Scientific Support Assistant

To provide administrative and secretarial support to the Labeling (LAB) Office, ensuring efficient and consistent completion of work to optimise the performance of the business processes. In addition the role has specific responsibility for managing the post-opinion linguistic review process and the coordination of translation activities via the Translation Centre (CdT) in Luxembourg., The duties of the role are performed under the supervision, including guidance and support, of temporary staff.

• Contribute to the management and coordination of overall activities relating to pre- and post-authorisation activities;
• Provide accurate and timely administrative and organisational / logistic support in the preparation and follow-up of internal and / or external scientific, regulatory and procedural meetings;
• Prepare and ensure publication of relevant documents using pre-defined templates and formats where appropriate;
• Contribute to the management of files, statistics, data, databases, tracking lists, mailing lists and correspondence relating to the specific tasks assigned;
• Develop and update SOPs (Standard Operating Procedures), WINs (Work Instructions), user manuals, guidance documents and templates;
• Use administrative and procedural knowledge to identify potential difficulties, escalating issues to scientific staff and management as necessary;
• Contribute to the development and improvement of the processes.

Role specific duties & responsibilities:

• Handling and monitoring of all procedures requiring linguistic review, including all aspects related to translations performed by the CdT;
• Management of the operational part of the financial compensation scheme for linguistic review performed by Member States; this includes the operational tasks necessary for the completion of financial transactions related to the work performed by CdT;
• Responsibility for document management of all papers, correspondence concerning assigned projects to support development, implementation and adherence to (Integrated Quality Management (IQM) systems;
• Handle internal and external daily communication in a pro-active manner, via phone, e-mail, mail personally and ensure follow-up as required. Act as a contact point for internal and external queries in relation to LAB activities;
• Assist Office staff with drafting, editing, formatting, tabling, distribution, filing and publication of documents (e.g. QRD reference documents etc.), including maintenance of QRD/NRG internal webpages; preparation of presentations and other documents for internal and/or external use;
• Record and compile statistical data on the performance of the LAB Office to be used for annual reports, work programs and other Agency reporting requirements;
• Organise meetings, teleconferences and other meetings as required, with internal and external participants, including editing of documents during meetings and arranging logistics (e.g. booking meeting rooms, distribution of documents, etc.); these tasks include in particular the organisation of QRD Plenary, QRD Sub-group meetings, as well as the NRG related meetings;
• Support the Head of Office in the management of day-to-day operations;
• Escalate matters requiring manager's input to Head of Office or Labelling Specialist.

Do you have experience in Microsoft Word?, Do you have a Pre-vocational secondary education?, * Post-secondary education attested by a diploma, or secondary education giving access to post-secondary education with at least three years of relevant professional experience.

Experience:

• Up to 6 years of full time relevant professional experience;
• In working in a regulatory environment characterised by processes and procedures, SOPs, WINs or other guidance documents;
• In database management and analysis and reporting;
• In stakeholder management;
• In working in public or regulatory sector.

Skills & Knowledge:

• Sound knowledge of core administrative activities (e.g. records management, meeting management);
• Strong organisational skills with proven ability to juggle competing priorities effectively;
• Self-starter with the ability to plan and manage own workload effectively;
• Effective communication skills with the ability to co-ordinate meetings/teleconferences with partners and stakeholders;
• Team-player, willing to support colleagues across the whole team and across Divisional boundaries;
• Able to deliver accurate work under pressure;
• Excellent document management knowledge;
• Proficient in Microsoft Outlook, Word and Excel with basic skills in PowerPoint and Access;
• Customer orientated mind-set;Administrative skills;
• Knowledge and understating of commonly used IT tools, applications and systems, including MS Office, teleworking tools and meeting platforms.

The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. The agency is located in Amsterdam, Netherlands and employs over 900 people from across the EU. EMA's mission is to protect public health by ensuring that all medicines available in the EU are safe, effective, and of high quality.