Project Role : Application Support Engineer
Project Role Description : Act as software detectives, provide a dynamic service identifying and solving issues within multiple components of critical business systems.
Must have skills : Veeva Vault
Good to have skills : NA
Minimum
7.5 year(s) of experience is required
Educational Qualification : 15 years full time education
Summary:
We are seeking an experienced and motivated Associate Manager with strong expertise in Veeva Vault RIM (Regulatory Information Management) and data migration projects within the life sciences or pharmaceutical domain. The ideal candidate will lead end-to-end implementation and migration efforts, ensuring timely delivery, quality, and alignment with regulatory requirements.
Roles & Responsibilities:
- Manage the implementation and configuration of Veeva Vault RIM modules (Registrations, Submissions, Submissions Archive, Product, and Health Authority).
- Manage data migration lifecycle: planning, data mapping, extraction, transformation, loading (ETL), and validation from legacy systems to Veeva Vault RIM.
- Collaborate with cross-functional teams including regulatory, QA, IT, and business stakeholders.
- Define and manage project plans, timelines, resources, and deliverables.
- Ensure compliance with regulatory standards (e.g., FDA, EMA) and Veeva best practices.
- Act as the point of contact for issue resolution, escalations, and stakeholder communication.
- Guide a team of analysts and developers provide coaching, task assignment, and performance feedback.
- Participate in solution design sessions, configuration workshops, UAT, and post-go-live support.
- Support the creation and review of functional and technical documentation including SOPs, configuration specs, and migration strategy documents.
- Monitor and report progress, risks, and mitigation strategies to leadership
Professional & Technical Skills:
- 8–12 years of total experience with minimum 5–7 years of hands-on experience in Veeva Vault RIM implementation and/or migration.
- Proven experience in leading data migration projects involving Veeva Vault or similar regulatory systems.
- Strong understanding of Regulatory Affairs processes and global health authority requirements.
- In depth understanding of Veeva Vault Admin/Config tools and Veeva migration tools (e.g., Vault Command Line, Vault Loader, Vault APIs).
- Good working knowledge of Vault to Vault and Non-Vault to Vault Integrations
- Excellent communication and stakeholder management skills.
- Familiarity with GxP compliance, 21 CFR Part 11, and validation requirements.
- Experience in Agile or hybrid project methodologies.
- Strong analytical and problem-solving abilities.
- Veeva Vault RIM Certification(s).
- Ability to configure and manage Vault SDKs will be plus
- Experience in life sciences consulting or working with top-tier pharma clients.
- Exposure to integration projects involving Veeva Vault (e.g., with RIM, PromoMats, Quality).
- Knowledge of tools like ETL platforms, SQL, Excel macros, or custom migration scripts.
Additional Information:
- The candidate should have a minimum of 8+ years of experience in Veeva Vault implementations/configuration update/data migrations
- Candidate should have experience in Veeva Vault module implementation or configuration changes.
- A 15-year full-time education is required
