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

Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:

• 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. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

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. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.

Get the Future You Want | www.capgemini.com

Disclaimer

Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.

Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.