CMC Writer

  • Ghent, BE
  • 3 months ago

Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development services.

The Ardena Group is operating from six sites in Europe. For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for a

CMC Writer

 

YOUR KEY ROLE

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. At Ardena, we are experts in writing scientific reports using a dossier-centric approach. This means we keep the final dossier submission in mind throughout in order 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.

YOUR KEY RESPONSIBILITIES

  • 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.

YOUR PROFILE

  • Master’s degree or Ph. D. in a scientific discipline e.g., pharmacy, biotechnology, biomedical sciences, chemistry 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

WE OFFER

  • An attractive and tailor-made remuneration package including extra-legal benefits such as
    • Compensation if you come to work by bike
    • Daily meal vouchers
    • Group/hospitalization insurance
  • Flexible working hours
  • 32 days holiday per year
  • Ability to grow your skills in a rapidly growing company with international customer portfolio
  • A dynamic working environment

If interested, please contact us and send us your cv and motivation letter via our website ardena.com/careers or email at hr@ardena.com