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, The Netherlands, Sweden, Latvia and Spain. 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.
For Ardena’s Dossier Development Team, based in Ghent we are looking for multiple people to join the team in the role of
ASSOCIATE CMC REGULATORY SCIENTIST (starter job)
The Dossier Development team brings tailored and timely services to Ardena customers in the very broad sense of regulatory drug development services. We support any type of Chemistry, Manufacturing & Control (CMC) writing activity at all stages of the drug development process. We also give regulatory CMC advice to our customers in collaboration with the Ardena team during drug development and dossier submission.
The function of an associate CMC regulatory scientist is considered to be a starter job. You will collaborate closely with your colleagues, and you will be part of the drug development process by writing regulatory qualitative documents.
WHAT YOU WILL WORK ON
YOUR KEY RESPONSIBILITIES
- Writing or compiling scientific and technical documents (protocols, reports, assessments, ...) related to drug substance, drug product, and analytical development activities for new chemical entities as well as biological products. These documents may be used as basis for global regulatory submissions (clinical trial applications, marketing applications, ...)
- Writing or compiling the quality part (Module 3) of clinical trial applications and marketing applications
YOUR PROFILE LOOKS LIKE/ RESEMBLES
Education and Interest:
- Master’s degree in a scientific discipline e.g., pharmacy, biotechnology, biomedical sciences, chemistry or similar.
- Passion for scientific and/or technical writing for chemical and/or biopharmaceutical products
- Strong interest in regulatory guidelines
- Knowledge in drug development is a plus
- Good communication skills (both written and spoken)
- Good knowledge of English, written and spoken
- Good scientific writing skills
- Attention to detail and accuracy
- Proficiency with MS Office (mainly Word, Excel)
- Ability to work independently, when necessary
- Quality conscious attitude
WHAT WE OFFER
- Being part in the development of new drugs
- 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
- An attractive remuneration package
- Flexible working hours and possibility for partly telework
Ready to apply? Please click on the application button
If you like to have more information about the role, please do not hesitate to contact Stijn Maertens, email: Stijn.Maertens@ardena.com, Tel: +32 (0) 9 267 65 00.