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SNE/Quality Specialist

Type of position:  Seconded National Expert
Job Type:  30 May 2022 23:59 CET

Type of position: Seconded National Expert 

Job title: SNE/Quality Specialist

Deadline for applications: 30 May 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.

 

 

About this position

 

A national expert position is now available in the Pharmaceutical Quality Office, within the Quality and Safety of Medicines Department, for a duration of up to 2 years.

 

You will join a close-knit and supportive team of quality specialists providing scientific input on quality aspects of medicines for human use.  The role includes the provision of scientific specialist input on pharmaceutical quality matters to applications for marketing authorisation, scientific advice and post-authorisation procedures for human medicinal products containing primarily biological and biotechnologically derived substances (including vaccines and ATMPs). The position is within the pharmaceutical quality office but the role also involves working closely with the EMA product team and experts from the EU regulatory network of its scientific committees and working parties.  

 

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 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.

 

 

You will also need:

 

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. pharmacy, biology, chemistry, biochemistry).

 

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 and/or manufacture of medicines with a focus on pharmaceutical quality matters of human medicines

              - In working with medicinal products containing medical devices and associated regulatory framework

 

Skills & Knowledge

  • Knowledge of the typical issues in quality, non-clinical, or clinical development of a medicinal product with a focus on pharmaceutical quality;
  • Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU;
  • Critical review and drafting of scientific and regulatory documents for expert and lay audiences;
  • Organisational skills;
  • Communication skills;
  • Presenting scientific, or regulatory matters at a high level (including experts);
  • Proficient in English language;
  • Proficient in MS Office suite;
  • Knowledge of general methodology for quality, non-clinical, or clinical development;

 

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

  • Expertise in assessing medicinal products for clinical trials or marketing authorisation at an EU regulatory authority;
  • Pharmaceutical development experience, ideally in the area of biological and biotechnologically derived medicines including vaccines and/or ATMPs;
  • 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    

  • Knowledge of the development of a medicinal product and associated sciences including pharmacy, biology, biotechnology and pharmaceutical formulation;
  • Understanding of medicines regulation in the EU;

 

______________________________________________________________________________________________________

 

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

  • 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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