Scientific Officer in the Referral Office

About this position:

We are looking to recruit a highly motivated and experienced individual with a solid scientific and regulatory background  and excellent communication skills to be at the forefront of managing the important regulatory procedures known as referral procedures and contribute to ensuring that recommendations are agreed at European Union (EU) level for the safe and effective use of medicines in the EU. 

Key Responsibilities:

As Scientific officer in the Referrals office, you will: 

• Coordinate EU referral procedures for medicinal products for human use, ensuring scientific robustness, and compliance with the legislation and EMA processes. 
• For allocated procedures, serve as main liaison for internal and external stakeholders, including applicants, European Commission (EC), national competent authorities (NCAs) or international partners, communicating effectively and exhibiting diplomatic and influencing capabilities when advising on sensitive matters.
• Support the Agency's scientific committees for human medicines (e.g. CHMP/PRAC) and the regulatory network by:
  • providing regulatory, procedural, and scientific support to various committees and expert groups, 
  • preparing and reviewing key documents in relation to the allocated referral procedures, integrating relevant expertise and input from healthcare professionals/patients' (e.g. through healthcare professionals/patients' meetings, Public Hearings),
  • ensuring that high quality standards are maintained through peer-review and active participation in discussions.
• Support discussions, internally and with the EC, NCAs and the Industry, about potential referral procedures, or in the context of legal proceedings following these procedures. 
• Serve as a trusted point of reference for consultation and collaborative dialogue, while presenting information with confidence and conviction.
• Contribute to regulatory science projects and initiatives, providing specialist input, in different cross-Agency or international groups and communities and in projects with the EMA scientific committees or the EC, such as on revisions of the EU pharmaceutical legislation or policies on referral procedures-related aspects and their implementation.

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More about the team:

The Referrals office sits within the Quality and Safety Department of the Human Medicines division. It is responsible for overseeing and managing scientific reviews of medicinal products for human use resulting from safety, efficacy, quality or other scientific concerns or questions, aiming at reaching a harmonised position across the EU. The team is currently composed of 12 dynamic, dedicated individuals with a strong team spirit, working as Procedure Leads or Procedure Support coordinators. 

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Why Join Us? 

• Impactful Work: Play a crucial role in safeguarding public health. 
• Collaborative Environment: Work closely with experts and stakeholders from across the EU and beyond. 
• Professional Growth: develop expertise in a key and powerful regulatory process in an environment providing opportunities for continuous learning and development in regulatory science. 
• Dynamic Challenges: Lead procedures emerging from public health issues of various nature and contribute to the implementation of new legislation. 

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If you're ready to take on this exciting challenge and make a significant impact on public health, we look forward to your application. 

Generic role description outlining standard duties and responsibility of a Scientific Officer: https://www.ema.europa.eu/en/documents/recruitment/role-description-scientific-officer-fgiv_en.pdf

Apply if you meet these eligibility criteria:

General Conditions: 
1.    Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
2.    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 university degree of a minimum of three years in Life Science (e.g. biology, chemistry, biochemistry, pharmacy, medicine) that must have been obtained by the closing date of this vacancy notice.

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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. Failing to present these documents may result in the disqualification from the selection procedure.

Only candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.

You will also need to have:

Experience 

• Experience in the scientific, regulatory, or procedural aspects of the development, authorisation, or supervision of human medicines, obtained in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting. 

In particular: 

at least 2 years of experience coordinating projects or regulatory procedures involving multiple stakeholders, and engaging effectively across different organizational level in English language. 

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• Experience in working for a multinational organisation and/or managing multiple international stakeholders. 

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Skills & Knowledge 

• Ability to serve as trusted point of reference for consultation and collaborative dialogue. 
• Solid scientific writing skills; 
• Organisational skills;  
• Analytical skills with strong attention to details;  
• Knowledge and understanding of the EU pharmaceutical legislation. 

Competencies you will need to have:

Role competencies

• Influencing and persuading, Intermediate 
• Scientific evidence management, Basic 
• Scientific product lifecycle and procedure management, Basic 
• Prioritising and organising, Intermediate 

Sub-family competencies 

• Regulatory frameworks & strategy, Basic 
• Applied knowledge, 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 

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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

 Masters in a relevant field of study (Life sciences).