Ardena’s Dossier Development team brings tailored and timely services to our customers in the very broad sense of regulatory services. We provide support by writing CMC regulatory documents (e.g., MAAs/NDAs, IMPDs/INDs, variations, etc.) but also scientific reports for diverse customers & projects. As a CMC Writer, you have a passion for (technical/scientific) writing and the drive to generate qualitative reports in collaboration with the dossier development team. 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.

Your key responsibilities

• Writing regulatory documents and scientifically-sound source documents related to drug development activities which may be used as basis for global regulatory submissions (MAA, NDA, BLA), including:
  • Writing the documents
  • Data analysis
  • Coordination of the review and approval activities
  • Making sure timelines are met
  • Ensuring that the documentation is of high quality and that potential issues are discussed with the customers
• Project management support during drug product development activities performed by customers, including:
  • Project overview
  • Follow up of action items until completion
  • Ensuring timelines are met
  • Drafting and reviewing related documents
  • Data review to ensure compliance with product specifications, and/or protocol acceptance criteria
  • Attending meetings organized by the customer
  • Organizing and leading meetings (including drafting meeting minutes)

Your profile looks like/resembles

Education and experience:

• You are a young graduate with a Master’s degree or Ph. D. in a scientific discipline e.g., pharmacy, biotechnology or similar. Affinity with drug product development is a plus.

• A first working experience with scientific and/or technical writing is a plus.

• Basic knowledge and understanding of pharmaceutical principles in various fields

General skills:

• Strong communication skills (both written and spoken)

• Professional knowledge of English is required

• Good scientific writing skills

• Well organized and able to handle multiple projects in parallel

• Ability to work independently and under time-pressure

• You have a proactive attitude, and you dare to think out-of-the box

• Customer-oriented and quality conscious attitude

• Eye for detail

What we offer

• A true learning environment where you will have the ability to grow your skills

• A rapidly international developing and growing company with an interesting services, product and customer portfolio

• A dynamic working environment with nice colleagues

• Open straightforward but also caring culture

• We are true to our values

• An attractive remuneration package

• Flexible working hours

• 32 days holiday a year

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.

Ardena is a rapidly growing international orientated organization with a dedicated team of over 500 professionals operating from 7 sites in Belgium (Gent), The Netherlands (Amsterdam, Oss, Assen), Spain (Pamplona), Sweden (Sodertalje), and Latvia (Riga). Ardena has an open and transparent culture: team-spirit, an open mindset and ownership are important values in our company.

We are a dynamic drug developer offering exciting career opportunities to skilled and motivated people who want to work in a fast-growing market within the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to develop innovative drugs for unmet medical needs? Do you want to further develop Ardena and grow with us by becoming our next colleague? Then we might have the right opportunity for you.

If you like to have more information about the role, please do not hesitate to contact Stijn Maertens, email: HR@ardena.com, Tel: +32 9 267 65 00.

 Agency calls will not be appreciated.