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Company

Capgemini Engineering · 6 hours ago

Veeva RIM Consultant

Massachusetts, United States

Full-time

Remote

Senior Level

5+ years exp

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ConsultingInformation Services

Actively Hiring

No H1B

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Responsibilities

Assist the sales team with pre-sales technical knowledge and presentations.

Understand customer requirements and provide sales support.

Conduct product demonstrations, both online and face-to-face.

Identify and understand the specific needs of clients.

Design and develop tailored solutions that meet client requirements.

Prepare and present proposals to clients.

Respond to technical and functional product queries during the sales process.

Work closely with the sales team and other departments to ensure coordination and smooth execution of sales processes.

Train the sales team on the technical aspects of the product or service.

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.

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.

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.

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.

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.

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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Veeva Vault RIMRegulatory submissionsVeeva Vault admin certificationVeeva RIM Connectors