(Associate) Scientific Writer – CMC Drug Product at Ardena

Ghent, Flemish Region, Belgium -

Full Time

Start Date

Immediate

Expiry Date

12 Mar, 26

Salary

0.0

Posted On

12 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Scientific Writing, Data Analysis, Communication Skills, Attention to Detail, Problem-Solving Skills, MS Office, Regulatory Guidelines, Drug Development, Quality Assurance, Team Collaboration, Independent Work, Dynamic Environment, Technical Writing, Customer Interaction, Time Management, Learning Agility

Industry

Pharmaceutical Manufacturing

Description

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 (Associate) Scientific Writer – CMC Drug Product 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 (Associate) Scientific Writer – CMC Drug Product, you will play a pivotal role in the drug product development process by contributing to the creation of qualitative documents. This position offers a fantastic opportunity to collaborate with experienced colleagues and gain firsthand experience in the dynamic field of drug product development. Key Responsibilities: Write and compile scientific and technical documents related to drug product development such as: 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 Your Profile: Education and Interest: Master’s degree in Pharmaceutical Sciences. Passion for scientific and technical writing for chemical and biopharmaceutical products. Strong interest in drug development and regulatory guidelines. General Skills: Very good communication skills (both written and spoken). Fluent in written and spoken English. Strong scientific writing skills. Attention to detail and accuracy. Eager to learn and ability to work independently when necessary. Proficient in MS Office (primarily Word and Excel). Problem-solving skills with a quality-conscious attitude. Well-organized with the ability to work in a dynamic environment. 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

Responsibilities

The (Associate) Scientific Writer will write and compile scientific and technical documents related to drug product development. Responsibilities include data analysis, coordinating review activities, ensuring timelines are met, and maintaining high-quality documentation.