Medical Expert / Clinical Research Physician (m/f)

REFERENZNUMMER:

313643/9

IHRE AUFGABEN:

-Development of general medical and scientific strategies for the clinical development of new substances, medical devices and indications
-Writing of global clinical development plan (CDP)
-Assist in the implementation of clinical studies from a medical-clinical point of view and create clinical study protocols and clinical study reports according to ICH guidelines
-Write (together with co-authors) the medical section of the regulatory key documents, such as CTD, IND etc.
-Responsibility for the medical section of scientific consultation meetings, and provide medical-scientific input when assessing licensing opportunities
-Make a significant contribution with respect to developing and improving internal processes (workshops, task forces etc.)
-Present the research findings at internal and external events/congresses and publish these results

IHRE QUALIFIKATIONEN:

-A university degree in medicine with PhD or comparable scientific qualification
-Profound experience in clinical research and drug development
-Knowledge of GCP, ICH, AMG, CFR and other relevant guidelines
-Practical experience in monitoring quality and compliance in accordance with internal and external regulations, as well as in independently drafting study protocols and final reports
-Team player qualities and conflict resolution skills
-Excellent oral and written communication skills in German and English
-Willingness to travel (internationally) and experience in using MS Office

WEITERE QUALIFIKATIONEN:

Medical writer, R&D scientist, Clinical project manager