Medicines and Medical Devices Shortages Specialist
Support secretariat of the Executive Steering Group on Shortages and Safety of Medicinal Products and/or the Executive Steering Group on medical devices;
Monitor any events which may lead to a major event or a public health emergency, and which may affect the supply of medicinal products and/or medical devices;
Manage and support the EU network and industry network of single point of contacts (SPOC Network and i-SPOC), and monitor and analyse the data on shortages with view to identifying any potential or actual shortages and forecast of medicinal products and/or medical devices;
Support the establishment of list of critical medicinal products and/or medical devices, collect demand data for a specific list of medicines and/or medical devices from all National Competent Authorities (NCAs) through the EU network of single point of contacts;
To review, analyse and aggregate the data submitted from NCA SPOCs, and to estimate demand in EU/EEA countries to support the Steering Group on the draft of recommendations on any measures to prevent or mitigate potential or actual shortages
Coordinate collection of information on mitigation plans including production and supply capacity from industry;
Liaise with relevant stakeholders, including international partners, WHO and learned societies (e.g. ESICM)
To be eligible for consideration for this position, you are required to:
enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway; possess a university degree of a minimum of three years in life sciences (pharmacy, chemistry, biology or an equivalent) or a scientific degree related to medical devices discipline, that must have been obtained by the closing date of this vacancy notice; have at least 3 years of relevant professional experience after obtaining the relevant degree and before the closing date of this vacancy notice; 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.
For criteria 1, 2 and 3, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.
Proven professional experience of at least 3 years in 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;
Demonstrable 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;
Experience of interaction with stakeholders such as patients, healthcare professionals, academia, pharmaceutical and/or medical device industry.
Proven experience in working in a multicultural environment;
A clear understanding of the role of EMA within the legislative framework for the regulation of medicinal products and medical devices;
Project management experience in leading, coordination, planning, implementation, evaluation and timely delivery of projects.