Job information

  • The Netherlands - Amsterdam
  • Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Italian, Latvian, Lithuanian, Maltese, Norwegian, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish
  • €4500 - €5100 per month
  • Temporary
  • Pharmaceutical, Medical and Scientific
  • MD 24526
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We have a unique opportunity for you to demonstrate your scientific administration expertise within the leading EU institution of medicines and pharmacology based in Amsterdam!

We are the long-standing agency, trusted for over 20 years to recruit for interim positions at the European Medicines Agency (EMA). The EMA are the medicines regulatory organisation responsible for public human and animal health throughout the European Union. They are now looking for a Scientific officer (Referrals) to join them on an initial 6-month temporary (Interim) contract. Deadline to apply is Tuesday 09/04/2024.

This is a full-time position, 40 hours per week, and candidates are required to be based in the Netherlands Monday-Friday and to work 2 days per week in the office in Amsterdam.

You would contribute to leading referral procedures in line with the agreed processes with focus on timely and high-quality delivery of scientific opinions, including liaison with internal and external stakeholders; and preparing and ensuring the timely publication of relevant documents. This is an exciting opportunity to join an institution that provides a truly international working environment where everyone is passionate about public health.

Your responsibilities will include:

  • 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;

Profile:

  • University studies of at least 3 years in Life Science (biology, chemistry, biochemistry, pharmacy).
  • Excellent organisational, communication and time management skills;
  • Fluency in English and at least one other EU language -Spanish, Czech, Danish, German, Estonian, English, French, Italian, Latvian, Lithuanian, Hungarian, Maltese, Dutch, Polish, Portuguese, Slovenian, Slovakian, Finnish, Swedish, Greek, Romanian, Bulgarian, Croatian, Norwegian, Icelandic

Essential requirements:

Up to 3 years of full time professional relevant experience;

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

A minimum of 3 years of professional experience in at least one of the following:

  • Coordinating and/or assessing EU referral procedures in a pharmaceutical company, regulatory authority or other relevant organisation

or

  • Working in an international regulatory environment related to the evaluation of medicines, either within EU regulatory medicines agencies or interacting with regulatory agencies, in a role that involves coordinating scientific reviews involving multiple and international stakeholders.

To apply, please send your CV in English and in Word format to Marie-Anne.
languagematters is acting as an employment agency in relation to this vacancy.

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