Collaborating Expert on data analysis and predictability of MAAs submissions

Organizational Unit: Regulatory Science and Innovation Task Force 

                                   Innovation and Development Accelerator Office

Place of work: Flexible (occasionally on EMA premises and remote).

The position is part time. The successful candidate will be able to dedicate a minimum of 20 hours per week to the collaboration.

Proposed length: 6 months(extendable if needed). 

Remuneration: Experts should be salaried by their employer or be a post-graduate student (financed by their educational entity or self-financed). 

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters 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.

The Collaborating Expert Programme is addressed to scientists and professionals who can share their expertise in a particular area of European Medicines Agency’s activities or are interested in collaborative research projects related to EMA’s scientific work.

The aim is to provide a mechanism for EMA and external researchers to collaborate in identifying and tackling important research questions to support regulatory decision-making.

This will help ensure that regulatory science remains at the cutting edge so that EMA can deliver its fundamental mission of protecting human and animal health and facilitating the availability of medicines to patients.

This announcement is governed by the Policy 0080. For further information please visit our Collaborating Expert Programme website.

Strategic area / objective

European Medicines Agencies Network Strategy to 2025 - Strategic focus area 6 - Sustainability of the Network and operational excellence

Specific projects

•    Analyse data of MAAs pipeline, its trends and common features
•    Analyse factors affecting submissions predictability
•    Develop data models and tools to improve submissions predictability
•    Propose measures to improve submission predictability and availability of innovative medicines
 

Deliverables

•    Report summarising findings including trends and key factors affecting predictability of submissions
•    New forecast report structure according to findings
•    Presentations of data analysis results internally to EMA respective Network entities
•    Publish the outcome in a peer reviewed journal
 

Benefits for the expert

•    Gain experience of working in an EU organisation and of the EMA’s work and role in regulatory science 
•    Learn about pharma pipeline and EMA support to innovative medicines
•    Gain experience in a rapidly changing area of regulatory science enabling development of novel medicines and technologies
•    Contribute to the European Medicines Agencies Network preparedness
 

Benefits for the collaborating institution

•    Insight in pharmaceutical R&D pipeline and exchange of knowledge and expertise 
•    Joint research undertaking, and if publication, joint publication
•    Building a personal and inter-institutional collaboration with EMA
 

Essential requirements

Eligibility criteria:  
•    Be an EU or EEA national
•    Meet the requirements stated in the profile description;
•    Be a paid employee from European academia, research institutions, public sector or international organisations, or a post graduate student within such organisations. Proof of employment/student status and agreement in principle of employer/academic institution will be requested.;
•    Have a thorough knowledge of English (at least level C1). Good knowledge of another official EU language (at least B2) is an asset, as per the Common European Framework for Languages.

University degree(s)

Essential: Minimum of a university degree in biomedical sciences
Desirable: Higher degree in biomedical or health social sciences (MSc or PhD) including data analysis
 

Experience and additional skills

Essential: at least 2 years of work experience in data management/data analytics; research and analytical skills; excellent written communication skills; knowledge in data analytics and data management

Desirable: knowledge in health/pharma sciences; basic knowledge of the EU regulatory aspects related to the medicinal product and/or medical device lifecycle; demonstrated experience in the field of data collection; demonstrated experience in writing, analysis and reporting of results
 

Behavioural competencies

Essential: Communication skills; Interpersonal skills; Working with others; Adaptability; Learning and development

______________________________________________________________________________________________________

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

© European Medicines Agency, 2024. Reproduction is authorised provided the source is acknowledged.