12 Oct
|
Cerebra
|
Hyderabad
Role & responsibilities
Job Title: Senior Veeva Vault RIM / Active Dossier Project Manager
Experience: 12+ Years
Location: Remote
Job Summary
We are looking for an experienced Veeva Vault RIM / Active Dossier Project Manager with 12+ years of experience in Life Sciences IT or Regulatory Affairs and at least 5 years of project/program management experience.
The ideal candidate should have strong hands-on functional experience in Veeva Vault RIM, Active Dossier management, Regulatory Information Management (RIM), eCTD, regulatory submissions, and end-to-end Veeva RIM implementations/migrations.
Key Responsibilities
- Lead end-to-end Veeva Vault RIM implementations and migrations, including legacy-to-Vault data migration.
- Manage Veeva Vault Active Dossier processes and regulatory submission activities.
- Plan and execute RIM migration waves, mock migrations, data reconciliation, cutover and rollback activities.
- Manage Registrations, Submissions, Content Plans and related RIM data.
- Work with business and regulatory stakeholders to define migration and implementation requirements.
- Coordinate onshore/offshore teams, vendors and cross-functional stakeholders.
- Manage project timelines, risks, dependencies, issues and stakeholder communication.
- Ensure successful delivery of migration and implementation activities within agreed timelines.
- Support data migration using Vault Loader, Migration Mode and REST APIs.
- Ensure data quality and reconciliation between legacy systems and Veeva Vault.
- Work closely with technical teams on integrations and migration-related activities.
Mandatory Skills
- 12+ years of experience in Life Sciences IT / Regulatory Affairs.
- 5+ years of Project Management / Program Management experience.
- Strong experience in Veeva Vault RIM.
- Hands-on/functional experience with Veeva Vault Active Dossier.
- Experience in 2+ end-to-end Veeva Vault RIM implementations or migrations.
- Strong experience in legacy-to-Vault data migration.
- Positive understanding of eCTD and regulatory processes.
- Knowledge of eCTD Modules M1M5, sequences, lifecycle management, variations and renewals.
- Experience with Vault Registrations, Vault Submissions and Content Plans.
- Knowledge of Vault Loader, REST API and Migration Mode.
- Strong migration delivery experience including wave planning, mock migrations, reconciliation, cutover and rollback.
- Strong stakeholder, risk and vendor management skills.
- Experience managing onshore/offshore teams.
Good to Have
- GxP experience.
- CSV / Computer System Validation experience.
- Integration experience with SAP, SnapLogic, MuleSoft or Labeling systems.
- PMP or SAFe certification.
- Veeva Vault RIM certification.
- Experience in pharmaceutical / biotechnology / life sciences organizations.
📌 Senior Veeva Vault RIM (Hyderabad)
🏢 Cerebra
📍 Hyderabad