CMC Writer

CMC Writer

Employee Type

The Dossier Development team brings tailored and timely services to our customers in the very broad sense of regulatory services. We provide support by writing and submitting regulatory documents (e.g. MAAs, IMPDs, variations, etc.) but also scientific reports for diverse customers & projects. We are experts in writing scientific reports using a dossier-centric approach. This means we keep the final dossier submission in mind throughout to ensure consistency, completeness and readability. The candidate should have a passion for (technical/scientific) writing and the drive to generate qualitative reports in collaboration with the dossier development team.

Main tasks:

* Authoring scientifically sound source documents related to drug development activities;

• Coordinating activities with our customers, e.g. for transfer of test methods between different labs;

• Writing CMC regulatory documentation for new filings and clinical trials..


Is it a local employment?
Required Language
Requirements and Qualification

* Master’s degree or Ph. D. in a life science discipline e.g., pharmacy, biotechnology, biomedical sciences or similar. Affinity with drug development is a plus.

• Working experience with scientific and/or technical writing for chemical and/or biopharmaceutical products is a plus.

• Excellent writing and communication skills

• Fluent in English, written and spoken

• Customer-oriented and quality conscious attitude

• Eye for detail

• Proficiency with MS Office (mainly Word, Excel)

• Well organized and able to handle multiple projects in parallel

• Team player


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Years of Experience
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