Project Manager Services
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.