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Config Specialist- Veeva Vault (Regulatory Submission/Rims)

5-7 years
Not Disclosed
10 Dec. 7, 2024
Job Description
Job Type: Full Time Education: IT/BE/BCS/BSc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Configuration Specialist Veeva Vault - Regulatory Submissions (RIMS)

Company: Roche Informatics
Location: Not specified


About Roche Informatics

Roche Informatics plays a crucial role in delivering transformative, innovative solutions across major disease areas. Leveraging over 125 years of Roche's expertise, we combine human capabilities with cutting-edge technologies to meet patients' needs. Our goal is to evolve the practice of medicine through technological advancements that improve patient outcomes.

Join our inclusive team, where passion for technological innovation and optimal IT solutions drives everything we do. At Roche, we believe in empowering you to pursue your interests across functions and geographies.


About the Position

As a Configuration Specialist for Veeva Vault: Regulatory Submissions (RIMS), you will be part of the Enterprise Engineering cluster within Roche Informatics. You will collaborate with cross-functional teams and experts to design, implement, and optimize solutions that support regulatory submission management.

This position focuses on Veeva Vault, particularly its role in the Regulatory Information Management System (RIMS). You will be responsible for ensuring the scalability, security, and cost-effectiveness of all aspects of the digital product lifecycle while supporting maintenance activities. Your role will also involve understanding business application processes and functions to deliver optimal IT solutions.


Key Responsibilities

  1. Cross-functional Collaboration & Solution Delivery:

    • Lead and collaborate with internal teams to deliver solutions that meet business requirements.

    • Ensure high quality in technical deliverables, including conducting peer reviews.

  2. Application Development & Deployment:

    • Develop and deploy applications/prototypes using DevOps principles, in line with underlying infrastructure.

    • Lead the implementation and maintenance of efficient Continuous Integration / Continuous Delivery (CI/CD) pipelines to automate the delivery process.

  3. Veeva Expertise & Integration:

    • Act as a subject matter expert for Veeva Vault to ensure reliable and high-performance integrations.

    • Support the design and maintenance of integrations, ensuring efficient data flow and communication between applications.


Qualifications & Experience

Technical Expertise:

  • Veeva Vault Expertise:

    • Understanding of Veeva’s architecture, data models, and integration methods.

    • Proficiency in Veeva configuration tools and integration methodologies.

    • Certification in Veeva platform is a plus.

  • Regulatory Submission Knowledge:

    • Familiarity with regulatory submission processes, regulatory requirements, and standards like Good Clinical Practice (GCP).

  • Compliance & Security Knowledge:

    • Working knowledge of Computer Systems Validation (CSV) and GxP.

    • Knowledge of HIPAA and GDPR regulations in healthcare.

    • Cybersecurity knowledge in the context of clinical data is beneficial.


Education & Experience:

  • Education:

    • Bachelor’s degree in Computer Science, IT, Engineering, or equivalent work experience.

  • Experience:

    • 3-5 years of relevant work experience in IT or life sciences, with at least 3+ years of working in multinational environments.

  • Strong analytical thinking and problem-solving skills.

  • Excellent communication and collaboration skills.


Why Join Roche Informatics?

  • Innovation & Impact: Be part of a team driving technological advancements in healthcare.

  • Global Opportunities: Work across diverse functions and geographies.

  • Passion for Excellence: Collaborate with experts to create solutions that transform medicine.

  • Diversity & Inclusion: Thrive in a culture that values individuality and fosters inclusivity.


Roche is an Equal Opportunity Employer.
We encourage individuals from all backgrounds to apply and contribute to our mission of improving lives worldwide.

Apply Today to be part of Roche Informatics and help shape the future of healthcare!