ZUID HOLLAND, Netherlands
RA Submission Technical Expert
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.
As a Submission Technical Specialist you will support the software used for publications of regulatory submissions to governments on a global level.
- 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.
- 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.
For more information please contact Carla Garcia at email@example.com or +31 (0) 20 658 98 01.