SNE/Medicines and Medical Devices Shortages Specialist

About this position:

The European Medicines Agency (‘the Agency’) is a decentralised body of the European Union based in Amsterdam, The Netherlands. Its core responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines. There is currently an opportunity for a Seconded National Expert to work in the Supply and Availability of Medicines and Devices  Division, providing scientific secretarial support to the MSG and/or MDSG, management and support of the EU SPOC and i-SPOC systems for medicines and/or medical devices, and case management of shortages of CAPs.

We are looking for a specialist in availability of medicines, including shortage management, and security of supply of medicines. As a specialist in this area you will be providing technical and scientific support to the activities of the Agency, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and the Medicines Shortages Single Point Of Contact Working Party (SPOC WP).

The scope of the activities include preparedness and response activities relating to the availability of medicinal products for human and veterinary use, irrespective of the licensing route (centralised, national). The focus is on maintaining the continuous availability of authorised medicines and strengthening the resilience of supply chains. This work will further expand under the proposed pharmaceutical legislation with TRS-SAM providing analytical and operational support to the MSSG and the SPOC Working Party in preparation for, and during, implementation of the new legislation.

In this role you will:

As a Seconded National Expert with experience relevant to in availability of medicines, including shortage management, and security of supply of medicines, you will perform duties as following: 

• Facilitate the coordination of the current and new legal mandate of EMA in the area of prevention, monitoring, and management of medicinal products and medical devices shortages, and on strengthening the security of supply of critical medicines.
• Support the implementation of the relevant provisions of the new pharmaceutical legislation and the forthcoming Critical Medicines Act.
• Provide scientific, technical and secretarial support to the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and/or the Executive Steering Group on medical devices (MDSSG).
• Manage and support the EU Medicines Regulatory Network and industry network of single point of contacts (SPOC WP and i-SPOC), facilitating structured data exchange and monitoring and analysing shortage notifications to identify, prevent and manage potential or actual shortages of medicinal products.
• Support the operation of the Voluntary Solidarity Mechanism (VSM) and ensure effective coordination among national and EU/EEA stakeholders.
• Contribute to the establishment and regular review of the Union list of critical medicines.
• Coordinate and support the work on shortage prevention plans and shortage mitigation plans, including the deployment and continuous refinement of the vulnerability assessment methodology.
• Monitor events that could lead to a major event or a public health emergency and could disrupt the supply of medicinal products and/or medical devices.
• Support data collection and analysis on crisis-specific critical medicinal products and/or medical devices, including demand and supply assessments in collaboration with National Competent Authorities (NCAs) through the SPOC WP and industry stakeholders.
• Support the MSSG’s recommendations by providing analytical support for matching demand and supply data and identifying appropriate preventive or mitigating measures.
• Provide support to the development of guidance and best practices for stakeholders.

Apply if you meet these eligibility requirements:

• You are national of an EU or EFTA Member State or a candidate country as decided by the Council;
• You have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (B2 level);
• You are currently  employed in the public sector (such as a university, research institute, public hospital or regulatory body) in a European Union (EU) Member State, the European Free Trade Area (EFTA), candidate countries and public intergovernmental organisations (IGOs).
   

You will also need to have:

Education

• A University degree in scientific (pharmacy, chemistry, biology or an equivalent) or technical (e.g. applied science) discipline that must have been obtained by the closing date.

Experience

• At least 3 years from the time when a university degree was awarded on completion of a minimum of three years of study;
• Experience in shortage management, supply chain and manufacturing of medicinal products for human use and/or medical devices. 
• Experience of interaction with stakeholders such as patients (organisations), healthcare professionals (organisations), academia, pharmaceutical and/or medical device industry.

Skills & Knowledge 

• Knowledge of the current and planned EU regulatory aspects related to the medicinal product and medical device lifecycle, from research and development, manufacturing to authorisation and post-marketing.
• Strong analytical and problem-solving skills, with the ability to interpret and integrate complex quantitative and qualitative data to inform evidence-based decisions and recommendations.
  
   

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.
• Good organisational and planning skills with the ability to work to demanding deadlines;
• Ability to summarise and communicate clearly complex information to both expert and non-expert audiences;
• Proactive, can-do approach with effective problem-solving skills;
• A team-player, willing to support colleagues across the whole team.