SENIOR SPECIALIST TRANSLATIONAL SCIENCE
|Bedrijf||European Medicines Agency|
|Aantal uren per week||40 uur|
About this position:
We are seeking talented individuals to provide scientific support to the Translational Sciences Office of the European Medicines Agency. As Senior Scientific Specialist in Translational Sciences, you will contribute to the successful design and implementation of the EMA initiatives our office leads on or contributes to. These include non-clinical & clinical pharmacology, 3Rs (refinement, replacement, reduction of animal studies), environmental risk assessment, as well as medicines in pregnancy & breastfeeding.
As a Senior Scientific Specialist in Translational Sciences at EMA, in close collaboration with other functions, you will:
- provide expert scientific coordination and regulatory and/or procedural support to the work of Committees, the Non-Clinical Working Party, the 3Rs Working Party, the European Commission, and other relevant stakeholders and be expected to engage in related regulatory science initiatives ;
- manage and maintain oversight of the deliverables of the working parties and operational expert groups and provide support to the groups’ Chair in preparation and during the meetings;
- help the Agency prepare for and implement the new pharmaceutical legislation in the areas of 3Rs, ERA, and ‘one substance one assessment’;
- lead the development and updating of regulatory and/or procedural guidance documents (guidance documents, methodologies, question & answer and other relevant documents) and provide training as required;
- respond to the requests for information received by EMA in the scientific field; and
- foster collaboration with the European Commission and the EU National Competent Authorities.
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:
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.
1. possess a university degree (minimum of four years) in Medicine or related subject, biomedical sciences and / or translational sciences that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ professional experience after obtaining the relevant degree, that must have been obtained by the closing date.
2. possess a university degree of three years in Medicine or related subject, biomedical sciences and or translational sciences that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ professional experience after obtaining the relevant degree, that must have been obtained by the closing date.
For general condition 1 and for specific conditions 1 and 2 you will be required to provide proof in the application form and 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:
Out of the years of professional experience required above (eligibility - specific conditions), at least 5 years' experience with aspects of environmental risk assessment (ERA) or translational sciences as applied in pharmaceutical industry, the regulatory network, or academia.
Skills & Knowledge
- Thorough knowledge and understanding of translational sciences;
- Able to critically assess studies and their implications for public health;
- Leadership skills to implement relevant translational sciences considerations into support for, and assessment of, medicinal products coming for scientific advice or marketing authorisation.
More details about the job at: Senior Translational Sciences Specialist (europa.eu)
Closing date for applications: 22 September 2023 23:59 CET