Voor een bedrijf in Mariakerke zijn wij op zoek naar een Technical Writer:
You should have a passion for (technical/scientific) writing and the drive to generate qualitative reports in collaboration with the dossier development team.
Your key responsibilities
- Authoring scientifically sound source documents related to drug development activities (such as formulation development reports, criticality assessments, manufacturing reports, etc.) which may be used as basis for global regulatory submissions (MAA, NDA, BLA)
- Data analysis
- Review of data to ensure compliance with product specifications, and/or protocol acceptance criteria
- Project management/coordination of technical writing and reviewing activities
- Ensure that the documentation is of high quality and that potential issues are discussed with our customers
- Master’s degree or Ph. D. in a scientific discipline e.g., pharmacy, biotechnology or similar.
- Affinity with drug product development is a plus.
- Working experience with scientific and/or technical writing is a plus.
- Basic knowledge and understanding of regulatory guidelines, manufacturing processes, analytical methods, specifications, formulation development, method validation, process validation
Wat je van ons krijgt
- An attractive and tailor-made remuneration package including extra-legal benefits
- Ability to grow your skills in a rapidly growing company with international customer portfolio
- A dynamic working environment