Serving a population of 500 million citizens, we promote and protect public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective, and of high quality.
We are looking for a Medicines and Medical Devices Shortages Specialist (official job title) to 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 Centrally Authorized Products (CAPs) and critical shortages.
Overview of your role and 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
To be eligible to apply, you will need to:
- Possess a university degree (minimum of three years) in scientific (pharmacy, chemistry, biology or an equivalent) or technical (e.g. applied science) disciplines
- At least 3 years of professional experience after obtaining the relevant degree, that must have been obtained by the closing date
- 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)
- Enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein, or Norway
- Be willing to relocate to the Netherlands
- Have fulfilled any obligations imposed by applicable laws concerning military service
In addition, the following experience and competencies are required:
- 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 industry, academia, notified body, or EU competent authority. This experience can overlap or be in addition to the 3 years of professional experience required for eligibility and listed under the specific conditions.
- Experience in interaction with relevant stakeholders, such as patients, healthcare professionals, academia, pharmaceutical, and/or medical device industry
- Intermediate competency in shortage management & availability as well as regulatory frameworks & strategy
It is a plus to have:
- Experience working in a multicultural environment
- Project management experience in leading, coordination, planning, implementation, evaluation, and timely delivery of projects
- A clear understanding of the role of EMA within the legislative framework for the regulation of medicinal products and medical devices
- Meaningful work contributing to protecting the health of every individual and animal in Europe within a multinational, multidisciplinary team
- Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
- Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)
- Initial 5-year contract with a competitive, tax-free monthly salary of 6,418.36 euros (based on a 40-hour full-time contract) and household & children's allowances (where applicable)
- Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
- Relocation assistance
- Excellent health insurance scheme and social benefits
- Retirement Pension Plan
