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.

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