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Scientific Specialist
2 maanden geleden
The European Medicines Agency (EMA) is seeking a highly skilled Scientific Specialist to join its team. As a key member of the Labelling Office, you will play a crucial role in ensuring the accuracy and consistency of product information for medicinal products across the EU.
Key Responsibilities- Manage the labelling review and standards check of product information for new applications, line-extensions, and renewals.
- Support the SmPC Advisory Group activities, including drafting advice on the interpretation of the SmPC guideline.
- Prepare and participate in QRD and NRG plenary meetings.
- Provide scientific coordination and regulatory support in relation to medicinal product life-cycle management.
- Apply EU pharmaceutical legislation to the operations of the Agency.
- A level of education which corresponds to completed university studies of at least three years attested by a diploma.
- Life Science background (e.g. biology, chemistry, biochemistry, pharmacy, medicine).
- 3 years of experience in medicinal product life-cycle management, with a focus on product information review.
- Sound knowledge of the regulatory and legal framework applicable to the work of the Labelling Office.
- Organisational skills.
- Communication skills.
- Critical review and drafting of scientific and regulatory documents.
- Presenting scientific or regulatory matters.
- Proficient in English language.
- Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU.
The EMA is a decentralised body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. As a Scientific Specialist, you will be part of a dynamic team working to protect and promote public health through the evaluation and supervision of medicines.
We are looking for a highly skilled and motivated individual to join our team. If you have a strong background in life sciences and experience in medicinal product life-cycle management, we encourage you to apply for this exciting opportunity.
