Job Description

Veeva Publishing SME

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Role

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Veeva Publishing specialist/ Veeva RIM Specialist.

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Mandate to be Certified Veeva Vault Platform Certified Administrator

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Responsibilities

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Publish regulatory submissions using Veeva Vault RIM or other Veeva Vault applications (e.g., Vault Submissions, Vault Submissions Archive).

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Support document preparation, formatting, hyperlinking, bookmarking, and validation for regulatory submissions (e.g., IND, NDA, CTA, MAA).

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Ensure submission packages meet applicable eCTD standards and global regulatory requirements.

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Collaborate with Regulatory Affairs, Regulatory Operations, and Document Management teams to ensure submission readiness.

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Maintain submission trackers, timelines,



and communication logs within Veeva. Provide technical support for Veeva Vault publishing tools and workflows.

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Participate in publishing process optimization and ensure compliance with SOPs and GxP guidelines.

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Skills required

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Experience and Certification with Veeva Vault RIM or Veeva Submissions is required.

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Preferred Skills: Familiarity with health authority portals (e.g., ESG, EMA Gateway).

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Knowledge of submission lifecycle from authoring to archival. GxP and 21 CFR Part 11 compliance experience.

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