10 Sep
|
Atos
|
Tamil Nadu
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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📌 Senior Software Engineer (Tamil Nadu)
🏢 Atos
📍 Tamil Nadu