Teva Pharmaceuticals USA, Inc.

Publishing Associate II Regulatory Submission Management

US-PA-Frazer
Requisition #
17-20117
# Positions
1
Experience (Years)
4
Category
Regulatory Affairs - Regulatory Affairs

Overview

 

 

The Publishing Associate II, Regulatory Submissions Management, is responsible for responsible for the publishing and dispatch of major and complex lifecycle management eCTD submissions and ensuring technical validation.  They have proficient knowledge of internal/external publishing standards, electronic publishing/viewing software tools and document management systems.   Independently performs document level publishing activities, troubleshoots document issues and performs quality control checks for submission ready documents. Trains junior staff on processes, standards and tools and delegates publishing tasks.

 

Responsibilities

1. Publish and dispatch major and complex routine/lifecycle management eCTD submission 
2. Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents
3. Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
4. Leads and participates in Global Regulatory Affairs project teams
5. Trains junior staff on processes and tools 

Qualifications

  • Bachelor’s Degree Required, Bachelor’s Degree in Life Sciences or Information Technology Preferred  

    Significant and relevant work experience may be substituted for Bachelor’s degree.

  • Publishing Associate II  2-4 years experience in Regulatory Operations/Regulatory Affairs.  Experience as a publisher for regulatory applications preferred.
  • Publsihing Associate III 4-6 years experience in Regulatory Operations/Regulatory Affairs.   Experience as a publisher for regulatory applications preferred.
  • Experience with eCTD technologies, Microsoft Office, Adobe Acrobat, and Documentum. eCTDXpress or Liquent Insight a plus.
  • Basic understanding of IT infrastructure 
  • Understanding of the drug development process.  Knowledge of generics and branded product development a plus.
  • Working knowledge of industry legislation and best practices.
  • Knowledge of regulations/guidelines governing regulatory submissions. 

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