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  • Location

    Zuid-Holland , Netherlands

  • Job title:

    Submission Technical Expert

  • Sector:

  • Job ref:

    46108

  • Start Date:

    2021-05-04

The Company 
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of biologics to protect people worldwide from immunological diseases.

Role Description 
As a Submission Technical Expert you will provide support regarding the tools used for electronic publishing of regulatory submissions. 

Responsibilities 
- Support current electronic document management and publishing tools to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions.
- Troubleshoot and provide first-line support to RSMO Publishing.
- Monitor electronic publishing requirements and determine the scope for tool maintenance/development.
- Support training of junior specialists and oversee the work of others from an operational perspective. 
- Provide expertise in eCTD lifecycle standards and requirements. 
- Process improvement initiatives, testing and implementation of new submission related technologies.


Requirements 
- Bachelor's degree in computer science or equivalent
- Min 2 years of experience in pharmaceutical industry submission publishing 
- Proficiency in submission related FDA or EU regulations & guidelines e.g. eCTD
- Working knowledge of Publishing related tools like InSight Publisher ISI Publisher InSight for Validation Extedo Global Validator Lorenz eValidator InSight for Viewing ISI Toolbox etc. 


Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 

Contact us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804