(Associate) Scientific Writer – CMC Drug Product

Ardena; Gent; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Ardena is seeking an (Associate) Scientific Writer for its CMC Regulatory Team in Wondelgem, Belgium. The role involves writing and compiling essential documents for drug product development, requiring a Master's in Pharmaceutical Sciences and strong scientific writing skills. Join a dynamic team and contribute to innovative drug development while enjoying a supportive work environment and attractive benefits.

Prestations

Flexible working hours

Generous annual leave entitlement of 32 days

Attractive remuneration package

Supportive learning environment

Qualifications

• Master’s degree in Pharmaceutical Sciences required.
• Strong interest in drug development and regulatory guidelines.
• Fluent in written and spoken English.

Responsabilités

• Write and compile scientific and technical documents related to drug product development.
• Coordinate review and approval activities, ensuring timelines are met.
• Ensure high-quality documentation and discuss potential issues with customers.

Connaissances

Communication

Scientific Writing

Attention to Detail

Problem-Solving

Formation

Master’s degree in Pharmaceutical Sciences

Outils

MS Office

Description du poste

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 Wondelgem (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

For more information about the role, please contact HR.

Email: [e-mail], Tel: [phone].

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.