31.05.24 | Vollzeit | München | Daiichi Sankyo Europe GmbHMay act as clinical study leader (CSL) Study Planning and Execution - Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Leads protocol development and ICF creation; Oversees recruitment
Später ansehen23.05.24 | Vollzeit | München | Daiichi Sankyo Europe GmbHReports (PSURs/DSURs) for designated products - Provide mentoring and management development of junior physicians and scientists for their increase in expertise and compentcies - Engage with global and cross functional to manage safety profiles - Chair SMT meetings, and represent CSPV in cross-functional
Später ansehen28.05.24 | Vollzeit | Pfaffenhofen an der Ilm | Daiichi Sankyo Europe GmbHAnd international regulatory requirements. Furthermore, you support other DS functions as an expert in quality related topics and processes and support the global organization in product oversight. - Manage quality oversight at CMOs - You are responsible for quality related topics like change control, deviations
Später ansehen27.05.24 | Vollzeit | Pfaffenhofen an der Ilm | Daiichi Sankyo Europe GmbHAs the primary contact for all quality related topics at contract manufacturing organizations (CMOs). As QM CMO you manage the quality oversight at the CMOs and your responsibilities include implementation and maintaining of DS quality standards (GMP/GDP) and regulatory requirements at external contract
Später ansehen26.05.24 | Vollzeit | München | Daiichi Sankyo Europe GmbHWith Daichi Sankyo Europe (DSE) Country Managers, Medical Directors and Regulatory, Clinical Development, Clinical Sciences, Regulatory, Biostats, Data Management, and other key stakeholder peer functions to ensure strong collaboration and early operational input into study design and trial delivery planning
Später ansehen22.05.24 | Vollzeit | München | Daiichi Sankyo Europe GmbHInsights - Understanding of Medical Operational Excellence, business acumen - Hands-on mentality, can-do attitude, excited by change and new opportunities - Ability to manage several complex tasks at the same time - Excellent didactic, inter-personal and communication skills - Strong, cross-functional team
Später ansehen21.05.24 | Vollzeit | München | Daiichi Sankyo Europe GmbHInternal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products. - Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle
Später ansehen29.05.24 | Vollzeit | Pfaffenhofen an der Ilm | Daiichi Sankyo Europe GmbHSenior Quality Manager CMO (m/f/x) Purpose of the function In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs) involved in the manufacturing of small molecules. You manage the quality oversight at the assigned CMOs, which
Später ansehen29.05.24 | Vollzeit | Pfaffenhofen an der Ilm | Daiichi Sankyo Europe GmbHSenior Quality Manager CMO (m/f/x) - Drug Product Manufacturing Purpose of the function In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs). As QM CMO you manage the quality oversight at the CMOs and your responsibilities
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