For one of our clients in the area of Brussel (South-West), we are looking for a Regulatory Affairs Assistant with great language skills. This for a period of 6 months.
- Do you have a first experience in clinical research?
- Are you fluent in English, French and Dutch?
- Are you familiar with electronic tracking systems?
Then send me your CV as soon as possible!
- Administrative support in compiling, submitting and closing variations.
- Review of translations (English-French-Dutch-German?).
- Filing and Archiving of regulatory dossiers/files/documents according to the requirements of the company -Tp, RecPoint (backlog), GPRS (to start)-
- Tracking: 4 eye review in GPRS
- Searching documents in GPRS (market access support)
- SmPC/PL distribution
- ALPIN / Proofware (text/proofs verification tool)
Clinical Trial Applications
- Administrative support in compiling and submitting initial CTA and amendments, notification of DIL,….
- Tracking, Filing and Archiving of dossiers/files/documents according to the company requirements
- Preferably a first experience in clinical research or a similar position
- Fluent in Dutch, French, English. If you know German, that would be even better.
- Excellent administrative skills: detail oriented, good time management, conscientious, ...
015 21 11 04