SNE/Scientific Specialist in Regulatory science and academia Workstream (TRS-ACD)

About this position:

The European Medicines Agency (‘the Agency’) is a decentralised body of the European Union based in Amsterdam, The Netherlands. Its core responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines. There is currently an opportunity for a Seconded National Expert to work for the Regulatory Science and Academia workstream, under the Regulatory Science and Innovation Taskforce and will deliver through collaboration with external stakeholders and across the European Medicines Regulatory Agencies Network. 

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The position is for a Science manager for the HMA/EMA European platform for Regulatory science research. The platform is part of the systematic approach to continually address scientific issues and knowledge gaps in order to facilitate research and method development for human and veterinary medicines.

In this role you will:

In respect of the European platform for Regulatory science research (https://www.ema.europa.eu/en/about-us/what-we-do/regulatory-science-research/european-platform-regulatory-science-research), you will:

• Coordinate internal- and external-facing platform activities;
• Curate scientific topics of the platform, including obtaining and reviewing inputs from stakeholders;
• Prepare scientific topics and their framing for discussions in the platform;
• Organise and potentially chair steering group meetings and kick-offs of temporary working groups;
• Organise platform meetings, including attracting contributors, reviewing participant applications, contributing to defining sought outcomes, reporting on meetings and, as applicable, contribute scientifically and through session chairing to platform meetings;   
• Contribute to create deliverables including regular reports, presentations and other outputs;
• Support the regulatory and wider translation of new drug development tools (including novel methodologies) and methods;
• Collaborate within the EMA and with the platform chairs, including for improving operations, increasing engagement, preparing topics and strengthening impact. 

Apply if you meet these eligibility requirements:

• You are national of an EU or EFTA Member State or a candidate country as decided by the Council;
• You have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (B2 level);
• You are currently  employed in the public sector (such as a university, research institute, public hospital or regulatory body) in a European Union (EU) Member State, the European Free Trade Area (EFTA), candidate countries and public intergovernmental organisations (IGOs).

You will also need to have:

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. biology, chemistry, biochemistry, pharmacy).

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Experience

• At least 3 years from the time when a university degree was awarded on completion of a minimum of three years of study;

• 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:

• • the scientific or regulatory aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines
  • working with medicinal products containing medical devices and associated regulatory framework;

You need to have:

Skills & Knowledge

• Organisational skills;
• Communication skills;
• Engagement or change management skills;
• Critical analysing, review and drafting of scientific and regulatory documents;
• Presenting scientific, or regulatory matters at a high level (including experts);
• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU;
• Knowledge of the typical issues in quality, non-clinical, or clinical development in one or more therapeutic areas;
• Knowledge of general methodology for quality, non-clinical, or clinical development;
• Knowledge of at least one area relevant for quality, non-clinical, or clinical development of medicines.

Nice to have:

Education

• PhD in a relevant field of study (Medicine or Life sciences);

Field of study

• Scientific background relevant to perform the role.

Experience

• Data analysis and knowledge management;
• Clinical research experience in a therapeutic field;
• Pharmaceutical development experience;
• With medicines assessment at a National Competent Authority;
• Regulatory scientist/product manager experience;
• Non-clinical research experience.