SNE/Scientific Specialist (Pharmaceutical)

TL;DR

SNE/Scientific Specialist (Pharmaceutical): Strengthening support for clinical trials and the EU clinical trials environment with an accent on regulatory, scientific, and operational activities. Focus on optimizing the Clinical Trials Information System (CTIS), supporting the Clinical Trials Coordination Group (CTCG), and conducting data analysis for the European Medicines Regulatory Network (EMRN).

Location: Amsterdam, Netherlands. Must be a citizen of an EU Member State, Iceland, Liechtenstein, Norway, Republic of Moldova, or Ukraine, and currently employed in the public sector. Hybrid work (teleworking) is available.

Company

The European Medicines Agency (hirify.global) is a decentralized body of the European Union responsible for the protection and promotion of public health through the evaluation and supervision of medicines.

What you will do

• Support the day-to-day activities of the CTCG, including coordination of FAST-EU and pre-CTA consolidated advice processes for multinational clinical trials.
• Contribute to the development and optimization of CTIS, defining business requirements for new functionalities introduced by the Biotech Act.
• Participate in the implementation of ACT EU initiatives and cross-network projects aimed at improving the EU clinical trials landscape.
• Support communication, stakeholder engagement, and change management activities to promote the use of CTIS and ACT EU initiatives.
• Conduct data analysis to provide insights that inform stakeholder needs and decision-making across hirify.global and the EMRN.

Requirements

• Citizen of an EU Member State, Iceland, Liechtenstein, Norway, Republic of Moldova, or Ukraine.
• Currently employed in the public sector (national, regional, or local public administration) in an EU Member State.
• University degree (minimum 3 years) in Life Science (e.g., biology, chemistry, biochemistry, pharmacy).
• At least 3 years of experience in medicines regulation, the pharmaceutical industry, national ethics bodies, or healthcare/academic settings.
• English: C1 level required; satisfactory knowledge of another official EU language (B2 level) is required.
• Knowledge of EU pharmaceutical legislation and the regulatory framework for pharmaceutical products.

Nice to have

• Master's degree in Medicine, Life Sciences, or Regulatory Science/Affairs.
• Experience in information analysis, reporting on scientific/regulatory matters, or clinical experience in a therapeutic field.
• Knowledge of data collection and analysis tools, including those with Artificial Intelligence components.
• Experience preparing or reviewing clinical trial application dossiers or scientific advice applications.

Culture & Benefits

• Meaningful work contributing to the health of every individual and animal in Europe.
• Development opportunities including internal mobility, mentoring, and peer coaching.
• Strong work-life balance with flexible working arrangements and teleworking options.
• Relocation assistance, comprehensive health insurance, and social benefits.
• Retirement Pension Plan and generous annual leave.

Hiring process

• Initial assessment based on the application form.
• Assessments consisting of interviews and, in some cases, a written test.
• Final selection by the Selection Committee and recommendation to the Executive Director.