Temporary Scientific Assistant B3/B4

Grade: B3

Salary: around 4200€ per month (gross)

Contract Type: Temporary (12 months max)

Location: Strasbourg (France)

Do you have chemical synthesis, regulatory or analytical chemistry skills? Do you have a passion for scientific evaluation and compliance? The Certification of Substances Department (DCEP), in charge of the Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) is looking for a junior scientific assistant to join a dynamic team in Strasbourg.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a leading organisation whose mission is to contribute to the protection of public health by promoting access to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific benchmark worldwide. These standards for medicines and their ingredients are compiled in the European Pharmacopoeia and are legally binding in 39 European member States (and the European Union) but are widely used in the human and animal health sectors across the globe. The EDQM also develops guidance and standards in the areas of blood transfusion, organ, tissue and cell transplantation and consumer health issues such as cosmetics and food contact materials. Watch our video for more information.

The Certification of Substances Department (DCEP) is responsible for implementing the procedure for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP). The CEP procedure is one of three alternative options to demonstrate in a marketing authorisation application for a medicine that the quality of the active pharmaceutical ingredient(s) included in it is suitably controlled by the respective European Pharmacopoeia monographs and complies with regulatory requirements. As part of the CEP procedure, the EDQM conducts risk-based GMP inspections of manufacturing sites covered by CEPs.

As a scientific assistant in DCEP you would perform a combination of the following tasks:

• undertaking scientific evaluation of requests for CEP revisions in accordance with technical rules and guidelines (general and specific monographs of the European Pharmacopoeia, ICH, EU guidelines and guidelines adopted by the Certification Steering Committee);
• participating in monitoring of dossiers and ensuring compliance with applicable systems and working rules;
• 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 when problems occur.

We are looking for candidates with the following:

• a higher education degree or qualification in a relevant area (for example: pharmacy, chemistry, biochemistry, food science);
• relevant professional experience in at least one of the following areas:
• o 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;
• o 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;
• o 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 one of the two official languages of the Council of Europe (English) and basic knowledge of the other (French).

You must also:

• be a citizen of one of the 46 member states of the Council of Europe
• be under 65 years of age at the closing date of this job announcement.

What we offer:

• practical experience in scientific assessment of quality data (post-approval changes);
• an opportunity to work in a leading international organisation in the field of public health protection, contributing to delivering high quality medicines and healthcare in Europe and beyond;

Other benefits

Please note that the duty station for this position is Strasbourg (France).

If you meet the requirements and are a national of one of the 46 member states , please submit your application by email at [email protected] as soon as possible.

To get more information about this temporary position please contact [email protected]