SNE/Scientific Specialist

3 maanden geleden

Amsterdam, Nederland The European Medicines Agency (EMA) Voltijd

SNE/Scientific Specialist (Labelling)

Type of position: Seconded National Expert Job Type: 30 September 2024 at 23:59 CET

Type of position : Seconded National Expert 

Job title : SNE/Scientific Specialist (Labelling)

Deadline for applications : 30 September 2024 at 23:59 CET 

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 health through the evaluation and supervision of medicines.

We are looking for National experts on secondment. This means staff from other European public-sector bodies can work at the European Medicines Agency (EMA) for short periods of time through the national expert on secondment (SNE) programme. The aim of this programme is to enhance and develop the relationship between European public administrations.

SNEs serve a dual role: they bring their expertise to EMA and take back to their home administration the knowledge acquired during their period of secondment. SNEs remain in the service of their employer. Secondment is not equivalent to employment, nor does it lead to employment by EMA. Periods of secondment may last between six months and two years. This is renewable once or more, up to a total of four years.

About this position

At the European Medicines Agency, you will provide your subject matter expertise in the review of product information (Summary of Product Characteristics, Labelling and Package leaflet) of medicinal products across the medicine life-cycle, contributing to the development support and evaluation activities. You will primarily provide regulatory and scientific support to the Quality Review of Documents (QRD) working group, bringing to their attention issues that require decision-making at a centralised level and coordinating their input in the review of the product information. Furthermore, you will provide cross-therapeutic advice to ensure scientifically robust and technically consistent labelling, including aspects related to product naming and use of new digital technologies on the final packaging and/or package leaflet, and contribute to the identification of known or emerging issues to prevent potential medication errors. 

In this post you will

Manage the labelling review and standards check of product information for new applications, line-extensions and renewals, for some categories of human products assigned via ATC codes; Support to the SmPC Advisory Group activities, including drafting of advice to ad-hoc requests related to the interpretation of the SmPC guideline and advice to assessors and the Agency’s scientific staff on all matters relating to the SmPC guideline; Prepare and participate in the QRD and NRG (Name Review Group) plenary meetings; Provide support to the Mock-ups and Specimen review process; Contribute to the overall compliance and consistency in product information standards, by participating in Agency stakeholders’ interactions and consultations, advising on how to improve regulatory information based on the regulatory framework, and how to ensure consistency between the SmPC, Package leaflet and labelling.

Provide scientific coordination and regulatory and/or procedural support in relation to any of the following areas:

Development, evaluation and surveillance of medicinal products for human use; The delivery of high-quality product information through assessment of invented names, product information and its translations, mock-ups and specimens, and provision of advice and training on product information guideline principles; Apply EU pharmaceutical legislation to the operations of the Agency as required; Lead the development of regulatory and/or procedural guidance documents and provide training as required; Respond to requests for information received by the EMA in the field of responsibility.

Apply if you have these eligibility criteria

Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;  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); Be currently employed in the public sector (such as an public intergovernmental organisation (IGO) national / regional / local public administration / a university /academic institution) in a European Union (EU) Member State and for the foreseeable time of the tenure as SNE remain in such employment.

Communication and professional contacts

The SNE is required to regularly communicate (verbally and in writing) information, which requires careful explanation and interpretation, taking into account what to communicate and how best to convey the information. Writing and creating information that is specialist, sensitive, confidential, legal and/or regulatory in nature.


Regular professional contacts with others inside and/or outside the Agency on functional matters. Solicits/gives information, provides advice/guidance and should use initiative. A likely requirement is to influence others’ thinking and negotiate with various parties within own job responsibilities. Normally connected to the Agency's core business or a project.

In particular, a Labeling Specialist will:

Liaise with internal and external stakeholders and interested parties, internal and external subject experts; Coordinate, support, lead effective communication and relations; Daily internal communication and interaction related to the management of the procedures with other colleagues across the Agency and the extended product team members; Contribute to the preparation of Scientific Committee meetings, Working Parties, Working Groups, including providing scientific support as applicable.

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. biology, chemistry, biochemistry, pharmacy, medicine).

Experience

3 years from the time when a university degree was awarded on completion of a minimum of three years of study; Experience in medicinal product life-cycle management, with a particular focus on the review of product information from a regulatory and scientific perspective; Sound knowledge of the regulatory and legal framework applicable to the work of the Labelling Office;  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:  In the scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human medicines; In working with medicinal products containing medical devices and associated regulatory framework;  In real clinical practice (e.g. hospital/community pharmacist), including prescription, dispensing, preparation and handling of medicines.

Skills & Knowledge

Organisational skills; Communication skills; Critical review and drafting of scientific and regulatory documents for expert and lay audiences; Presenting scientific or regulatory matters; Proficient in English language; Proficient in MS Office suite; 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.

Nice to have

Education

Masters in a relevant field of study (Medicine or Life sciences);  Master’s degree in regulatory science and/or affairs.

Field of study

Scientific background relevant to perform the role.

Experience

Excellent communication skills with experience of working with numerous external stakeholders to achieve outcomes; Strong organisational skills with the ability to work to demanding deadlines; A strong sense of team collaboration and willingness to support colleagues across the whole team; Proactive approach in identifying and handling issues arising within the performance of labelling review tasks; Excellent case management skills with the ability to manage competing priorities effectively; Proven document management skills with excellent attention to detail; Customer oriented mindset; Can-do approach with effective problem-solving skills; In information analysis and reporting on scientific/regulatory matters; Clinical experience in a therapeutic field; Pharmaceutical development experience; With medicines assessment at a National Competent Authority; Regulatory scientists/product manager experience; Non-clinical experience; Experience in working with stakeholders (industry and national/international authorities).

Skills & Knowledge 

Understanding of medicines regulation.

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