Capgemini
Veeva RIM Consultant
Capgemini, Boston, Massachusetts, us, 02298
Job Title:
Veeva RIM Consultant Job Location:
Remote
Full Time Employment with Capgemini Engineering
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.
Key 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.
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.
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.
Life at Capgemini: Flexible work Healthcare including dental, vision, mental health, and well-being programs Financial well-being programs such as 401(k) and Employee Share Ownership Plan Paid time off and paid holidays Paid parental leave Family building benefits like adoption assistance, surrogacy, and cryopreservation Social well-being benefits like subsidized back-up child/elder care and tutoring Mentoring, coaching and learning programs Employee Resource Groups Disaster Relief
About Capgemini Engineering: World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse group of 340,000 team members in more than 50 countries. #J-18808-Ljbffr
Veeva RIM Consultant Job Location:
Remote
Full Time Employment with Capgemini Engineering
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.
Key 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.
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.
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.
Life at Capgemini: Flexible work Healthcare including dental, vision, mental health, and well-being programs Financial well-being programs such as 401(k) and Employee Share Ownership Plan Paid time off and paid holidays Paid parental leave Family building benefits like adoption assistance, surrogacy, and cryopreservation Social well-being benefits like subsidized back-up child/elder care and tutoring Mentoring, coaching and learning programs Employee Resource Groups Disaster Relief
About Capgemini Engineering: World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse group of 340,000 team members in more than 50 countries. #J-18808-Ljbffr