Change Management Officer

The Agency is looking for a programme/project and change management role profile to support a transformation initiative related to the use of clinical study data in regulatory decision-making. More specifically, the successful candidate will contribute to the development and implementation of change management activities (e.g. trainings, communication, stakeholder engagement, development and update of processes and guidance, etc) related to the use of individual patient data in electronic structured format to support the assessment of new marketing authorisation applications.

This will include preparing for the implementation of the new pharmaceutical legislation (NPL) which will require systematic submission of clinical study data with most marketing authorisation applications in the centralised procedure as of 2028, strengthening the support to EMRN and applicants for voluntary data submissions in the meantime, 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, but also international regulatory agencies.

Standard role duties & responsibilities:

• The duties of the role are performed under the supervision, including guidance and support, of temporary staff:
• Support the creation and effective operation of a change enabler network for a pending change;
• Support the preparation for change by assessing the magnitude of change (as is versus to be) and the organisation’s change readiness and capacity to absorb change;
• Support and contribute to the co-creation of the Change Management Strategy and plan with the project manager, business sponsor and the project team. Drive the implementation of the Change Management Strategy and Plan;
• Support identification and analysis of change adoption risks and support implementation of countermeasures;
• Support and contribute to the identification and mitigation of resistance. Support stakeholder analysis and the design and implementation of stakeholder management activities;
• Support and contribute to a detailed change impact analysis;
• Propose metrics to measure change adoption and support tracking, reporting and analysis of metrics as well as follow up actions;
• Support the creation and implementation of a communications strategy and plan to ensure meaningful communication with stakeholders, in coordination with the project manager, sponsor and change team;
• Support learning needs analyses as well as design and implementation of training plans to build capability for change, in close collaboration with the project manager, trainers and subject matter experts;
• Pro-actively exchanges change management knowledge and experience with stakeholders and peers.

Role specific duties & responsibilities:

The specific tasks of an individual job holder, linked to this role description, are further detailed and referenced in:

• activities of the organisational entity within which the job holder carries out those tasks;
• the set of annual performance and development objectives, which are established together with the reporting officer;
• the requirement to comply with SOPs, WINs, confidentiality undertaking and other documentation relevant to the role and its scope. These will be agreed upon with the reporting officer upon assuming duties.

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

Experience:

• Up to 3 years of full-time relevant professional experience;
• Experience with and good understanding of the EU medicines regulatory system

Skills & knowledge:

• Power Point, Word and Excel;
• Communications techniques and étiquette;
• Logic and argumentation.
• Programme/project management and coordination
• Change management
• Communication
• Collaboration and team work

A fulltime, temporary job from 3-08-2026 until 31-12-2026 (assignment extention is possible)

Salary range:

• 5,036.62 gross per month (5 years of experience)
• 5,698.69 gross per month (5 - 17 years of experience)
• 7,295.27 gross per month (17 years of experience or more)

Interesting and challenging work that brings value to European citizens;

A diverse and stimulating working environment Where will you work?

The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. The agency is located in Amsterdam, Netherlands and employs over 900 people from across the EU. EMA’s mission is to protect public health by ensuring that all medicines available in the EU are safe, effective, and of high quality.