About this role

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public health through the evaluation and supervision of medicines.

The European Medicines Agency (EMA) operates and develops the Clinical Trials Information System (CTIS) and works with the National Competent Authorities (NCAs) and the European Commission (EC) on the implementation of the Clinical Trial Regulation (EU) No 536/2014 (CTR) including support to the Clinical Trials Coordination Group (CTCG). CTIS is undergoing a process of optimisation. The recent proposals of the Biotech Act (BTA) have accelerated the timelines of this optimisation. The Agency is also working with the 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.
 
The position will involve contributing to the further development and optimisation of CTIS, including in preparation for upcoming regulatory initiatives such as the Biotech Act. Additionally, the position may also require:
•    supporting the design and implementation of activities under the ACT EU programme, in relation to CTIS business intelligence;
•    contributing to communication and change management activities related to CTIS and ACT EU; 
•    providing data analysis and insights to support EMA and the European Medicines Regulatory Network (EMRN);
•    strengthening support to the CTCG and to large multinational clinical trials, including initiatives such as FAST-EU and the pre-CTA consolidated advice process.

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. These activities are especially focused on supporting the oversight as well as contributing to the implementation of the revised CTR by the BTA by advising and supporting the development of the Clinical Trial Information System (CTIS). 

Depending on the specific position, you may:

• interact with different stakeholders (EU member States, European Commission, sponsor representatives, IT providers, EMA legal service) to provide business input in the following CTIS project/programme activities:
  • Analysis & design (AD) session and raise any issues that may arise during the A&D session
  • Review of the functional specifications related to CTIS development
  • Verify business validations (testing of CTIS) and escalate any issues that may arise
  • Support development of CTIS training material as subject matter expert
  • Provide input and testing for AI related enhancements in CTIS;
• provide responses to external queries on CTIS related matters;
• 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.

Link the full role description of the Scientific Officer outlining generic duties and responsibilities.

Apply if you fulfil these eligibility criteria

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:
 
General conditions:
1.    Enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein, or Norway;
2.    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);
3.    Have fulfilled any obligations imposed by applicable laws concerning military service.
 
Specific condition: 
1.    A level of education which corresponds to completed university studies of at least three years in Life Science (e.g. biology, chemistry, biochemistry, pharmacy, medicine), attested by a diploma that must have been obtained by the closing date of this vacancy notice.
 
General Condition 1 and Specific Condition 1 will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failure to present these documents may result in the disqualification from the selection procedure. 
 
Only eligible candidates will be assessed by the Selection Committee.

You will need

Experience

• A minimum of 2 years of experience in the fields of research, development, manufacture, regulation or authorisation of medicines or clinical trials;
• Experience in translating Business requirements into IT Specifications and validating those requirements;
• Experience in information analysis and reporting on scientific/regulatory matters;

Skills & Knowledge

• Excellent Prioritising and Organisational skills;

Competencies you need to have:

Sub-family competencies    
Regulatory frameworks & strategy    Basic
Scientific evidence management    Basic
Scientific product lifecycle and procedure management    Basic
Applied knowledge management    Basic

Grade competencies
Adaptability and agility    Intermediate
Coping with pressures and setbacks    Intermediate
Analysing and problem solving    Intermediate

Core competencies
Ethics and integrity    Intermediate
Team collaboration    Intermediate
Customer centricity    Intermediate
Results orientation    Intermediate
Communication    Intermediate
Cross-cultural sensitivity    Intermediate
Continuous learning and self-development    Basic

For more information about definitions of competencies and associated proficiency levels, please refer to the EMA Competency Framework.

These are considered as Nice to Have

Education

• Masters in a relevant field of study (Medicine or Life sciences);
• Completed PhD or master’s degree in one of the university degrees required for eligibility.

Experience

• In data management and data analysis;
• In testing and validation of AI-enabled solutions or knowledge of Digital/AI enabled systems;
• In regulatory affairs on EU-wide or national procedures or other work on the regulation of medicines;
• In information analysis and reporting on scientific/regulatory matters;
• Clinical experience in a therapeutic field;
• In working for a multinational organisation and managing multiple international stakeholders;
• Nonclinical experience in a Good Laboratory Practice (GLP) laboratory.
• In coordination of research projects;
• In working in a regulatory environment related to the evaluation of medicines or interacting with regulatory agencies;
• In delivering, implementing and using data analytics solutions which include Artificial Intelligence components;
• In data analytics frameworks based on cloud technologies, with tools used in analytics and data visualisation such as R, Python. Power BI or Tableau.
• Using statistical software (for instance R, SAS, etc.) and programming languages used in analytics (for instance SQL, PL-SQL, Python, R, etc.);
• Experience with Data visualisation and usage of  data visualisation tools (for instance Tableau, R Shiny, Oracle BI, Power BI, etc.);
• Knowledge of data collection and practices with data analysis tools;