About this position:

The Agency is looking to strengthen the support it provides to clinical trials through the secondment of national experts for a period of one to two years (renewable). The Agency is working with the National Competent Authorities (NCAs) for medicines and the European Commission to optimise the EU clinical trials environment and this is being coordinated through Accelerating Clinical Trials in the EU (ACT EU) the EU transformation programme for clinical trials. EMA also operates and develops the Clinical Trials Information System (CTIS) and works with the NCAs and the Commission on the implementation of the Clinical Trials Regulation (CTR) including support to the Clinical Trials Coordination Group (CTCG).

Depending on the specific role, the position may involve:

• strengthening support to the CTCG and to large multinational clinical trials, including initiatives such as FAST-EU and the pre-CTA consolidated advice process;
• contributing to the further development and optimisation of CTIS, including in preparation for upcoming regulatory initiatives such as the Biotech Act;
• supporting the design and implementation of activities under the ACT EU programme;
• contributing to communication and change management activities related to ACT EU and CTIS; and
• providing data analysis and insights to support EMA and the European Medicines Regulatory Network (EMRN).

In this role you will:

Working within the EMA Data Analytics and Methods Task Force you will be part of multidisciplinary teams at EMA and across the National Competent Authorities and European Commission. You will contribute to strengthening and transforming the European clinical trials environment, supporting key regulatory, scientific, and operational activities.

Depending on the specific position, you may:

• support the day-to-day activities of the CTCG, including coordination and facilitation of collaborative procedures such as FAST-EU and the pre-CTA consolidated advice process to support multinational clinical trials;
• contribute to the development and optimisation of CTIS, working with the clinical trials teams to define business requirements for new system functionalities introduced by the Biotech Act;
• participate in the implementation of ACT EU initiatives, including cross-network projects and strategic actions aimed at improving the EU clinical trials landscape;
• support communication, stakeholder engagement, and change management activities to promote effective use of CTIS, the upcoming implementation of the Biotech Act and broader ACT EU initiatives;
• conduct data analysis to inform stakeholder needs and support decision-making across EMA and the EMRN.

Apply if you meet these eligibility criteria:

1. Enjoy full rights as a citizen of an EU Member State, Iceland, Lichtenstein, Norway, Republic of Moldova or Ukraine;
2. Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the EU (at least level B2);
3. Are currently employed in the public sector (such as a public intergovernmental organisation (IGO) national / regional /local public administration) in an EU Member State and are due to remain in such employment for the foreseen duration of the SNE position. ross EMA and the EMRN.

Essential requirements

Education

• A level of education which corresponds to completed university studies of at least three years attested by a diploma;

Field of study
Life Science (e.g. biology, chemistry, biochemistry, pharmacy).
Experience

• 3 years from the time when a university degree was awarded on completion of a minimum of three years of study;
• Experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry, national ethics body or in a healthcare / academic setting should have been obtained in:
  • The scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines
  • Working with medicinal products containing medical devices and associated regulatory framework.

Skills & Knowledge

• Organisational skills
• Communication skills
• Critical review and drafting of scientific and regulatory documents for experts and lay audiences
• Presenting scientific or regulatory matters at high level
• Proficient in English language
• Proficient in Ms office suite
• Knowledge and understanding of The EU pharmaceutical legislation on the regulatory framework for pharmaceutical products in the EU.

These are considered as nice to have:

Education

• Masters in a relevant field of study (Medicine or Life sciences);
• Master’s degree in regulatory science and/or affairs.

Field of study

• Scientific background relevant to perform the role.

Experience

• In information analysis and reporting on scientific/regulatory matters;
• Clinical experience in a therapeutic field;
• Pharmaceutical development experience;
• With medicines assessment at a National Competent Authority;
• Regulatory scientists/product manager experience;
• Knowledge of data collection and practices with data analysis tools;
• Knowledge of training others in interpreting and using analytics;
• In delivering, implementing and using data analytics solutions which include Artificial Intelligence components;
• Experience in the preparation and/or review of any part of a clinical trial application dossier or scientific advice application;
• Experience in working with stakeholders (industry and national/international authorities)