Senior Scientific Specialist

About this position

Public Health Threats Department (AF-HT) is looking for a Senior Scientific Specialist to support and manage high-impact activities, including preparedness and response to biological threats. In this role, you will contribute to the development and operation of the European Medicines Agency (EMA)’s Emergency Task Force and the activities of the AF-HT department. In particular, you will be responsible for clinical and preclinical input in the context of specific virological health threats from basic science to medical countermeasure development, evaluation and monitoring.

You will also contribute to EMA’s extended mandate and leading role with regards to declared or potential public health threats, supporting the development and evaluation of medicinal products including vaccines, therapeutics and diagnostics, and provide input with respect to specific virological aspects. The set of tasks to be covered includes collaboration with ECDC, WHO and clinicians, together with support to ETF including assessment of scientific advices.

In this role you will:

• Provide scientific coordination and input in relation to the development, evaluation and surveillance of medicinal products for human use addressing viruses of epidemic and pandemic potential;
• Contribute to virological surveillance and horizon scanning of emerging scientific evidence;
• Contribute to scientific advice, pipeline review and maintenance, qualification of methodology for medical countermeasures addressing viral diseases;
• Provide scientific input to developers of medicines addressing a public health emergency and to the Emergency Task Force;
• Support the activities of the ETF including organisation of workshops and guidelines development;
• Provide training as required;
• Apply EU pharmaceutical legislation to the operations of the Agency as required;
• Represent the Agency in external meetings and contribute to EU and global activities related to emerging viral diseases;
• Respond to the requests for information received by the EMA in the scientific field.

Eligibility criteria

General conditions:

1. Enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2. Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3. Have fulfilled any obligations imposed by applicable laws concerning military service.

Specific conditions:

Possess a university degree in the field of Medicine or Life Sciences (biology, micro-biology, biochemistry, pharmacy) that must have been obtained by the closing date of this vacancy notice, and relevant professional experience after obtaining the relevant degree (also obtained by the closing date), in the field of the above-mentioned areas and duties, as follows:

• Minimum 4-year degree plus at least 9 years’ relevant professional experience; or
• Minimum 3-year degree plus at least 10 years’ relevant professional experience.

You will also need to have:

Experience

At least 5 years of experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting, obtained in any of the following areas:

• Virology;
• Antiviral medicines;
• Clinical practice in the context of viral diseases;
• In vitro diagnostics for viral diseases.

Skills & Knowledge

• Ability to review, interpret, and draft complex scientific and regulatory documents in a clear and audience appropriate manner;
• Ability to presenting scientific, or regulatory matters at a high level (eg to experts);
• Knowledge and understanding of EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU, including ICH guidelines relevant to the role, or the ability to acquire and apply such knowledge quickly;
• Knowledge and understanding of current legislation and guidance in the relevant area of expertise, or the ability to rapidly develop, interpret, or the ability to acquire and apply such knowledge quickly.

Competencies you will need to have:

Role competencies

• Scientific evidence management – Intermediate
• Influencing and persuading – Advanced
• Prioritising and organising – Advanced

Sub-family competencies

• Regulatory Framework and Strategy - Advanced
• Applied knowledge - Advanced

Grade competencies

• Adaptability and agility – Intermediate
• Coping with pressures and setbacks – Advanced
• Analysing and problem solving – Advanced

Core competencies

• Ethics and integrity – Intermediate
• Team collaboration - Advanced
• Customer centricity - Advanced
• Results orientation - Advanced
• Communication - Advanced
• Cross-cultural sensitivity - Advanced
• Continuous learning and self-development - Intermediate

These are considered nice to have:

Education

• PhD in virology or infection diseases

Experience

• In information analysis and reporting on scientific/ regulatory matters;
• In researching, analysing and presenting scientific data including scientific writing;
• In working for a regulatory body, clinic or medical organisation, academic institution or similar, in medicines development;

Skills & Knowledge

• Knowledge of legal, regulatory and procedural aspects of EU Medicines Regulatory framework;
• Knowledge of general methodology for quality, non-clinical, or clinical development;
• Knowledge of trends and innovative developments in pharmaceutical manufacturing and bordering legislation (e.g. medical devices);
• Knowledge of analytical methods and research skills.

What do we offer?

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)

Benefits

• Initial 5 year contract with competitive monthly tax-free salary and household & children’s allowances (where applicable)
• Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
• Relocation assistance
• Excellent health insurance scheme and social benefits
• Retirement Pension Plan

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates. The successful candidate(s) will be required to relocate to the Netherlands to pick up duties.