quick comprehension.
- Ability to work in a virtual and matrix environment.
- Bachelor's degree in Computer Science, Software/Electronics Engineering, Information Systems, or related field.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: IT
Detailed Description From Employer:
Job Title: Veeva RIM Consultant
Location: Remote
Duration: 12+ months
Job Description:
At least 8-9 years of professional experience in the IT industry. Regulatory Affairs Experience in Regulatory information management VEEVA RIM Demonstrated practical working experience in both processes (eg.xEVMPD) and utilizations of regulatory systems (RIMS, VEEVA). Manage and optimize our regulatory information management processes using the Veeva Vault RIM platform. The ideal candidate will have a strong background in regulatory affairs, experience with Veeva solutions, and a deep understanding of compliance requirements within the pharmaceutical or biotechnology industry. This role involves managing regulatory submissions, maintaining regulatory documents, and supporting cross-functional teams to ensure compliance with local and global regulations. Good stakeholder management and communication skills, Strong service mentality Quick comprehension, good analytical and problem-solving skills Ability to work in a virtual and matrix environment.
Key Responsibilities:
Regulatory Information Management:
Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM.
Ensure that regulatory submissions comply with applicable local and international regulations and guidelines.
Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents.
System Configuration and Maintenance:
Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows.
Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution.
Data Management:
Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones.
Implement data governance practices to maintain compliance and quality of regulatory data.
Cross-Functional Collaboration:
Collaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions.
Act as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities.
Process Improvement:
Identify opportunities for process enhancements and automation within the regulatory submission process.
Develop and implement standard operating procedures (SOPs) for the use of Veeva Vault RIM.
Regulatory Compliance:
Stay updated on regulatory changes and ensure that the organization s processes and systems comply with current regulations and industry best practices.
Participate in audits and inspections as necessary, providing documentation and system access as required.
Qualification:
At least 8-9 years of professional experience IT industry Regulatory Affairs Experience in Regulatory information management VEEVA RIM Demonstrated practical working experience in both processes (eg.xEVMPD) and utilisation of regulatory systems (RIMS, VEEVA)
Good understanding of Regulatory Affairs business processes Regulatory Information management VEEVA Vault RIM experience
Good understanding of both processes (eg. xEVMPD) and systems (eg.RIMS, VEEVA) Results-driven and pragmatic approach to work Good organizational skills, self-motivated and proactive Meticulous working style and high attitude to quality
Veeva Vault admin certification is required
Experience with Veeva RIM Connectors is preferred
Good Presentation skills for conducting product demonstrations.
Excellent analytical and problem-solving skills, with attention to detail and accuracy.
Good stakeholder management and communication skills Strong service mentality Quick comprehension, good analytical and problem-solving skills Ability to work in a virtual and matrix environment
Education: At least a bachelor s degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or closely related field is required.