About this job:

The Human Medicines Division oversees and manages human medicines throughout their lifecycle, from evidence generation planning, through evaluation and monitoring of medicines to interfacing with stakeholders to facilitate access and optimal use. The division also supports the European regulatory network to produce patient-centred high-quality scientific opinions. 

In this role, you will provide administrative, regulatory and scientific support to the safety, efficacy or quality aspects of human medicines throughout their lifecycle, ensuring consistent outputs of high quality in the context of pre and post authorisation activities. 

This selection procedure aims to create a reserve list for a variety of different positions across the Agency, from product coordinator, to committee support assistant, to procedure manager for minor procedures or validation officer, generally involving the management and preparation of documentation related to the evaluation of medicines. 

On a daily basis, you will be cooperating with highly qualified professionals from from 30 EU and EEA countries. 

Apply if you meet 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 conditions:

1. Possess 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 3 years, completed before closing date of this vacancy notice;

2. Have at least 6 years of professional experience after obtaining the relevant diploma and before the closing date of this vacancy notice. 

You will also need to have:

Experience 

Out of at least 6 years of professional experience required above, at least 3 years of experience in working in a highly-regulated environment characterised by processes and procedures, Standard Operating Procedures (SOPs), Working Instructions (WINs) or other guidance documents;  

Experience in: 

• Database management and analysis and reporting;  
• Management of administrative procedures;
• Document management, formatting and editing;
• Stakeholder management;  
• Reviewing and drafting SOPs/WINs and updating regulatory documents and guidance.

Skills & knowledge  

Knowledge and understanding of commonly used IT tools, applications and systems, including MS Office, Adobe Acrobat, teleworking tools and meeting platforms.  

Competencies you will need to have:

Role competencies:

Analysing and problem solving - Intermediate
Continuous improvement - Intermediate

Sub-family competencies:
Administrative excellence - Intermediate
Event and meeting management - Intermediate
Corporate communication - Intermediate
Applied knowledge management - Intermediate

Grade competencies:

Adaptability and agility - Intermediate
Coping with pressures and setbacks - Intermediate
Prioritising and organising - 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- Intermediate

For more information about definitions of competencies and associated proficiency levels, please refer to the EMA Competency Framework which you can find here: EMA Competency Framework (europa.eu)

These are considered to be 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 

• Managing complex administration;  
• As administrative/project/team/personal assistant;  
• In organising large and complex meetings/events with multiple stakeholders;  
• In process improvement;  
• In project management.  

Skills & knowledge  

• Knowledge of the EU regulatory processes and procedures of the life cycle of medicinal products with high level knowledge in guidelines, policies and procedures.  
• Advance knowledge of MS Office suite 

Certificates 

• (Business) Process management

Selection procedure timelines