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Non-Clinical Science Officer

1 maand geleden

Amsterdam, Nederland The European Medicines Agency (EMA) Voltijd

Non-Clinical Science Officer

Type of position: Contract agent Job Type: 20 June 2024 23:59 CET

Job grade : FGIV 

Internal job grade and Interagency: FGIV

Type of position : Contract agent 

Selection procedure reference : EMA/CA/10373 

Job title : Non-Clinical Science Officer 

Talent Pool: FGIV Science & Regulation

Deadline for applications : 20 June 2024 23:59 CET 

Salary: 3982.82 Euro  (including local weighting) plus benefits (see calculators on the right)

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About this position:

We are seeking talented individuals to provide scientific, regulatory and procedural know-how to support the work of the Human Medicines Division of the European Medicines Agency.
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.
As Non-Clinical Science Officer in the Human Medicines Division, you will contribute to the promotion and protection of public health in the European Union and the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. You will also support the development of innovative medicines that make a difference for patients. In this role you will be supporting EMA’s scientific committees and expert groups and cooperate with highly qualified professionals from 30 EU and EEA countries.
As Non-Clinical Science Officer in the Human Medicines Division, in close collaboration with the various functions of the division and across the EMA, you will:

Provide expert scientific support in translational sciences, covering one or more specific areas (e.g. non-clinical, clinical pharmacology, environmental risk assessment) across Agency activities; Actively contribute to scientific advice and protocol assistance in pre-submission processes, including pre-submission meetings and SAWP discussions; Provide advice and input into the finalisation of documents/letters/guidance in all aspects of translational sciences matters to the EMA and the EU network as requested; Identify new and re-occurring topics/issues requiring further guidance or official position of committees/WPs; Act as EMA topic leader as required; Peer-review rapporteurs’ assessment reports for initial Marketing authorisation applications (MAA) and selected post-authorisation procedures (such as extension of indication and referrals) in relation to translational sciences aspects; Provide scientific secretariat to relevant WPs/DGs and committees, if appointed, in liaisons with other WPs/DGs and committees, with main input into the scientific secretariat to the relevant working parties; Provide input into emerging safety issues, responses to requests from the European Commission and other EU bodies, as required in the area of translational sciences; Identify new and re-occurring topics/issues requiring further guidance or official position of committees/WPs; Engage in related translational science initiatives, as requested.

Here is the link to the Role Description of Translational Sciences Officer outlining generic duties and responsibilities:

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 minimum of three years in either  Pharmacy, Medicine, Biomedical Sciences, Biochemistry or (eco)Toxicology that must have been obtained by the closing date of this vacancy notice;

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

Work experience with aspects of translational sciences as applied in pharmaceutical industry, the regulatory network, or academia.
In particular:

At least 2-years professional experience as non-clinical specialist and/or in the evaluation of risks to the environment posed by medicines or other chemicals, gained in a regulatory authority or the pharmaceutical industry or in a post-doctoral position in a university department.

Skills & Knowledge

Thorough knowledge and understanding of translational sciences; Good knowledge of the EU pharmaceutical legislation and procedures underpinning the development, evaluation, and surveillance of medicinal products for human use. 

Competencies you will need to have:


Role competencies 

Scientific evidence management - Basic Scientific product lifecycle and procedure management - Basic

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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The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its for more information on the definitions of these competencies and their associated levels.

These are considered nice to have:

Education

Master in the field of pharmacy, medicine, biology, biochemistry, biomedical sciences, (eco)toxicology.

Selection procedure timelines

X

Deadline for applications

20 June 2024 23:59 CET 

Preliminary Assessments

Foreseen: 19 July 2024 

Final assessments

Foreseen: between 23 August and 30 August 2024

Decision expected

Mid September 2024

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 competences in different steps of the selection procedure.

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

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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 and Sub-family 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.

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Assessments

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.

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Reserve list and/or job offers

When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.

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

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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.

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