Veeva RIM Consultant

at  Capgemini

JOB DESCRIPTION:

We are seeking a highly skilled Veeva RIM Consultant to 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.

JOB REQUIREMENTS:

• Strong understanding of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM.
• 5+ years of experience in Veeva RIM Submissions and submissions archive, Registrations and Publishing.
• 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.
• Strong communication and interpersonal skills, with the ability to work collaboratively across teams.

• 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.
• Regulatory Information Management:
  o Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM.
  o Ensure that regulatory submissions comply with applicable local and international regulations and guidelines.

o Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents.

• System Configuration and Maintenance:

o Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows.

o Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution.

• Data Management:

o Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones.

o Implement data governance practices to maintain compliance and quality of regulatory data.

• Cross-Functional Collaboration:

o Collaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions.

o Act as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities.

• Process Improvement:

o Identify opportunities for process enhancements and automation within the regulatory submission process.

o Develop and implement standard operating procedures (SOPs) for the use of Veeva Vault RIM.

• Regulatory Compliance:

o Stay updated on regulatory changes and ensure that the organization’s processes and systems comply with current regulations and industry best practices.
o Participate in audits and inspections as necessary, providing documentation and system access as required.