Junior Scientific Assistant

Job Description

Who we are

With over 2200 staff representing all its 46 member States, the Council of Europe is a multicultural Organisation. We all strive towards protecting human rights, democracy and the rule of law and our three core values - professionalism, integrity and respect - guide the way we work. 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 Council of Europe has its headquarters in Strasbourg (France) and has external presence in more than twenty countries. See here for more information about the Council of Europe external presence.

Your role

As a Junior Scientific Assistant, you will perform a combination of the following tasks for the EDQM’s Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) procedure:

• validating CEP applications as they are received and checking their acceptability for subsequent evaluation (scientific content), in accordance with the rules and guidelines (including the monographs of the European Pharmacopoeia, EU pharmaceutical legislation and guidelines, as well as EDQM specific policies);
• preparing CEPs in accordance with established procedures with a concern for quality;
• helping to process and monitor dossiers and treat notifications; ensuring compliance with applicable systems and working rules;
• providing technical support to the EDQM inspection programme of manufacturers of active substances; gathering data on manufacturing sites; undertaking site status reviews and monitoring GMP (Good Manufacturing Practices) compliance;
• communicating with applicants;
• working in close collaboration with colleagues in the Department for various activities;
• assisting with all activities in accordance with established rules and procedures; reporting to the management on the status and progress of activities when problems occur.

The Junior Professional Programme opens the Council of Europe’s doors to professionals at the start of their career, giving them an opportunity to gain experience working with this pan-European institution. You will benefit from regular working contact with experienced staff, assist senior colleagues in handling their daily work and benefit from the Organisation’s training programme while deepening your knowledge of the Organisation. The length of employment of Junior Professionals is limited to a maximum of four years under this scheme.

What we are looking for

As a minimum you must:

• hold a University degree in pharmacy, chemistry, biochemistry or other relevant discipline (1st cycle of the Bologna process framework of qualifications for the European Higher Education Area);
• have knowledge of at least one of the following areas:
  • - methods of synthesis or analysis of pharmaceutical substances or medicinal products, acquired either at university, in the pharmaceutical industry or in an official medicines control laboratory or similar organisation;
  • - preparation and review of marketing authorisation applications for medicinal products in the pharmaceutical industry (the Common Technical Document (CTD) Module 3 or Active Substance Master Files [ASMFs]);
  • - evaluation of marketing authorisation applications for medicinal products in a licensing authority or similar organisation (CTD Module 3 or ASMFs), due to having participated in this activity;
  • - gathering, analysing scientific data and preparing quality data relevant to marketing authorisation applications (CTD Module 3 or ASMFs) for submission to competent authorities, including experience in ensuring compliance with regulations when preparing submissions;
• Relevant professional experience in these areas is highly desirable, but this must not exceed 12 months.
• 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);
• be a citizen of one of the 46 member States of the Council of Europe;
• be under 32 years of age at the closing date of the vacancy notice.

What we offer

If successful, you may be offered employment based on renewable fixed-term contracts for a maximum cumulated duration of four years at grade B3. This salary may be supplemented by other allowances depending on your personal situation and you will be affiliated to a Council of Europe pension scheme. You will also benefit from private medical insurance, 32 working days leave per year and other benefits (including flexible working hours, training and development, possibility of teleworking, etc.).

Applications and selection procedure

Deadline for applications is 06 October 2022 (midnight French time). Applications must be made in English or French using the Council of Europe online application system. By connecting to our www.coe.int/jobs you can create and submit your online application. Please fill out the online application form providing all requested details and explain how your competencies make you the best candidate for this role. It usually takes a few hours to fill in an application form, so please take this information into consideration while applying.