About us

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, manufacturing, logistics and bioanalytical services. 
The Ardena Group is operating from five sites in Europe and one in US. 

For the Ardena branch based in Gent, Belgium, our CMC Regulatory Team is looking for a

Scientific/Technical Writer with focus on Biotechnology

The CMC Regulatory team is dedicated to delivering customized and timely regulatory drug development services to our valued customers. Our support spans all aspects of Chemistry, Manufacturing & Control (CMC) writing activities across various stages of the drug development process. We collaborate closely with other Ardena teams, providing CMC advice throughout drug development and dossier submission.

Position Overview:

As a Scientific/Technical Writer with focus on biotechnology, you will play a key role in supporting process development by preparing high-quality scientific and technical documentation. This position offers an excellent opportunity to collaborate with experienced professionals and gain hands-on exposure to the dynamic and fast-evolving biotech field.

Key Responsibilities:

• Author and compile scientific and technical documents related to the development of biotech products, including:
• ICH M7 Nitrosamine Risk Assessments
• Criticality Analyses
• Process Development Reports
• Other supporting documents for global regulatory submissions (e.g., clinical trial applications, marketing authorizations)
• Coordinate and manage technical writing, review and approval activities across projects
• Ensure documents are aligned with current ICH and other relevant regulatory guidelines
• Making sure timelines are met
• Ensuring that the documentation is of high quality and that potential issues are discussed with the customer

Your Profile:

Education and Interest:

• Master’s degree or Ph.D. in Biotechnology, Bioengineering, or a related discipline.
  
• Strong interest in drug development, regulatory science, and technical/scientific writing for chemical and biological products

Skills & Competencies:

• Excellent written and verbal communication skills
  
• Fluency in English (both written and spoken)
  
• Proficiency in MS Office (particularly Word and Excel)
  
• Strong scientific writing and documentation skills with keen attention to detail
  
• Highly organized, with the ability to prioritize and adapt in a dynamic environment
  
• Independent, proactive, and eager to learn
  
• Analytical mindset with problem-solving skills and a strong quality focus

What We Offer:

• Opportunity to contribute to the development of new drugs.
  
• A supportive learning environment for skill development and growth.
  
• Involvement in a rapidly growing international company with an intriguing services, product, and customer portfolio.
  
• Dynamic working environment with friendly and collaborative colleagues.
  
• Open, straightforward, and caring company culture.
  
• Attractive remuneration package.
  
• Flexible working hours and the possibility for partial telework.
  
• Generous annual leave entitlement of 32 days.

Join us in shaping the future of drug development and be part of a team that values your contributions and personal growth. Apply now and embark on an exciting journey with us!

Ready to apply? Please click on the application button

For more information about the role, please contact HR.

Email: HR@ardena.com