Scientific Writer role focusing on CMC Drug Product development at Ardena. Collaborate on scientific documents and ensure regulatory compliance in a hybrid working setup.
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.
Requirements
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.
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.
Benefits
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.
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