Scientific officer in referral office

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Job grade: FGIV

Internal job grade and Interagency: FGIV

Type of position: Contract agent

Selection procedure reference: EMA/CA/10868

Job title: Scientific Officer in the Referral Office

Talent Pool: N/A

Salary: 4,270.49 Euro (including local weighting)[1] plus benefits (see calculators on the right) (based on a fulltime contract (40hrs/week))

Location:[[Amsterdam]];[[The Netherlands]](relocation to take up duties is mandatory)

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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.

General Conditions:

Maximaliseer uw kans op een succesvolle sollicitatie door ervoor te zorgen dat uw cv en vaardigheden goed aansluiten.
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.

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.

• 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
• 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
• 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 .

Education

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

Selection procedure timelines

Selection procedure timelines are subject to changes

Deadline for applications

05/05/2025 23:59 CET

Preliminary Assessments

Foreseen: 23/06/2025

Final assessments

Foreseen: 16-17 July 2025

End of July/ Beg. of August 20 25

Selection process

Only eligible candidates (see eligibility criteria) will be assessed by the selection committee.

Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competencesin different steps of the selection procedure.

Note: Candidates who fail any assessment linked to any Need to Have requirement, Sub-family , Grade specific competencies, R ole competencies and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria.

Before the start of the selection procedure, it is decided which criteria and competences will be assessed at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3. selection procedure) for an overview of the criteria and competences assessed at each stage of the process.

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Shortlisting

In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria, Sub-family competencies and Role Competencies.

The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form.

To carry out this assessment, each of your responses will be awarded points (0 to 10). The points are added up to identify those candidates whose profiles best match the duties to be performed as advertised in the vacancy notice.

Next steps of selection may include a preliminary assessment. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice.

Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above).

Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed.

This selection procedure is run to cover a specific vacancy(ies), therefore, as a result of the assessments, the selection committee will recommend the best candidate(s) for the specific vacancy in question plus 2-3 alternate candidates among those qualified and suitable to the Executive Director of the Agency. An additional interview may be arranged before the final decision to recruit the candidate. Those alternate candidates may be offered the position in case the initially selected candidate rejects or is unable to accept the offer or their employment is not confirmed after the probation period, but they are not placed in any reserve list/Talent Pool.

The selected candidate, as well as the alternates, will be informed accordingly of the result of the selection procedure.

More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our careers website.

Contract Agent posts differ from Temporary Agent posts in terms of categories, function groups, grades and remuneration and career progression.

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Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates.

The successful candidate will be required to relocate to the Netherlands to pick up duties.

[1] The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location inAmsterdam, the Netherlands , is 111.4. Please consult the Eurostat and Commission websites for more information on weightings.

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Domenico Scarlattilaan 6 - 1083HS Amsterdam - The Netherlands

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.

• Meaningful work contributing toprotecting the health of every individual and animal in Europewithin 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)

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

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