Veeva Publishing SME
Role
Veeva Publishing specialist/ Veeva RIM Specialist.
Mandate to be Certified Veeva Vault Platform Certified Administrator
Responsibilities
- Publish regulatory submissions using Veeva Vault RIM or other Veeva Vault applications (e.g., Vault Submissions, Vault Submissions Archive).
- Support document preparation, formatting, hyperlinking, bookmarking, and validation for regulatory submissions (e.g., IND, NDA, CTA, MAA).
- Ensure submission packages meet applicable eCTD standards and global regulatory requirements.
- Collaborate with Regulatory Affairs, Regulatory Operations, and Document Management teams to ensure submission readiness.
- Maintain submission trackers, timelines, and communication logs within Veeva. Provide technical support for Veeva Vault publishing tools and workflows.
- Participate in publishing process optimization and ensure compliance with SOPs and GxP guidelines.
Skills required
- Experience and Certification with Veeva Vault RIM or Veeva Submissions is required.
- Preferred Skills: Familiarity with health authority portals (e.g., ESG, EMA Gateway).
- Knowledge of submission lifecycle from authoring to archival. GxP and 21 CFR Part 11 compliance experience.
