CMC Writer

  • Ghent, BE
  • 2 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 (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

Your profile

Education and experience

  • 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

General Skills

  • Excellent writing and communication skills
  • Very good knowledge of English is required
  • Proficiency with MS Office (mainly Word, Excel)
  • Good planning and organizational skills with demonstrated ability to deliver work on-time
  • Customer-oriented and quality conscious attitude
  • Eye for detail
  • Accurate
  • Critical mind
  • Problem-solver
  • You have a proactive attitude, and you dare to think out-of-the box
  • Eager to learn
  • Team player

We offer

  • 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

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