Executive Director leading firm - wide Compliance Risk Assessment program for SMBC Group in financial services. Managing CRA process and collaborating with regulatory stakeholders.
About the role
- eCTD publishing Manager supporting data mapping of eCTD metadata for Vertex Pharmaceuticals. Involves Excel work against data extracts from Veeva Vault RIM with a focus on eCTD 4.0 submissions.
Responsibilities
- Support data mapping of eCTD metadata from legacy publishing system into future state system
- Support activities in preparation of enabling eCTD 4.0 submissions
- Work mostly conducted in Excel, working against data extracts from Veeva Vault RIM
- Own portions of the data migration mapping to enable Veeva Publishing as well as preparation activities for eCTD 4.0 enablement, including, but not limited to:
- Mapping legacy eCTD metadata into Veeva RIM relationships
- Identifying out of date eCTD relationships
- Suggesting updates to align with historical dossiers and enable future lifecycle management
- Corrections to the Veeva RIM archive as needed
- Mapping of current submission types and subtypes against Veeva and HA recommended nomenclature
- Mapping of existing submission records and fields into updated data models and fields
- Mapping eCTD 4.0 functionality in Veeva Publishing and executing end user testing as needed
Requirements
- Bachelor's degree, with a preference for life sciences or technology area
- Typically requires at least five to seven years hands-on technical experience with eCTD publishing, either in Veeva Vault or similar publishing tools
- Experience with Veeva Vault RIM
- In depth hands on experience with eCTD publishing software, detailed understanding of eCTD metadata
- Proficient in Microsoft Office, especially Excel and formulas, e.g. Vlookup and pivot tables.
- Ability to organize and manage tasks with firm deadlines
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner.
Benefits
- Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
- Overtime pay, in accordance with federal and state requirements
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