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SNE/Clinical Specialist in Infectious Diseases

Type of position:  Seconded National Expert
Job Type:  15 09 2022 23:59 CET

Type of position: Seconded National Expert 

Job title: SNE/Clinical Specialist in Infectious Diseases

Deadline for applications: 15 09 2022 23:59 CET 

 

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines.

 

We are looking for National experts on secondment. This means staff from other European public-sector bodies can work at the European Medicines Agency (EMA) for short periods of time through the national expert on secondment (SNE) programme. The aim of this programme is to enhance and develop the relationship between European public administrations.

 

SNEs serve a dual role: they bring their expertise to EMA and take back to their home administration the knowledge acquired during their period of secondment. SNEs remain in the service of their employer. Secondment is not equivalent to employment, nor does it lead to employment by EMA. Periods of secondment may last between six months and two years. This is renewable once or more, up to a total of four years.

 

This announcement is governed by the Rules governing the secondment of national experts. For further information please visit our Careers portal.

 

 

Role Summary

 

Provide scientific, regulatory or procedural input and oversight relating to the safety and efficacy aspects of human medicines.

In the office of Vaccines and therapies for infectious diseases (H-TA-INF), the scientific specialist will be mainly responsible for providing expertise to the office in the area of antimicrobials, with an emphasis on antimicrobial resistance. 

The role will also include contribution, management and scientific oversight over EMA clinical assessments and risk management procedures. Furthermore, the SNE, apart from acting as advisor to the H-INF team in his/her specialised field and support the office when specialist knowledge is needed, will be providing specialised trainings to the team. 

The role will comprise cross-Agency activities:
- Contribution to the Agency’s AMR-related tasks, 
- Contribution to the Antimicrobial Resistance Task Force (AMR-TAF) 
 

Standard role duties & responsibilities

 

Perform duties reserved only for the Temporary Agent contractual category. 

Provide scientific coordination and regulatory and/or procedural support in relation to the any of the following areas:

Development, evaluation and surveillance of medicinal products for human use;

Referrals and related procedures for medicinal products for human or veterinary use;

Preparing the summary report and supporting the coordination of the initial assessment for medicines;

Deliver high-quality product information through assessment of the dossiers;

Apply EU pharmaceutical legislation to the operations of the Agency as required;  

Lead to the development of regulatory and/or procedural guidance documents and provide training as required;

Coordinate and supervise the operation of Scientific Committee meetings, Working Parties, Working Groups, Advisory/Expert Groups, etc and related activities; 

Respond to requests for information received by the EMA relevant to the scientific area of competence
 

Essential requirements

 

Education
A level of education which corresponds to completed university studies of at least three years attested by a diploma;
Field of study
Life Science (e.g. biology, chemistry, biochemistry, pharmacy).

 

Experience
3 years from the time when a university degree was awarded on completion of a minimum of three years of study;
Experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting should have been obtained in: 

In the scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines with an emphasis on anti-microbials. 

 

Skills & Knowledge
Organisational skills;

Communication skills;

Critical review and drafting of scientific and regulatory documents for expert and lay audiences;

Presenting scientific, or regulatory matters at a high level (including experts);

Proficient in English language;
Proficient in MS Office suite;

Knowledge of the typical issues in clinical development in the therapeutic area of anti-infectives;

Knowledge of general methodology for clinical development;

Knowledge of at least one area relevant for clinical development of medicines.
 

Nice to have

 

Education
Masters in a relevant field of study (Medicine or Life sciences);

Master’s degree in regulatory science and/or affairs.

Field of study:

Scientific background relevant to perform the role.


Experience

Clinical experience in the therapeutic field;

Academic research in the therapeutic field;

With medicines assessment at a National Competent Authority in the area of anti-infectives;


Skills & Knowledge
Understanding of the therapeutic area.
 

______________________________________________________________________________________________________

 

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

 

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.

Join us to work for every patient in Europe!

Who we are?

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. 

What do we offer?

  • Meaningful work contributing to protecting the health of every individual and animal in Europe within 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)

Benefits

(applicable only to Temporary and Contract vacancies) 

  • Initial 5 year contract with competitive monthly tax-free salary and 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
  • Retirement Pension Plan 

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