Scientific Programme Manager

The team in which you will work, the Pharmaceutical Technology Division (PTD) within the European Pharmacopoeia Department, comprises around 12 colleagues responsible for managing the EDQM’s (ST) database, drafting documentary standards (for the European Pharmacopoeia (Ph. Eur.) and the European Paediatric and European Drug Shortages Formularies) and supporting international harmonisation activities. The Division is in charge of a variety of topics in pharmaceutics, such as dosage forms and respective testing, excipients, packaging materials, pharmacy preparations, manufacturing and nanomedicines. The team works closely with a network of experts.

As a Scientific Programme Manager, you will: 

• co-ordinate and maintain the EDQM’s Standard Terms and pharmaceutical terminology and represent the respective ST Working Party at an international level; support regulatory authorities; ensure alignment with international data standards, in particular: 

• handle all requests for additions to or modifications of the ST database (including dosage forms and routes and methods of administration) and act as the central point of contact for its content, while working in close co-operation with the experts of the ST Working Party;
  
• represent the EDQM in standard terms/terminology matters by participating in the work of the International Organisation for Standardisation (ISO) on the identification of medicinal products (IDMP) and in other meetings organised by ISO, the International Pharmaceutical Regulators Programme (IPRP) and other relevant international working groups.

• develop, co-ordinate and promote documentary standards at an international level, including scientific texts for the Ph. Eur. and possibly the European Paediatric and European Drug Shortages formularies, and ensure their continued relevance in a rapidly evolving regulatory and scientific environment, in particular:
  

• draft texts (monographs and general chapters) in close co-operation with experts in the field on the basis of available scientific information (such as batch data, validation protocols and reports);
• manage the scientific work of the expert groups assigned to you (including planning and co-ordinating activities and following up actions); provide advice to chairs and experts; propose new items for the work programme; evaluate requests for the addition or revision of texts; actively contribute to the drafting of validation or verification protocols for analytical procedures; engage with stakeholders to promote understanding of relevant topics in the field;
• participate in international events or conferences with the aim of promoting the EDQM’s activities;
• participate in strategic reflections aimed at maintaining the Ph. Eur. as the leading pharmacopoeia and at establishing the formularies in Europe and worldwide, in particular by anticipating future standardisation needs in a rapidly evolving environment.

You must:

• hold a higher education degree or qualification equivalent to a master’s degree () in pharmacy, pharmaceutical sciences, or other closely related scientific disciplines;
• have at least 3 years’ recent professional experience in one or more of the following areas:

• assessing medicinal products in a regulatory authority with knowledge of terminology for the classification of dosage forms;
• preparation, production or development of authorised or unlicensed medicinal products in a hospital, research (including PhD studies) or industrial environment, ideally under GMP conditions;
• quality control of medicinal products using relevant testing methods;
• development, verification or validation of manufacturing processes or analytical procedures for medicinal products;
• co-ordination or management of scientific or technical projects in a relevant discipline.

• have a very good knowledge of English, and a basic knowledge of French or the ability to acquire that 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 65 years of age at the closing of the deadline for submission of applications for 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 - Planning and work organisation
• Operational - Analysis and problem solving
• Operational - Drafting skills
• Operational - Results orientation
• Operational - Concern for quality

• Interpersonal - Teamwork and co-operation
• Interpersonal - Adaptability
• Interpersonal - Initiative

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 .

For more information on how we recruit, you can consult the page . This recruitment is carried out in accordance with . 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 .