Junior Scientific Assistant - CEP procedure

The mission of the ) is to contribute to public health protection by engaging with an international community of experts and stakeholders. We achieve this by promoting access to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific benchmark worldwide. The EDQM's standards for medicines and their ingredients, compiled in the European Pharmacopoeia, are legally binding in 39 member states of the Council of Europe 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.

You will work in the Certification of Substance Department (DCEP), which is responsible for the Certification procedure of suitability to the monographs of the European Pharmacopoeia (CEP). Within the DCEP, the Scientific Support and Inspection Division takes charge of scientific and administrative support to the CEP procedure. The division is composed of 23 scientists and administrative assistants from various backgrounds.

As a Junior Scientific Assistant, you will:

• prepare Certifications of suitability to the monographs of the European Pharmacopoeia (CEPs) in accordance with established procedures and with a concern for quality;
• help to process and monitor dossiers and treat notifications; ensure compliance with applicable systems (including the monographs of the European Pharmacopoeia, EU and EDQM guidelines and EDQM internal working rules);
• provide technical support to the evaluation and inspection processes (request information, compile and analyse scientific data, etc.);
• communicate with applicants;
• work in close collaboration with colleagues from across the department on different activities;
• report to the management on the status and progress of activities.

You must: 

• have a higher education degree or qualification equivalent to the 2nd cycle of the in pharmacy, chemistry, biochemistry or other relevant discipline;
•  have knowledge of at least one of the following topics:
  • 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 (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); or
  • 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 it must not exceed 2 years in total. 

• have very good knowledge of English (one of the two official languages of the Council of Europe) and basic knowledge of French (other official language).

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 35 years of age at the closing date of this vacancy notice.

Your application must demonstrate to what extent you have the competencies listed below. To help you doing so, feel free to consult our .

• Operational - Professional and technical expertise
• Operational - Planning and work organisation
• Operational - Analysis and problem solving
• Operational - Concern for quality
• Interpersonal - Service orientation

• Operational - Learning and development
• Interpersonal - Teamwork and co-operation
• Interpersonal - Adaptability

This job vacancy is published within the framework of the Junior Professional Programmes (limited to 4 years). You can consult the conditions of employment (salaries, allowances, pension scheme, social insurance, etc.) on the webpage .

For more information on how we recruit, you can consult the page . This recruitment is carried out in accordance with Articles 490 and 4100 of the Council of Europe Staff Rules. The deadline for applications is indicated in the General information section of this vacancy notice (see above) and is fixed at 23:59:59 (CET/CEST). When applying, make sure your motivation shows how your competencies make your profile the best for the role.

As an equal opportunity employer, the Council of Europe welcomes applications from all suitably qualified people, irrespective of sex, gender, sexual orientation, ethnic or social origin, disability, religion or belief. Under its equal opportunity policy, the Council of Europe is aiming to achieve gender parity in staff employed in each category and grade. At the time of appointment, preference between suitable people shall be given to the person of the gender which is under-represented in the relevant grades within the category to which the vacancy belongs.

Applicants with specific needs are encouraged to request reasonable accommodations at any stage during the recruitment process. Please contact us at , we will ensure that your request is handled.

The information published on the CoE’s careers website regarding working conditions is correct at the time of publication of the vacancy notice. Any changes to these conditions during the recruitment process will be updated on our Portal and will apply at the time of the job offer. Our career's website is not intended to be exhaustive and may not address all questions you would have. Should you have remaining questions, please contact us at .