Scientific Officer Endocrine&Cardiovascular diseases

Found in: Lensa US P 2 C2 - 2 weeks ago


Amsterdam, United States AKKA Technologies Full time

Full time - Scientific Officer Endocrine&Cardiovascular diseases | H-464Client: European Medicines AgencyPlanned start date: 13-05-2024End date: 31-12-2024Deadline to apply: 03-04-2024Have you completed a Master's degree in Life Sciences or related? Do you have experience in Regulatory Affairs, centralised procedure, and experience in liaising with regulatory authorities and public health authorities? Do you speak 2 European languages fluently? Then this position could be an interesting position for youWe, Akkodis Life Sciences, are looking for a Scientific Officer (Endocrine&Cardiovascular diseases) who can strengthen the team at our customer, European Medicines Agency, in Amsterdam.Role summaryProduct lead in the Office for Therapies for endocrine and cardiovascular diseases, ensuring that high quality, consistent scientific, regulatory and procedural input is provided, throughout the product lifecycle.Your roleThe specific tasks of an individual job holder, linked to this role description, are further detailed and referenced in:* activities of the organisational entity within which the job holder carries out those tasks;* the set of annual performance and development objectives, which are established together with the reporting officer;* the requirement to comply with SOPs, WINs, confidentiality undertaking and other documentation relevant to the role and its scope. These will be agreed upon with the reporting officer upon assuming duties.Communication and professional contactsRequired to receive and convey information, orally and/or in writing, of a non-routine nature which needs careful explanation and interpretation e.g. explaining or interpreting policies, systems, processes; dealing with matters of a sensitive nature; formulating responses to more complex enquiries; drafting news items, letters, minutes, reports or presentations.Regular professional contacts with others inside and/or outside the Agency on functional matters. Solicits/gives information, provides advice/guidance and should use initiative. A likely requirement is to influence others' thinking and negotiate with various parties within own job responsibilities. Normally connected to the Agency's core business or a project.In particular, a Scientific Officer will:* Liaise with internal and external stakeholders and interested parties, internal and external subject experts;* Coordinate, support, lead effective communication and relations;* Daily internal communication and interaction related to the management of the procedures with other colleagues across the Agency and the extended product team members;* Prepare and contribute to the preparation of communication documents for allocated procedures;* Contribute to the preparation of Scientific Committee meetings, Working Parties, Working Groups, Advisory/Expert Groups, including providing scientific support as applicable.What do we offer?Employment for 40 hours per week and the opportunity to work at innovative and progressing companies. You will be part of a fast growing Life Sciences team that is represented in different industries (biotech, pharma, food) and present in Life Sciences clusters in The Netherlands.* Attractive salary of 4.564,31, depending on experience and education, more than 5 years of paid fulltime working experience your salary would be 5.164,29 gross per month;* The opportunity to work at the European Medicines Agency;* Work-life balance with 24 to 36 holidays;* Company fitness, health insurance and good pension scheme;* Annual team events;* Options to attend training, coaching and a personal development scheme;* Career opportunities matching your aspirations and development.Your profileWe are looking for candidates with the following certification and skill set:Education:* Master's degree in Life Sciences (Biology, Chemistry, Biochemistry, Pharmacy, Medicine), which corresponds to completed university studies of at least three years attested by a diploma;Experience and knowledge:* Experience in the centralized procedure;* Experience in liaising with regulatory authorities and public health authorities;* Initiative, diplomacy and good judgement;* Knowledge of the EU pharmaceutical legislation and (European Medicines Agency) regulatory framework;* 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;* In information analysis and reporting on scientific/regulatory matters;* Clinical experience in a therapeutic field;* In working for a multinational organisation and managing multiple international stakeholders.Besides that:* You are a team player, have a strong ability to follow detailed processes and procedures and tact and discretion in the handling of confidential files and information.* Candidates must have level C1 in spoken and written English and level B2 in another official EU language (Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish).About AkkodisWe are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related.We have > 60 Consultants working at the EMA, Astellas, GSK, Unilever, Corbion, MSD, Organon, Aspen and many moreAre you interested in this challenge, or do you want to come in touch?Please contact the Akkodis Life Science Team via lifesciences@akkodisgroup.com and/or send your CV and motivation letter and one of the Talent Acquisition Specialists will contact you.Please apply via the button on this page and please include in your CV the following details:* The period of the education(s), jobs and internships: dd-mm-yy till dd-mm-yy* Were the jobs, internships and trainee ships: paid or unpaid* Were the jobs, internships and trainee ships: full time or part time (%)

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