Scientific officer Referrals on the EMA EU Langs

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We’ve got a singular alternative so that you can display your scientific administration experience inside the main EU establishment of medicines and pharmacology primarily based in Amsterdam! We’re the long-standing company, trusted for over 20 years to recruit for interim positions on the European Medicines Company (EMA). The EMA are the medicines regulatory organisation accountable for public human and animal health all through the European Union. They’re now in search of a Scientific officer (Referrals) to hitch them on an preliminary 6-month momentary (Interim) contract. Deadline to use is Tuesday 09/04/2024. This can be a full-time place, 40 hours per week, and candidates are required to be primarily based within the Netherlands Monday-Friday and to work 2 days per week within the workplace in Amsterdam. You’d contribute to main referral procedures according to the agreed processes with concentrate on well timed and high-quality supply of scientific opinions, together with liaison with inside and exterior stakeholders; and making ready and guaranteeing the well timed publication of related paperwork. That is an thrilling alternative to hitch an establishment that gives a very worldwide working surroundings the place everyone seems to be obsessed with public health. Your duties will embrace: Improvement, analysis and surveillance of medicinal merchandise for human or veterinary use and of Most Residue Limits for substances for veterinary use; Referrals and associated procedures for medicinal merchandise for human or veterinary use; Administration of requests for scientific recommendation, protocol help, parallel scientific recommendation with different determination makers (e.g. FDA or HTA our bodies), in addition to {qualifications}; Getting ready the abstract report and supporting the coordination of the preliminary evaluation for orphan medicine designation, paediatric investigation plans or restricted markets classifications; The supply of high-quality product info by way of evaluation of invented names, product info and its translations, mock-ups and specimens, and provision of recommendation and coaching on product info guideline rules; Profile: College research of a minimum of 3 years in Life Science (biology, chemistry, biochemistry, pharmacy). Wonderful organisational, communication and time management expertise; Fluency in English and a minimum of one different 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 Important necessities: As much as 3 years of full time skilled related expertise; Expertise in both a reliable authority within the area of medicines regulation, the pharmaceutical business or in a healthcare / educational setting ought to have been obtained in: Within the scientific, regulatory, or procedural points of the research, improvement, authorisation, productions or supervision of human or veterinary medicines; In working with medicinal merchandise containing medical gadgets and related regulatory framework; A minimal of three years {of professional} expertise in a minimum of one of many following: Coordinating and/or assessing EU referral procedures in a pharmaceutical firm, regulatory authority or different related organisation or Working in a global regulatory surroundings associated to the analysis of medicines, both inside EU regulatory medicines businesses or interacting with regulatory businesses, in a task that entails coordinating scientific critiques involving a number of and worldwide stakeholders. To use, please ship your CV in English and in Phrase format to Marie-Anne. languagematters is appearing as an employment company in relation to this emptiness.
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