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SNE (Clinical Specialist for Immune and Inflammatory diseases)

Type of position:  Seconded National Expert
Job Type:  05 September 2022 23:59 CET

Type of position: Seconded National Expert 

Job title: SNE (Clinical Specialist for Immune and Inflammatory diseases)

Deadline for applications: 05 September 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 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.

 

 

About this position

In the office of therapies for immune and inflammatory diseases a need has been identified for a clinical specialist with subject matter expertise. The incumbent will be providing expertise to the office in one or more of the following therapeutic areas: Rheumatology and Immunology. This may include contribution, management and scientific oversight over EMA clinical assessments and risk management procedures. Furthermore the SNE, apart from providing specialised trainings to the H-TA-IMM team will act as an advisor in his/her specialised field and support the office when specialist knowledge is needed. 

 

In this post you will

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 or veterinary use and of Maximum Residue Limits for substances for veterinary use;
  • Referrals and related procedures for medicinal products for human or veterinary use;
  • Management of requests for scientific advice, protocol assistance, parallel scientific advice with other decision makers (e.g. FDA or HTA bodies), as well as qualifications;
  • Preparing the summary report and supporting the coordination of the initial assessment for orphan medicine designation, paediatric investigation plans or limited markets classifications;
  • The delivery of high-quality product information through assessment of invented names, product information and its translations, mock-ups and specimens, and provision of advice and training on product information guideline principles;
  • 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 the requests for information received by the EMA in the scientific field.
     

Apply if you have these eligibility criteria

  • Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway; 
  • 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); 
  • Be currently employed in the public sector (such as a university, research institute, public hospital or regulatory body) in a European Union (EU) Member State and for the foreseeable time of the tenure as SNE remain in such employment.

 

Nice to have

Experience 

  • In information analysis and reporting on scientific/regulatory matters;
  • Clinical experience in a therapeutic field;
  • Pharmaceutical development experience;
  • With medicines assessment at a National Competent Authority;
  • Regulatory scientists/product manager experience;
  • Experience in the preparation and/or review of any part of an application dossier;
  • Experience in working with stakeholders (industry and national/international authorities).

Skills & Knowledge

  • Understanding of medicines regulation.

 

______________________________________________________________________________________________________

 

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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