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 about 320 professionals operating from 6 sites in Belgium (Gent), The Netherlands (Amsterdam, Oss, Assen), 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.
For the Ardena Business Unit based in Ghent, Belgium, we are looking for a
CMC Writer (Project Management Support)
What you will work on
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
- Writing 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), 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
YOUR PROFILE LOOKS LIKE/ RESEMBLES
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
- 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
- Critical mind
- You have a proactive attitude, and you dare to think out-of-the box
- Eager to learn
- Team player
WHAT WE OFFER
- A true learning environment where you will have the ability to grow your skills
- A rapidly developing and growing international company with an attractive 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
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.
Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in Belgium) will not be given a status update.
Agency calls will not be appreciated.