Freelance RA specialist eCTD
SIRE
Utrecht, The Netherlands
13 dagen geleden

The company

Our client is a professional Pharmaceutical organization, based in Utrecht Netherlands. Our client is a global pharmaceutical company.

Role description

This role has been created to get a large eCTD-project started. You will be part of an RIMS project to get the diverse regulatory affairs department ready to make the transfer towards the eCTD program.

This project will take up to 6 months with the possibility to get prolonged if there are more tasks that need your expertise.

The project will be full time on-site but occasional homebased work will be possible.

You will report to the RA project manager.

Responsibilities

You will be required to help set up the data system to prepare for the datamigration towards the eCTD program. Your experience on a RA department and your knowledge of RA document setup will be an asset to your design and implementation of the system.

It is your goal to create the platform that facilitates the data migration, make sure that all applications within the various departments are integrated and work fluently.

Requirements

  • A degree in pharmaceutics or chemistry
  • Experience on a pharmaceutical Regulatory Affairs department and average CTD-knowledge
  • Experience with eCTD-tools, system documentation
  • MS office
  • Organized personality
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