Scientific Assistant

Job Description
Grade: B4
Salary: €4 442 per month (gross)
Location: Strasbourg (France)
Reference: Vacancy Notice n° e9/2023
Deadline for applications: 01/06/2023

Would you like to build a career in regulatory affairs? Do you have excellent chemical synthesis or analytical chemistry skills? Do you have the scientific expertise required to check the acceptability of applications for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) on receipt, to critically review data according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), European Union (EU) and EDQM guidelines, to prepare evaluation reports or provide technical support to the assessment activities and the EDQM inspection programme of manufacturers of active substances? Then why not give your career a boost by joining our CEP team in Strasbourg? This job offer may be the right opportunity for you.

Scientific assistants in The Certification of Substances Department (DCEP) 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 Steering Committee of the Certification procedure)
• Participating in the monitoring of dossiers, treating notifications, and ensuring compliance with applicable systems and working rules
• Contributing to the validation of CEP applications on receipt, checking their acceptability (format and 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) 
• Gathering and analysing scientific data and preparing reports for review; preparing data and participating in decision-making processes; monitoring applications and preparing CEPs
• Providing technical support to the EDQM inspection programme of manufacturers of active substances; gathering data on manufacturing sites and ensuring the links between evaluation and inspection activities
• 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.

What we offer:

• International Working Environment
• Flexible Working/ Teleworking
• Private Health Insurance
• Holidays, well-being and work-life balance
• Sustainable working environment
• Attractive tax-free salary.

Let’s work together for better health, for all!

If you meet the eligibility criteria and are a citizen of one of the 46 member States of the Council of Europe, please submit your application using our online recruitment website and click here to find out why you should join
the EDQM.

For more information on how to apply, please click on the 'Apply Now' button.

CoE EDQM:
With over 2000 staff representing all its 47 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 scientific benchmarks 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 guidelines 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. Within the EDQM, the European Pharmacopoeia Department (EPD) is responsible for the technical and scientific Secretariat of the European Pharmacopoeia (Ph. Eur.) Commission and for preparing the texts of the Ph. Eur. with the relevant groups of experts and working parties. The purpose of a pharmacopoeia is to promote public health by the provision of recognised common standards for the quality of medicines and their components. The Ph. Eur. thus plays a key role in ensuring that medicines in Europe are safe and of good quality. To elaborate on the Ph. Eur., EPD works with a network of more than 800 experts with an extensive scientific background in different disciplines from all over Europe and beyond.