SNE/Scientific Specialist (Innovation and Development Accelerator)

About this position

The Innovation and Development Accelerator (INO) Workstream is looking for a seconded national expert for 2 to 4 years to work full time at the EMA headquarters in Amsterdam.
The INO goal is to identify, support and accelerate the development of innovative health care solutions that lead to better patient treatments.
Main activities and tasks:
•    Enabling and leveraging research and innovation in regulatory science through analysing and discussing development forecasts and scientific trends across EMA and its committees, and engaging action.
•    Supporting innovation through the development of first-contact functionalities embodied within the ITF/EU-IN/SME Office and academic liaison framework.
•    Systematically reviewing future innovations and trends, to enable the Agency and its partners to adapt and encourage innovations to reach the market with minimal developmental, legal, regulatory, process or procurement bottlenecks.
 

In this role you will

Some of the tasks you will be working on:

•    Supporting a platform for stakeholder interactions on early-stage innovative developments in medicines and related technologies and methods (first-contact functionalities)
•    Support a regulatory intelligence function to capture/identify emerging science and technology trends by monitoring and systematically reviewing innovations and scientific and technological trends (Horizon Scanning) and their translation into regulatory-science strategies and governance
•    Support building of capability and capacity of expertise within the network by forecasting activities fostering collaboration within the network
•    Contribute to the competitiveness of the European Innovation ecosystem by promoting mutual exchange and interactions between medicine regulators and stakeholders.
•    Facilitate the delivery of strategic priorities for the European Medicines Regulatory Network (EMRN) as outlined in the European Medicines Agencies Network Strategy (EMANS) 2028 and associated workplans
•    Contribute to preparations and the implementation of changes to other legislative frameworks including implementation of the new pharmaceutical legislation
•    Support the EMA Artificial Intelligence Coordination Group
•    Support the ICMRA AI Steering Group
•    Support the EMA Pharmacogenomics Community

Apply if you meet these eligibility criteria

• Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway; 
• Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union;
• Are currently employed in the public sector (such as a public intergovernmental organisation (IGO) national / regional / local public administration) in a European Union (EU) Member State and are due to remain in such employment for the foreseen duration of the SNE position.

You will need

Education

• A level of education which corresponds to completed university studies of at least three years attested by a diploma.

Field of study
Life Science (e.g., medicine, biology, chemistry, biochemistry, pharmacy).

Experience

•    Demonstrated experience of at least 3 years in a job position managing research, collaborations or projects (can include clinical trials) in the biomedical field; and
•    Demonstrated expertise of at least 3 years in performing critical reviews in the biomedical field (e.g. scientific literature review, scientific report writing, article peer review, project evaluation, technology transfer).
    

Skills & Knowledge

•    Thorough knowledge of the landscape of actors and activities in the translational life cycle from researchers to patients; 
•    Thorough knowledge of the English language including for writing reports; 
•    Organisational skills;
•    Critical review and drafting of scientific and regulatory documents;
•    Communication and presentation skills including of scientific or regulatory matters at a high level to different audiences;
•    Proficient in using MS Office applications;
•    Understanding of the EU pharmaceutical legislation and the regulatory framework for medicinal products in the EU.
 

Nice to have

Education
PhD in Medicine or Life sciences.

Field of study
Scientific background relevant to perform the role.

Experience
•    Programmatic data collection and analysis;
•    Experience in technology transfer; 
•    Clinical experience in a therapeutic field;
•    Non-clinical experience;
•    Pharmaceutical development experience;
•    Medicines assessment at a National Competent Authority;
•    Experience in working with stakeholder organisations.

Skills & Knowledge
•    Knowledge of typical issues in quality, non-clinical, or clinical development in one or more therapeutic areas;
•    Knowledge of methodology for quality, non-clinical, or clinical development;
•    Knowledge of at least one area relevant for quality, non-clinical, or clinical development of medicines.