We are looking for our HZG 1 area at the next time Senior Consultant (m/w/d) We, the Paul-Ehrlich-Institut, are a scientific institution of the federal government which is responsible for the testing and approval of vaccines and biomedical medicines and operates research in the field of life sciences. Networking with national and international actors makes us a competent contact for the public, science, medicine, politics and business. The Department of Haematology, Cell and Gene Therapy will accompany all steps in the life cycle of the medicines it provides through scientific advice, approval of clinical trials and approval. This is supplemented by the state batch testing and release as a prerequisite for the placing on the market of blood products after approval and inspections.

The subject area “Review Clinic Hematology, Cell and Gene Therapy” evaluates the clinical and non-clinical investigations of all medicines within the competence of the Department of Hematology, Cell and Gene Therapy within the framework of all national and European regulatory procedures.

We are looking for the assessment of non-clinical aspects of applications for clinical trials and market authorisations and the decision on their suitability for approval. This role covers the evaluation of new biological products, including new active substances, at various stages of development and indications. The reports and recommendations to be submitted have a great influence on whether the testing of new medicines can be started and whether new medicines can be made available for patients in general.

Assessment of applications for approval of clinical trials or market authorisation at national and European level Advising companies and scientists in the development, production and testing of medicinal products in the field of competence Cooperation in the preparation of scientific recommendations for developers and pharmaceutical manufacturers under the Scientific-Advice procedure of the European Medicines Agency EMA Cooperation in the development of regulatory guidelines and the establishment of criteria and standards for the development and evaluation of new innovative drug candidates, such as genomic drug candidates

Completed academic studies (master or comparable) in the field of natural sciences, preferably biosciences, with scientific doctorate Molecular biological/cell biological and/or virological knowledge Interest in drug development and regulation issues Safe handling of Microsoft Office, databases and modern data communication Ability to work independently and independently Quick understanding and analytical understanding of complex scientific contexts Impressed team skills and willingness to participate in in interdisciplinary teams Very good work organization, high loadability and flexibility Very good English language skills in word and writing Please note that a Declaration of Interests vis-à-vis the EMA as well as a statement in accordance with § 77a AMG must be delivered when the contract is concluded.

is a versatile and demanding workplace centrally located in the Rhine-Main area with good connections to the public transport network (car, airport, S-Bahn). As an employer of the public service, we offer the usual social benefits such as special payments for the year, pensions for the enterprise and benefits in terms of assets.

The employment relationship is limited to three years. Parttime employment is possible in principle. The service post is rated according to E 14 TVöD, part I of Appendix 1 of the TV EntgO Bund. The assignment to the stages takes place taking into account the personal relevant experiences. Disabled applicants (m/w/d) are preferably taken into account with the same suitability. The Paul-Ehrlich-Institut promotes equality between people and the reconciliation of family and work. For this purpose, we offer, inter alia, very flexible working hours (part-time models, no core working hours), hybrid work (max. 60% remote), kindergarten places and numerous training opportunities. Our occupational health management and the promotion of the job ticket complete the offer. .