Senior Medicines and Medical Devices Shortages Specialist

About this position:

The Supply and Availability of Medicines and Devices Office (TRS-SAM) is seeking a Senior Medicines and Medical Devices Shortages Specialist to help ensure the secure and continuous supply of medicines and medical devices across Europe.

This is a great opportunity for a senior professional with strong expertise in the European legal framework for medicines, including current and upcoming EU legislation, as well as relevant national and global developments. A solid understanding of medicine supply chains and proven experience engaging with supply chain stakeholders are essential.

In this role, you will contribute to strengthening supply resilience, preventing shortages, and supporting public health at EU level. 

If you are passionate about public health, regulatory excellence, and the importance of strengthening the supply of medicine, we invite you to join us in making a tangible difference.

In this job you will:

• Manage shortage and supply chain related discussions with stakeholders; 
• Lead discussions on implementation of new pharma legislation in the area of shortages and security of supply;
• Interact with international partners e.g. bilateral and multilateral shortage and security of supply-related activities with international regulatory counterparts;
• Support policy development relating to shortage prevention plans and their implementation across the EU; 
• Inform and keep up to date strategies to identify vulnerabilities in the supply chains of critical medicines to inform appropriate solutions to ensure their secure and continued supply;
• Provide scientific secretariat to the Executive Steering Group on Shortages and Safety of Medicinal Products.

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Here is the link to the Role Description of Senior Medicines and Medical Devices Shortages Specialist outlining generic duties and responsibilities:

Medicines and Medical Devices Shortages Senior Specialist

Apply if you meet these eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions: 

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. 

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Specific conditions: 

1.    possess a university degree (minimum of four years) in  the field of of Sciences (e.g. biology, chemistry, biochemistry, pharmacy, medicine, engineering, pharmaceutical management, pharmaceutical supply chain management) that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties. 

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2.   possess a university degree (minimun of three years) in the field of of Sciences (e.g. biology, chemistry, biochemistry, pharmacy, medicine, engineering, pharmaceutical management, pharmaceutical supply chain management) that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ relevant professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.  

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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.

You will also need to have:

Experience

• In-depth understanding of pharmaceutical and medical device supply chains, from raw materials and APIs to finished products and distribution;
• Project management experience in leading, coordination, planning, implementation, evaluation and timely delivery of projects.
• Experience to engage constructively with a wide range of stakeholders, including MAHs, manufacturers, wholesalers and patient representatives;
• Experience in identification and management of issues that may impact security of supply of medicines.
• Experience in monitoring stock levels and forecast demand to prevent shortages.

Skills & Knowledge 

• Knowledge of logistics/distribution, regulatory requirements for imports/exports and contingency plans for supply disruptions.
• 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.

Competencies you will need to have:

Role competencies 

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• Pharmaceutical quality – Basic
• Scientific product lifecycle and procedure management - Intermediate  
• Shortage management &availability - Advanced

Sub-family competencies 

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• Regulatory Framework and Strategy - Intermediate
• Applied knowledge - Advanced 

Grade competencies

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• Adaptability and agility – Intermediate
• Coping with pressures and setbacks – Advanced  
• Analysing and problem solving – Advanced 

Core competencies 

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

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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.

Skills & Knowledge 

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