23 Oct
|
Cygnus Professionals
|
India
23 Oct
Cygnus Professionals
India
Job Overview We are looking for an experienced Veeva Vault RIM Specialist with strong functional and hands-on configuration expertise in Veeva Vault Regulatory Information Management (RIM), particularly in Submission Content Plans (SCP). The ideal candidate will be responsible for optimizing Submission Content Plan configurations, managing regulatory submission workflows, implementing changes, and supporting business stakeholders across regulatory operations. This role requires practical Vault administration and configuration experience, end-to-end change management capabilities, and a good understanding of pharmaceutical and medical device regulatory submissions. Candidates with only theoretical knowledge or business-level understanding of Veeva RIM, without hands-on configuration experience, will not be suitable for this position.
Key Responsibilities
• Configure, maintain, and optimize Veeva Vault RIM Submission Content Plans based on regulatory and business requirements.
• Analyze existing SCP setups and identify opportunities to improve submission planning, content organization, and workflow efficiency.
• Perform hands-on Vault configuration and administration, including relevant objects, fields, workflows, lifecycle settings, action triggers, entry actions, and validation criteria.
• Gather and analyze business requirements from clients and regulatory stakeholders and translate them into functional and technical configuration solutions.
• Manage change requests from requirement gathering through impact assessment, configuration, testing, implementation, and post-deployment validation.
• Lead end-to-end change management activities, including documentation, stakeholder communication, testing coordination, and release support.
• Support User Acceptance Testing (UAT),
defect investigation, resolution, and validation of configuration changes.
• Provide functional support for Veeva Vault RIM, including troubleshooting issues related to Submission Content Plans and regulatory processes.
• Demonstrate knowledge of medical device regulatory submissions, including Premarket Approval (PMA) and 510(k) submissions, as applicable.
• Work closely with clients and cross-functional teams to ensure solutions meet regulatory, business, and operational requirements.
• Maintain configuration documentation, change records, test evidence, and relevant process documentation. Required Skills and
Qualifications:
• Solid functional knowledge of Veeva Vault RIM and regulatory information management processes.
• Good understanding of Submission Content Plans, their structure, setup, configuration, and business usage.
• Proven hands-on experience configuring and administering Veeva Vault, rather than business-process knowledge alone.
• Practical understanding of Vault configuration components, including:
• Objects, fields, and layouts
• Workflows and lifecycle configuration
• Entry actions and action triggers
• Validation rules and validation criteria
• Submission Content Plan configuration and optimization
• Demonstrated experience managing changes end to end, from requirement gathering to implementation and validation.
• Experience with UAT planning, execution, defect tracking, and resolution.
• Knowledge of medical device regulatory submission types, including PMA and 510(k), and their associated content and documentation requirements.
• Strong client-facing communication, requirement-gathering, and stakeholder-management skills.
• Ability to troubleshoot configuration issues and independently implement approved changes.
📌 Veeva Vault RIM Specialist – Submission Content Plans (India)
🏢 Cygnus Professionals
📍 India