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Remote Status:
Hybrid
Compensation:
$48 - $55 / hr
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This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted.
Position SummaryThis Regulatory Operations eCTD Migration Support Manager role supports the migration and mapping of eCTD metadata from a legacy publishing system into a future-state system while preparing for eCTD 4.0 submissions. The position involves project work primarily in Excel using data extracts from Veeva Vault RIM and requires expertise in eCTD structure, metadata, and publishing processes. The work begins in a development environment and progresses to production once validated.
Key Duties & Responsibilities
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Own portions of the data migration mapping to enable publishing and support activities for eCTD 4.0 enablement.
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Map legacy eCTD metadata into Veeva RIM relationships.
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Identify outdated eCTD relationships and recommend updates to align with historical dossiers and support future lifecycle management.
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Perform corrections to the Veeva RIM archive as needed.
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Map current submission types and subtypes against Veeva and Health Authority (HA) recommended nomenclature.
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Map existing submission records and fields into updated data models.
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Support mapping of eCTD 4.0 functionality in Veeva Publishing and conduct end-user testing as required.
Required Education
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Bachelor’s degree, preferably in life sciences or a technology-related field.
Required Experience
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Typically requires 5–7 years of hands-on technical experience with eCTD publishing in Veeva Vault or comparable publishing tools.
Required Knowledge & Skills
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Strong experience with Veeva Vault RIM.
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In-depth, hands-on knowledge of eCTD publishing software and metadata requirements.
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Proficiency in Microsoft Excel, including formulas, VLOOKUP, and pivot tables.
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Strong organizational skills with the ability to manage tasks against firm deadlines.
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Effective communication and collaboration skills, with the ability to work clearly and consistently with cross-functional teams.
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