eCTD publishing Senior Specialist, Regulatory Affairs (Contract) 26119

This role will support data mapping of eCTD metadata from our legacy publishing system into our future state system and support activities in preparation of enabling eCTD 4.0 submissions. The project work will mostly be conducted in Excel, working against data extracts from Veeva Vault RIM and requires a deep understanding of eCTD structure, metadata and organization as well as experience with Veeva Vault RIM. The eCTD 4.0 data mapping will be conducted first in our development environment before moving to production.

Hybrid candidate preferred (3 days in office), open to remote

Key Duties & Responsibilities

Person in this role will 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• Identifying out of date eCTD relationships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.

Required Education Level

• Bachelor's degree, with a preference for life sciences or technology area

Required Experience

• 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
  
   
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$55-$60/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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