Scientific Programme Manager, Strasbourg

Your Team

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 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 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 a committed team of approximately 60 professionals - encompassing scientists, regulatory experts, project managers and administrative staff with a diversity of backgrounds and expertise. DCEP is at the heart of the EDQM\u2019s mission to protect public health by delivering robust, high-quality scientific assessments, ensuring implementation of the procedure for Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) and conducting GMP (Good Manufacturing Practice) inspections of active substance manufacturers. Working in close collaboration with other EDQM departments and an extended international network of stakeholders, DCEP promotes a culture of co-operation, high performance and continuous improvement in support of safe medicines across Europe and beyond.

Your Role

As a Scientific Programme Manager in DCEP, you will contribute to activities related to the Certification procedure as one of the following profiles:

Profile 1 - Assessor: your role will mainly involve assessing applications to Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) and ensuring that the regulatory requirements relating to pharmaceutical substances are respected, in particular by:

• participating in the scientific evaluation of CEP applications in accordance with the applicable rules and guidelines (including European Pharmacopoeia monographs, EU legislation and guidelines, and EDQM-specific guidelines);
• working in collaboration with expert assessors from national competent authorities; preparing reports and taking part in scientific discussions with external experts or advisory committees with the aim of reaching consensus;
• communicating with CEP applicants to obtain additional information and clarify issues with their dossiers;
• ensuring appropriate monitoring of assigned dossiers according to established timelines.

  Profile 2 - GMP Inspector: your role will mainly involve performing GMP inspections of manufacturers of active substances involved in the CEP procedure by:

  • regularly preparing and carrying out on-site inspections of manufacturing facilities (primarily in Asia), together with GMP inspectors from competent authorities, to assess compliance with GMP and relevant CEP applications;
  • collaborating with inspectors from national supervisory authorities and other international organisations; preparing inspection reports;
  • communicating with manufacturers on inspection findings; advising on necessary actions in the event of a public health risk;
  • following up on actions, including evaluating the corrective actions implemented by manufacturers to address deficiencies identified during inspections; monitoring progress and actions according to established timelines.

    Profile 3 - Regulatory Professional: your role will mainly involve supporting the evaluation of CEP applications, the GMP inspection programme and the implementation of new or revised guidelines by:

    • participating in scientific investigations regarding CEP applications in accordance with the applicable rules and guidelines (including European Pharmacopoeia monographs, EU pharmaceutical legislation and guidelines, and EDQM-specific guidelines);
    • evaluating the impact of new or revised regulatory requirements (such as from the ICH and the EU) for CEP-related activities; preparing or participating in the elaboration or revision of scientific and operational documents, such as guidelines, FAQs and information for the EDQM website;
    • working in close collaboration with colleagues within the EDQM and external experts;
    • communicating with CEP applicants to obtain additional information and clarify issues with their dossiers.

      Requirements to apply

      You must:

      • have the support of the member State seconding you to the Council of Europe;
      • have a higher education degree or qualification equivalent to a master\u2019s degree (2nd cycle of the Bologna process framework of qualifications for the European Higher Education Area), in pharmacy, chemistry, biochemistry, engineering or other relevant discipline;
      • have very good knowledge of English and a basic knowledge of French or the capacity to learn it on the job;
      • be a citizen of one of the member States of the Council of Europe.

        Profile 1 - Assessor:

        • have at least 3 years' professional experience, including 2 years\u2019 relevant professional experience in the evaluation or compilation of the quality part of dossiers submitted with marketing authorisation applications for medicines (with a focus on Module 3.2.S of the CTD), either in a national competent authority or in the pharmaceutical or chemical industry;

          Profile 2 \u2013 GMP Inspector:

          • have at least 3 years' professional experience, including 2 years\u2019 experience as an official GMP inspector obtained either in a national authority or analogous international organisation;

            Profile 3 \u2013 Regulatory Professional:

            • have at least 3 years' professional experience, including 2 years\u2019 relevant professional experience in the evaluation or compilation of the quality part of dossiers submitted with marketing authorisation applications for medicines, either in a national competent authority or in the pharmaceutical or chemical industry, or 2 years\u2019 relevant experience in policy analysis or international affairs in the area of medicines.

              Key competencies

              • Operational - Professional and technical expertise
              • Operational - Planning and work organisation
              • Operational - Results orientation
              • Interpersonal - Relationship building

                What we offer

                This vacancy is for a secondment, ruled by Article 23 of Committee of Ministers\u2019 Resolution CM/Res(2012)2 . You can consult the conditions of secondment to the Council of Europe (days of leave, allowances etc.) on the webpage What we offer . This secondment foresees the relocation allowance and the travel expenses from the Organisation as indicated in Article 23 of the Resolution.

                This secondment should start as soon as possible.

                Applications and selection procedure

                For more information on how we recruit, you can consult the page Our recruitment process of our Career's website. 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). Only applicants who meet the conditions of the Committee of Ministers\u2019 Resolution CM/Res(2012)2) and who best meet the abovementioned criteria will be considered for selection and for the next stage.

                Important information

                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 Voir email sur uncareer.net, we will ensure that your request is handled.

                The information published on the CoE\u2019s 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 Voir email sur uncareer.net.