05.06.24 | Vollzeit | Ludwigshafen am Rhein | AbbVie Deutschland GmbH & Co. KGDevOps, Regulatory Affairs, Medical Safety, and Operations) to ensure early involvement of global key decision makers and prepare for aligned decision-making • Ensure that GMP requirements are well understood in R&D development teams, facilitate education where required • Ensure quality and safety of IMP
Später ansehen07.06.24 | Vollzeit | Ludwigshafen am Rhein | AbbVie Deutschland GmbH & Co. KGInvolvement of global key decision makers and prepare for aligned decision-making Ensure that GMP requirements are well understood in R&D development teams, facilitate education where required Ensure quality and safety of IMP. Ensure compliance of IMP pharmaceutical drug and drug/device combination products
Später ansehen07.06.24 | Vollzeit | Ludwigshafen am Rhein | AbbVie Deutschland GmbH & Co. KGInvolvement of global key decision makers and prepare for aligned decision-making Ensure that GMP requirements are well understood in R&D development teams, facilitate education where required Ensure quality and safety of IMP. Ensure compliance of IMP pharmaceutical drug and drug/device combination products
Später ansehen07.06.24 | Vollzeit | Ludwigshafen am Rhein | AbbVie Deutschland GmbH & Co. KGDevOps, Regulatory Affairs, Medical Safety, and Operations) to ensure early involvement of global key decision makers and prepare for aligned decision-making • Ensure that GMP requirements are well understood in R&D development teams, facilitate education where required • Ensure quality and safety of IMP
Später ansehen05.06.24 | Vollzeit | Ludwigshafen am Rhein | AbbVie Deutschland GmbH & Co. KGRegulatory Affairs, Medical Safety, and Operations) to ensure early involvement of global key decision makers and prepare for aligned decision-making Ensure that GMP requirements are well understood in R&D development teams, facilitate education where required Ensure quality and safety of IMP. Ensure
Später ansehen05.06.24 | Vollzeit | Ludwigshafen am Rhein | JobLeads GmbH | 100.000 € - 125.000 € Total QA department members. Directly responsible for the effective organization, administration, training, and supervision of the Product Development Quality Organization - Drive drug development project implementation via roles on the CMC Team or other cross-functional product sub-teams as needed
Später ansehen06.06.24 | Vollzeit | Ludwigshafen am Rhein | BioNTech SEGRAPH, SQL Solid understanding of FDA, EMA, ICH and global regulations and industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards Expertise in the requirements and technology required to support electronic submissions Experience in leading
Später ansehen06.06.24 | Vollzeit | Ludwigshafen am Rhein | BioNTech SEGRAPH, SQL Solid understanding of FDA, EMA, ICH and global regulations and industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards Expertise in the requirements and technology required to support electronic submissions Experience in leading
Später ansehen06.06.24 | Vollzeit | Ludwigshafen am Rhein | BioNTech SEIncluding scientific publications Experience in leading to health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions, including developing ISE/ISS packages Very good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive
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