About this role
For the European Medicines Agency (EMA) we are looking for a Scientific Support Assistant to support regulatory and scientific activities within the Agency!
What are you going to do?
- Role summary: Provide administrative, regulatory and scientific support to the safety, efficacy and quality assessment of human and veterinary medicines throughout their lifecycle.
- The successful candidate will ensure accurate and timely support of scientific committees, working parties and regulatory procedures while maintaining high-quality standards.
- Standard role duties & responsibilities:- Contribute to the management and coordination of pre- and post-authorisation activities.- Provide administrative, organisational and logistical support for scientific and regulatory meetings.- Prepare and publish relevant documents using EMA templates and standards.- Maintain files, databases, tracking systems, mailing lists and correspondence.- Contribute to the development and maintenance of SOPs, WINs, user manuals and guidance documents.- Identify potential process issues and escalate risks where necessary.- Support continuous improvement and optimisation of business processes.
- Role specific duties & responsibilities: - Manage dossier data within IRIS, Microsoft Teams and SharePoint.- Coordinate and organise meetings for the Quality Working Party (QWP) and other expert groups.- Draft agendas, minutes and supporting meeting documentation.- Manage memberships of working parties and expert groups.- Support management of Declarations of Interest (DoI) and conflict of interest assessments.- Provide administrative support to medical device expert panels when required.- Support regulatory procedures and procedural meeting activities.- Act as a first point of contact for internal and external stakeholders.
- The specific tasks of an individual job holder are further detailed through the activities of the organisational entity, annual objectives and compliance with applicable