Scientific Officer (Oncology and Radiopharmaceuticals)

SCIENTIFIC OFFICER (ONCOLOGY AND RADIOPHARMACEUTICALS) | EUROPEAN MEDICINES AGENCY | AMSTERDAM

Start: ASAP / 01-09-2025

End: 31-12-2025

Deadline to apply: 11/08/2025 

Your role

Provide scientific, regulatory or procedural input and oversight relating to the safety, efficacy and quality aspects of human or veterinary medicines.

Your responsibilities are:

The duties of the role are performed under the supervision, including guidance and support, of temporary staff.

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.
• The 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 contacts

• Required 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.

Welkom bij Akkodis

We 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, Unilever, Corbion, MSD, Organon, Aspen and many more! 

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.

• Temporary contract, depending on the budget the possibility to extend;
• Attractive salary;
• Work-life balance with 24 to 36 holidays;
• Company fitness, health insurance and good pension scheme;
• Options to attend training and coaching.

Kandidaat Profiel

Your profile

• A level of education which corresponds to completed university studies (Biology, Chemistry, Biochemistry, Pharmacy or related) of at least three years attested by a diploma;
• Experience in pharmaceutical legislation dealing with marketing authorisation applications;
• 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 OR In working with medicinal products containing medical devices and associated regulatory framework;
• In regulatory affairs on EU-wide or national procedures or other work on the regulation of medicines;
• In information analysis and reporting on scientific/regulatory matters;
• Clinical experience in a therapeutic field;
• Strong preference: candidates have level C1 in spoken and written English and level B2 in another official EU language.

Interested?

Please contact your Talent Acquisition Specialist of Akkodis Life Science by sending your CV and motivation letter.