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Ensuring clinical studies are conducted according to the study protocol, SOPs, ICH/GCP regulations, and study-specific manuals and procedures; Participating in the development of...
This position is responsible for the study-level management (prior to submitting to IRB/EC to closeout) of clinical studies, including preparation of applicable clinical study...
Responsible for access and governance of all data asset for the medical and clinical data science team; Support operating model and change management considerations for data...
Independently prepare Patient Safety Narratives, Patient Lay Summaries, patient consent forms and dossier related documentation (such as Clinical summaries, Briefing Books, PDCO...