Assistant (multiple areas)

About this position:

The European Medicines Agency (EMA) is looking for professionals to provide administrative support across Agency various organisational entities. 

We are looking to fill multiple roles. Examples:

Scientific Support Assistant – provides administrative and regulatory support across lifecycle of human or veterinary medicines, contributing to the assessment of their safety, efficacy, and quality and helping to deliver consistent, high quality regulatory outcomes.

Access to Documents Assistant – is responsible for the process of management of access to documents (ATD) requests as per the assigned ATD portfolio, answering RFIs and interacting with stakeholders, as appropriate.

Administrative Assistant - provides administrative support to various stakeholders, including coordinating meeting logistics and planning, preparing reports, and contributing to projects across different areas of activity.

Clinical Data Publication Assistant – is responsible for the process of management of Clinical Data Publication procedures within the assigned portfolio and interacting with stakeholders, as appropriate.

Liaison Assistant - supports the coordination and strengthening of the Agency’s relationships with a wide range of stakeholders and contributes to the Agency’s operations and facilitates scientific and regulatory collaboration between EMA/EU, international networks, and relevant stakeholders.

Among other duties pertinent to the roles above, you will:

• Provide accurate and timely administrative and organisational / logistic support in the preparation and follow-up of internal and / or external scientific, regulatory and procedural meetings;
• Prepare and ensure publication of relevant documents using pre-defined templates and formats where appropriate;
• Contribute to the management of files, statistics, data, databases, tracking lists, mailing lists and correspondence relating to the specific tasks assigned;
• Develop and update SOPs (Standard Operating Procedures), WINs (Work Instructions), user manuals, guidance documents and templates;
• Use administrative and procedural knowledge to identify potential difficulties, escalating issues to scientific staff and management as necessary;
• Contribute to the development and improvement of the processes.  

Apply if you meet these eligibility criteria:

General conditions
1. Full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2. 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. Fulfilled any obligations imposed by applicable laws concerning military service.

Specific conditions
1.    A level of post-secondary education attested by a diploma, or a level of secondary education attested by a diploma giving access to post-secondary education, and appropriate professional experience of at least three years.

General Condition 1 and Specific Conditions 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 in accordance with the Assessment Criteria below.

You will also need:

Experience

• At least 3 years of relevant professional experience in working in an environment characterised by processes and procedures, SOPs, WINs or other guidance documents.
• Experience developing and updating SOPs (Standard Operating Procedures), WINs (Work Instructions), user manuals, guidance documents and/or templates
• Experience in database management and analysing i.e. data entry and basic reporting;
• Experience in stakeholder management;
• Experience in drafting various types of communication;
• Experience using IT tools, applications and systems, including MS Office (including document management, formatting and editing , virtual meeting platforms);
• Experience In tracking deadlines, deliverables, or regulatory submissions. 
  
  

Skills & Knowledge 

• Attention to details;
• Ability to handle sensitive information with discretion;
• Basic understanding of the European Union institutional and working environment.

Competencies you need to have:

Role competencies

• Continuous improvement, Intermediate
• Prioritising and organising, Basic

Sub-family competencies    

• Administrative excellence, Intermediate
• Event and meeting management, Intermediate
• Corporate communication, Intermediate
• Applied knowledge, Basic

Grade competencies    

• Adaptability and agility, Basic
• Coping with pressures and setbacks, Intermediate
• Analysing and problem solving, Intermediate

Core competencies    

• Ethics and integrity, Basic
• Team collaboration, Intermediate
• Customer centricity, Basic
• Results orientation    Basic
• 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 nice to have:

Education

• Bachelor in the field of studies specific to the role; alternatively, certificates or diplomas showing attendance of specialisation courses on matters relevant to the role; 

Experience

• In document management systems and managing complex administration; 
• As administrative/project/team/personal assistant; 
• In organising large and complex meetings/events with multiple stakeholders;
• In working in different EU regulatory bodies or multinational organizations.

Skills & Knowledge 

• Knowledge of the EU regulatory framework;
• Knowledge of (business) process management.

Certificates

• Certified administrative professional;
• Business writing and document production;
• Records management;
• Event and project management.