Veeva RIM Consultant
2 months ago
Description
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:
oManage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM.
oEnsure that regulatory submissions comply with applicable local and international regulations and guidelines.
oMaintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents.
· System Configuration and Maintenance:
oConfigure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows.
oMonitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution.
· Data Management:
oEnsure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones.
oImplement data governance practices to maintain compliance and quality of regulatory data.
· Cross-Functional Collaboration:
oCollaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions.
oAct as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities.
· Process Improvement:
oIdentify opportunities for process enhancements and automation within the regulatory submission process.
oDevelop and implement standard operating procedures (SOPs) for the use of Veeva Vault RIM.
· Regulatory Compliance:
oStay updated on regulatory changes and ensure that the organization’s processes and systems comply with current regulations and industry best practices.
oParticipate 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 certificationis 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
-
Veeva RIM Consultant
2 months ago
Boston, United States Capgemini Full timeJob Title: Veeva RIM ConsultantMake your application after reading the following skill and qualification requirements for this position.Job Location: RemoteFull Time Employment with Capgemini EngineeringJob Description:We are seeking a highly skilled Veeva RIM Consultant to manage and optimize our regulatory information management processes using the Veeva...
-
Veeva RIM Consultant
2 months ago
Boston, United States Capgemini Full timeJob Title: Veeva RIM ConsultantJob Location: RemoteFull Time Employment with Capgemini EngineeringJob 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...
-
Regulatory Affairs Consultant
4 weeks ago
Boston, Massachusetts, United States Capgemini Full timeRegulatory Affairs ConsultantCapgemini is seeking a highly skilled Regulatory Affairs 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...
-
Veeva Quality Management System
2 months ago
Boston, United States Capgemini Full timeVeeva Quality Management System (QMS) Consultant-077233 Description Job Title: Veeva Quality Management System (QMS) Consultant Job Location: Remote Full Time Employment with Capgemini Engineering Job Description: We are seeking a highly motivated Veeva Quality Management System (QMS) Consultant to support the implementation,...
-
Business Analyst
3 weeks ago
Boston, United States ClearBridge Technology Group Full timeOur client, a Leading Professional Services and Business Consulting company is in need of a Business Analyst for a 6-month contract to hire position in Boston, MA. The BA will act as the QA lead. They are going to be working with both their internal IT and customers to build workflows and processes within their Veeva QMS. They will implement and configure...
-
Computer System Validation Lead
1 month ago
Boston, United States Arrayo Full timeAs a validation strategist, you will lead the development and execution of compliant and nimble validation strategies for cloud based (SaaS, PaaS) clinical, regulatory, and safety applications. Responsibilities: Define overall validation strategy and approach for Digital Clinical CSV projects in a digital context (cloud, automation, AI) and in alignment...
-
Boston, United States Ernst and Young Full timeAt EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better. Join us and build an exceptional experience for yourself, and a better working world for all.The...
-
Computer System Validation Lead
2 weeks ago
Boston, MA, United States Arrayo Full timeAs a validation strategist, you will lead the development and execution of compliant and nimble validation strategies for cloud based (SaaS, PaaS) clinical, regulatory, and safety applications. Responsibilities: Define overall validation strategy and approach for Digital Clinical CSV projects in a digital context (cloud, automation, AI) and in alignment with...
-
Boston, MA, United States Ernst and Young Full timeAt EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better. Join us and build an exceptional experience for yourself, and a better working world for all. The...
-
boston, United States Ehub Global Inc Full timeCommercial Data Lead ArchitectBoston MAFULLTIME 1. Data Modeling – for a Data Warehouse Environment - Must have2. Patient Data (HCP) – Must have3. 5+ years of experience in Pharmaceuticals – Must HaveJDRoles And ResponsibilitiesDevelop and execute a comprehensive data architecture strategy for Commercial and Medical Affairs, aligning with...
-
Commercial Data Lead Architect
4 weeks ago
Boston, United States Ehub Global Inc Full timeCommercial Data Lead ArchitectBoston MAFULLTIME 1. Data Modeling – for a Data Warehouse Environment - Must have2. Patient Data (HCP) – Must have3. 5+ years of experience in Pharmaceuticals – Must HaveJDRoles And ResponsibilitiesDevelop and execute a comprehensive data architecture strategy for Commercial and Medical Affairs, aligning with...
-
Program Manager Commercial
2 weeks ago
Boston, United States The Computer Merchant, LTD. Full timeJOB TITLE: Program Manager Commercial & Medical AffairsInterested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed.JOB LOCATION: Boston, MAWAGE RANGE*: $90-$100JOB NUMBER: 24-02126REQUIRED EXPERIENCE:Minimum: Bachelor's Degree required • Medical Affairs and Evidence Generation...
-
Commercial Data Architecture Lead
1 month ago
Boston, United States argenx Full timeJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...
-
Director, US Medical Affairs Operations
2 days ago
Boston, United States argenx Full timeJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...
-
Boston, United States Vertex Pharmaceuticals Incorporated Full timeJob DescriptionAs the Associate Director of Sales Planning and Incentive Compensation you will be responsible for the administration, execution, and delivery of our Sales Planning & Incentive Compensation (IC) services for the Pain BU. This includes the sales team alignments, targeting, and incentive compensation deliverables. You will be a strong...
-
Business Analyst
4 weeks ago
Boston, United States Indegene Full timeWe are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion,...
-
Indegene | Business Analyst | boston, ma
4 weeks ago
boston, United States Indegene Full timeWe are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion,...
-
Business Analyst
4 weeks ago
Boston, United States Indegene Full timeWe are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion,...
-
Boston, United States Vertex Pharmaceuticals, Inc Full timeJob Description As the Associate Director of Sales Planning and Incentive Compensation you will be responsible for the administration, execution, and delivery of our Sales Planning & Incentive Compensation (IC) services for the Pain BU. This includes the sales team alignments, targeting, and incentive compensation deliverables. You will be a strong...
-
Clinical Data Management Expert
3 weeks ago
Boston, Massachusetts, United States KCR Full timeJob Title: Clinical Data Management Expert - US Team">About the Role:We are seeking a highly skilled and experienced Clinical Data Management Expert to join our US team. In this role, you will play a critical part in advancing drug and vaccine development programs by overseeing all aspects of data management activities.Key Responsibilities:Lead, plan, and...
