Trainee (Change management linked to the use of clinical study data in medicine evaluation)

Job title:

Trainee (Change management linked to the use of clinical study data in medicine evaluation)

Company:

European Medicines Agency

Job description

Selection procedure reference: EMA/TR/10932Deadline for applications: 6 May 2025 23:59 CETThe European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It began operating in 1995. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.This traineeship opportunity is now open for applications until 6 May 2025 23:59 CET, with an intake on 1 October 2025.About the traineeship programmeThe Agency is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme or PhD students or Master’s students (who posses a previous degree), who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly in the interest of the trainee’s training and principally serve to increase the trainee’s knowledge and to gain relevant experience.Placement descriptionWe are looking for a trainee in the Data Analytics and Methods Task Force.Specific objectives and projectsDuring the traineeship, the trainee will work on projects to support the transformation of the European Medicines Regulatory Network (EMRN) to a more data-driven regulatory network. The trainee will be involved in the development and implementation of change management activities (eg., trainings, communication, review of guidance and requirements…) on the use of clinical study data (individual patient data in electronic strucutured format) to support medicine evaluation.This will include strengthening of the support to EMRN in terms of implementing the use of clinical study data in the regulatory assessment and regularly liaising with a wide range of stakeholders including different EMA functions, national competent authorities, members of the Agency’s scientific Committees and Working Parties members, but also international regulatory agencies.Learning outcomesThe learning outcomes will be1. Understanding of how the access and use of clinical study data can support medicine evaluation
2. Development and application of effective change management strategies in a complex regulatory environment
3. Understanding the operations of the European Medicines Regulatory Network and its stakeholders, including other international regulatory agencies (e.g. US FDA, Japan PMDA)
4. Working in an interdisciplinary project team, contributing to its objectives through individual tasks and collaboration
5. Working in a stimulating and international environmentEligibility criteriaTo be eligible for consideration for this placement, you are required to: * enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;

• possess a university degree in business, change management, communication and policy linked to innovations (minimum of three years or more) that must have been obtained between 6 May 2024 and 6 May 2025 or be a university student on an Erasmus + or a similar programme or a PhD student or a Master’s student with a previous fully finished degree in the areas mentioned before.
• a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2) of the

For criteria 1 and 2, 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 procedure.Additional skills

• A university degree in biostatistics/epidemiology, data science or medicine/pharmacy could also match if the candidate has also good communication skills.
• Experience in international environments and networks, communication
• Knowledge of Agile methodology

Behavioural CompetenciesYou will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills
• Working with others
• Adaptability
• Research and analytical skills

Expected selection timelinesDeadline for applications 6 May 2025 23:59 CET
Assessments (remote) From end of June 2025 to mid-July 2025
Decision and offers By end of July 2025
Placement start 1 October 2025Conditions of traineeshipThe traineeship is offered for 10 months (1 October 2025 – 31 July 2026) and takes place at the Agency’s premises in Amsterdam with possibility for teleworking up to 40% of working time from The Netherlands and occasional teleworking from outside The Netherlands. Traineeships are offered for either full-time or part-time (80% or 50%) if combined with university studies.The Agency pays a monthly stipend of €1,942.19 for a full-time traineeship (reduced accordingly for 80% or 50%) and a travel contribution upon joining the Agency.Each trainee will have a mentor at the Agency who will guide the trainee through the programme.The conditions of employment are stated in the Executive Decision on rules governing the traineeship programme at the EMA available .Domenico Scarlattilaan 6 – 1083 HS Amsterdam – The NetherlandsTelephone +31 (0)88 781 6000 – Email© European Medicines Agency, 2024. Reproduction is authorised provided the source is acknowledged.Join us to work for every patient in Europe!Who we are?Serving a population of 500 million citizens, we promote and protect public 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.What do we offer?

• Meaningful work contributing to protecting the health of every individual and animal in Europe within 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)

Benefits(applicable only to Temporary and Contract vacancies)

• Initial 5 year contract with competitive monthly tax-free salary 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

Read more aboutUseful links:

Expected salary

€1942.19 per month

Location

Amsterdam, Noord-Holland

Job date

Wed, 19 Mar 2025 02:48:47 GMT

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