Medicines and Medical Devices Shortages Specialist

2 maanden geleden


Amsterdam, Noord-Holland, Nederland The European Medicines Agency (EMA) Voltijd
About the Role

We are seeking a highly skilled Medicines and Medical Devices Shortages Specialist to join our team at the European Medicines Agency (EMA). As a key member of our team, you will provide scientific secretarial support to the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), management and support of the Single point of Contact Working Party (SPOC WP) and Industry Single point of Contact (i-SPOC) systems for medicines, and case management of shortages of CAPs and critical shortages.

Key Responsibilities
  • Management of assigned shortage cases, ensuring timely and relevant communication between all stakeholders, with a view to mitigate and manage shortages and ensure availability of product for patients;
  • Discussion of cases escalated to the Medicine Shortages SPOC WP;
  • Identification of shortages/events that could lead to a major event for discussion at the MSSG.
Requirements

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

  • Enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
  • 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);
  • Have fulfilled any obligations imposed by applicable laws concerning military service.

Specific conditions include:

  • Possess a university degree (minimum of three years) in scientific (pharmacy, chemistry, biology or an equivalent) or technical (e.g. applied science) disciplines and at least 3 years of professional experience after obtaining the relevant degree, that must have been obtained by the closing date.
Desirable Skills and Experience

We are looking for candidates with:

  • At least 3 years of experience in the management of shortages, supply chain and manufacturing of medicinal products for human use and/or medical devices, obtained through previous work in academia, industry, notified body, EU competent authority.
  • Experience in interaction with stakeholders such as patients, healthcare professionals, academia, pharmaceutical and/or medical device industry.
Competencies

The successful candidate will possess:

  • Shortage management & availability - Intermediate
  • Regulatory frameworks & strategy - Intermediate
  • Applied knowledge - Intermediate
Working at the EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union, responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use on the EU market. We offer a dynamic and inclusive work environment, with opportunities for professional growth and development.



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