08.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 80’000 - CHF 100’000 The "Submit" button you consent to receive emails about similar jobs. You agree to the Terms of Use and acknowledge Danaher's Data Privacy Policy . You may easily unsubscribe at any time. Get tailored job recommendations based on your interests. Please be aware that fraudsters often impersonate
Später ansehen08.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 100’000 - CHF 125’000 Audit - inspection reports, CAPA and collection of supportive evidences in FKSBS Clinical QA database. Quality Management System - Collaborate with the SOP Steering Committee and Clinical Development representatives to review Global - FKSBS SOP applicability, deployment, effectiveness and compliance
Später ansehen08.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 100’000 - CHF 125’000 The applicable regulatory requirements. Review and analysis of data for same - Review & analysis of adverse event/complaint information as required - Support and review of Clinical Evaluation Plans and Clinical Evaluation Reports - Lead a multidisciplinary team to ensure the site conduct comprehensive searches
Später ansehen08.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 100’000 - CHF 125’000 Business needs and ensure compliance with the regulatory systems. - Execute the CMC RA Strategy for assigned projects. - Manages submission CMC related documents for assigned Biosimilars. - Translate CMC data in regulatory CMC positioning, to create a comprehensive story line. - Act as Regulatory Affairs
Später ansehen08.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 100’000 - CHF 125’000 Establish report templates, review and approve study protocols and CMC and nonclinical pharmacology result reports; - Support cQA assessment and QTPP establishment for biosimilars products; - Assess the overall similarity of the products’ biological activity; - Assess product analytical quality data for its
Später ansehen08.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 125’000 - CHF 150’000 But not essential PERSONAL SKILLS & COMPETENCIES - Technical leadership and influencing skills - Ability to critically evaluate scientific data obtained at different stages of development - Strong analytical skills to drive teams to deliver - Ability to work on multiple projects concurrently and flexibility
Später ansehen07.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 80’000 - CHF 100’000 By clicking the "Submit" button you consent to receive emails about similar jobs. You agree to the Terms of Use and acknowledge Danaher's Data Privacy Policy . You may easily unsubscribe at any time. Please be aware that fraudsters often impersonate companies like Danaher and our operating
Später ansehen07.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 100’000 - CHF 125’000 Operational challenges, GCP compliance, and standardization in collaboration with cross functional colleagues according to the level of expertise. - Effectively collaborate with Biostatistics, Programming and Data Management colleagues as well as with Pharmacometrician for input and information exchange
Später ansehen07.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 80’000 - CHF 100’000 Partner with the Product and the Marketing teams to organize new products introductions. Ensure launches readiness from commercial, operations and marketing aspects (Readiness of Assets, PoS materials, production, master data, pricing, etc.) - Handle all portfolio evolutions as projects, lead cross
Später ansehen01.01.21 | Vollzeit | Eysins | JobLeads GmbH | CHF 80’000 - CHF 100’000 Verification and validation protocols and reports. - Perform and Review of laboratory and cleanroom data including environmental monitoring, microbiology testing (air, water, filters and surfaces…) - Assist in designing of monitoring and testing programs and strategically evaluate processes for improvements
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