Scientific assistant

Grade: B4                                                                                  

Location: Strasbourg (France)                                           

Reference: Vacancy Notice n° e1039/2025 

Deadline for applications: 02/10/2025

Apply here

Vacancy notice on the CoE talents website; here

Your Team

The European Directorate for the Quality of Medicines & Healthcare (EDQM) is a leading organisation whose mission is to contribute to public health protection by engaging with an international community of experts and stakeholders. We achieve this by promoting acces to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific bookmark worldwide. The EDQM's standards for medicines and their ingredients, compiled in the European Pharmacopeia, are legally binding in its 39 member states (and the European Union) and are also widely used across the globe in the human and animal health sectors. The EDQM also plays a crucial role in the areas of blood transfusion, organ, tissue and cell transplantation and in developing and setting consumer health standards, such as for cosmetics and food contact materials.

The Certification of Substances Department (DCEP) is responsible for the Certification procedure for suitability with the European Pharmacopoeia monographs (CEP procedure). Within the DCEP, the Evaluation Division takes charge of the scientific assessment of CEP applications and their revisions. The Division is composed of 35 scientists from multiple backgrounds split into four teams, and it works with a network of about 80 quality assessors nominated by national competent authorities.

Your Role

Scientific assistants in the Certification of Substances Department (DCEP) perform all or part of the following tasks: 

• participating in the activities of the DCEP, in particular:
  • undertaking the scientific evaluation of CEP revision requests in accordance with technical rules and guidelines (general and specific monographs of the European Pharmacopoeia, guidelines adopted by the Steering Committee of the Certification procedure, ICH guidelines and EU explanatory notes);
  • contributing to the validation of CEP applications on receipt, checking their acceptability (format and content) in accordance with the rules and guidelines in force (including the monographs of the European Pharmacopoeia, EU pharmaceutical legislation and guidelines, as well as EDQM-specific policies);
  • gathering and analysing scientific data and preparing reports for review; preparing data and participating in decision-making processes; monitoring applications and preparing CEPs;
• managing all activities in accordance with established rules and procedures; communicating regularly with companies; reporting to the management on the status and progress of activities and notify them of any problems.

Requirements to apply

You must:

• have higher education degree or qualification equivalent to a master’s degree (2nd cycle of the Bologna process framework of qualifications for the European Higher Education Area) in pharmacy, chemistry, biochemistry, food science, or any other relevant field;
• have at least one year of relevant professional experience acquired in at least one of the following areas:
  • methods of synthesis or physicochemical analysis of pharmaceutical substances or medicinal products, acquired either in the pharmaceutical industry, an official medicines control laboratory or a similar organisation, or acquired during PhD studies in a relevant field;
  • scientific evaluation of marketing authorisation applications of medicinal products with a focus on the Common Technical Document (CTD) Module 3 or Active Substance Master Files (ASMFs) in a licensing authority;
  • gathering, analysing scientific data and reporting on quality data relevant to marketing authorisation applications (CTD Module 3 or ASMFs) for submission to competent authorities including experience in ensuring compliance with regulations during the preparation of submissions;
• have a very good knowledge of English and basic knowledge of French or capacity to acquire the knowledge on the job.

You must also:

• be a citizen of one of the member states of the Council of Europe and fulfil the conditions for appointment to the civil service of that state;
• have discharged any obligation concerning national service (military, civil or comparable);
• not be the parent, child, stepchild or grandchild of a serving staff member of the Council of Europe;
• be under the age of 65 years.