Vertex Pharmaceuticals

eCTD Publishing Manager, Regulatory Affairs – Contract

Vertex Pharmaceuticals

contract

Posted on:

Location Type: Hybrid

Location: United States

Visit company website

Explore more

AI Apply
Apply

Salary

💰 $60 - $70 per hour

Tech Stack

About the role

  • 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  • Identifying out of date eCTD relationships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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
eCTD publishingdata mappingmetadata managementdata migrationend user testingExcelVlookuppivot tablesdata modelssubmission types
Soft skills
organizational skillstask managementcollaborationcommunication