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  • Location

    ZUID HOLLAND, Netherlands

  • Job title:

    RA Submission Technical Expert

  • Sector:

  • Job ref:

    45375

  • Start Date:

    2020-11-27

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 vaccines to protect people worldwide from infectious diseases.

Role Description 
As a Submission Technical Specialist you will support the software used for publications of regulatory submissions to governments on a global level. 

Responsibilities
- Support current electronic document management and publishing tools to assemble and publish dossiers. 
- Troubleshoot and provide first-line support to RSMO Publishing regarding regulatory submissions and guidelines. 
- Monitor electronic publishing requirements. 
- Develop opportunities for business process improvement. 
- Assist in technical training team members & provide ongoing guidance to ensure internal standards/procedures. 


Requirements 
- BSc or higher level of thinking. Computer Science academic training. 
- 5+ years of experience in pharmaceutical industry submission publishing or related technical skills. 
- Proficiency in submission related FDA or EU regulations & guidelines. 
- Expert working knowledge of Publishing related tools, like InSight Publisher, ISI Publisher, InSight for Validation, Extedo Global Validator, Lorenz eValidator,  InSight for Viewing, ISI Toolbox.
- Strong communication skills in English. 


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
+31 (0) 20 658 9804

SIRE LIFE SCIENCES DEUTSCHLAND GmbH

Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SINCERE. INTELLIGENT. RESULT-DRIVEN. EXCELLENCE.