Medicines and Medical Devices Shortages Specialist

Role summary

The European Medicines Agency (EMA) Supply and Availability of Medicines and Devices (TRS SAM) team is looking for a highly motivated professional to join their dynamic and high-impact team. This role offers a unique opportunity to contribute to the availability and supply resilience of medicines and medical devices across the EU, while working closely with senior stakeholders from the European medicines regulatory network, the European Commission, industry, patients and healthcare professionals and international partners.

You will provide scientific and secretariat support to the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), the Executive Steering Group on Shortages of Medical Devices (MDSSG), and the Medicine Shortages Single Point of Contact (SPOC) Working Party. The role involves coordinating key activities, preparing scientific analyses and decision-making materials, facilitating stakeholder collaboration, and supporting the management of medicine shortage and supply issues that can directly impact patient care across Europe.

You will also contribute to the implementation of the new EU pharmaceutical legislation, with a particular focus on the prevention, mitigation, and management of medicine shortages. This includes supporting the identification and management of supply chain vulnerabilities affecting critical medicines, coordinating the management of critical shortage cases and shortages of centrally authorised medicinal products, and helping to develop innovative regulatory approaches to strengthen Europe’s preparedness and ensure continued availability of medicines for patients.

Here is the link to the Role Description of Medicines and Medical Devices Shortages Specialist outlining the generic duties and responsibilities: https://www.ema.europa.eu/en/documents/other/role-description-medicines-medical-devices-shortages-specialist_en.pdf

In this role you will:

• Facilitate the coordination of the implementation of the legal mandate of EMA in the area of availability and security of supply of medicinal products and/or medical devices shortages, in particular with respect to identification of critical medicines (Union list of critical medicines), and evaluation and management of vulnerabilities in the supply chains of those medicines;
• Provide scientific and secretariat support to the MSSG, the MDSSG and their associated Working Parties, Working Groups and subgroups;
• Manage, mitigate and support the prevention of critical shortages;
• Monitor and analyse data on shortages with view to identifying and managing potential or actual shortages of centrally authorised medicinal products.
   

Apply if you meet these eligibility criteria:

General conditions:
1. enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2. have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3. have fulfilled any obligations imposed by applicable laws concerning military service.
 
Specific conditions:
1. possess a university degree (minimum of three years) in : scientific (pharmacy, chemistry, biology or an equivalent) or technical (e.g. applied science) discipline that must have been obtained by the closing date of this vacancy notice,
and 
2. at least 3 years of professional experience after obtaining the relevant degree, that must have been obtained by the closing date of the publication.
 
General Condition 1 and Specific Conditions 1 and 2  will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure. 
Only candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.
 

You will need to have:

Experience

• 3 years from the time when a university degree was awarded on completion of a minimum of three years of study in pharmaceutical supply chain and manufacturing of medicinal products for human use and/or medical devices obtained through working, for example in industry, EU competent authority, notified body, academia

Skills & Knowledge 

• Knowledge of the EU regulatory aspects related to the medicinal product and medical device lifecycle, from research and development, manufacturing to authorisation and post-marketing;

• Strong understanding of pharmaceutical supply chains and their vulnerabilities, including end-to-end knowledge of the production and supply process from raw materials and starting materials, API production, intermediates, formulation, manufacturing, and packaging.

Competencies you will need to have:

Role competencies   

• Shortage management & availability - Intermediate

Sub-family competencies     

• Regulatory frameworks & strategy - Intermediate
• Applied knowledge - Intermediate

Grade competencies      

• Adaptability and agility - Intermediate
• Analysing and problem solving - Intermediate
• Prioritising and organising - Intermediate

Core competencies      

• Ethics and Integrity - Intermediate
• Team collaboration - Intermediate
• Customer centricity - Intermediate
• Results orientation - Intermediate
• Communication    Intermediate
• Cross-cultural sensitivity - Intermediate
• Continuous learning and self-development - Intermediate

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.

These are considered nice to have:

Experience

• In working in a multicultural environment;
• Project management experience in leading, coordination, planning, implementation, evaluation and timely delivery of projects.

Skills & Knowledge 

• A clear understanding of the role of EMA within the legislative framework for the regulation of medicinal products and medical devices.