Veeva Vault RIM / Regulatory Technology SME

Overview

We are looking for a senior Veeva Vault RIM specialist with
strong pharmaceutical regulatory technology experience to provide independent
advisory support for a major regulatory transformation programme.

The consultant will assess implementation approaches,
dependencies, risks and key technology decisions associated with Veeva Vault
RIM and the wider regulatory technology landscape.

Key Responsibilities

• Provide
  independent assessment of Veeva Vault RIM implementation strategy.
  
• Evaluate
  phased, staggered and big-bang implementation options.
  
• Assess
  regulatory, migration and cross-release dependencies.
  
• Provide
  recommendations on key design and implementation decisions.
  
• Document
  options, risks, dependencies and trade-offs.
  
• Assess
  dependencies between Vaults, workstreams, releases and external partners.
  
• Review
  configuration and integration considerations.
  
• Assess
  MDM, testing, validation and business-readiness dependencies.
  
• Support
  regulatory transformation and release-readiness assessments.
  
• Provide
  technical and strategic input into governance and executive decision
  materials.
  
• Support
  data migration assessments where relevant.
  
• Provide
  input into cutover and go-live readiness.
  
• Work
  with Regulatory Affairs, IT, System Integrators and technology partners.
  

Requirements

Essential Experience

• Valid
  Veeva Vault certification relevant to the services.
  
• Significant
  enterprise-scale Veeva Vault RIM implementation experience.
  
• Senior-level
  experience within pharmaceutical/life sciences.
  
• Strong
  regulatory technology transformation experience.
  
• Experience
  working with complex enterprise technology landscapes.
  
• Experience
  across configuration, integrations, MDM, testing and validation.
  
• Experience
  working in GxP-regulated environments.
  
• Experience
  with large-scale data migration or legacy regulatory-system
  transformation.
  
• Strong
  understanding of programme dependencies and release management.
  
• Ability
  to produce clear recommendations and executive-level decision materials. 
  

Desirable

• Previous
  Novartis experience.
  
• Freeway
  or comparable regulatory-platform transformation experience.
  
• Experience
  with eCAR/ICE or similar governance methodologies.
  
• Experience
  with Dragon or comparable legacy regulatory registration systems.
  

On-site Requirement

Must be available to attend Basel during relevant planning,
governance, validation, cutover and go-live phases.

Ideal Background

Senior Veeva Vault RIM Consultant / Veeva RIM Solution
Architect / Regulatory Technology SME / Veeva Programme Advisor.