Scientific Assistant

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.

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.

Before applying to this vacancy notice, note that special conditions apply to this profile. Please read this document.

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.

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

• Operational - Planning and work organisation
• Operational - Analysis and problem solving
• Operational - Concern for quality
• Interpersonal - Service orientation
• Interpersonal - Teamwork and co-operation

• Professional and technical expertise:

• knowledge of the European regulatory requirements in the field of pharmaceuticals;
• sound computer skills enabling to use common office applications.

• Interpersonal - Communication
• Interpersonal - Adaptability

This job vacancy is for an international external recruitment. You can consult the conditions of employment (salaries, allowances, pension scheme, social insurance, etc.) on the webpage What we offer. 

For more information on how we recruit, you can consult the page Our recruitment process. This recruitment is carried out in accordance with Article 490 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 talents@coe.int, 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 talents@coe.int.