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- Praxismanagement
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12 Treffer für Clinical Development Associate Jobs
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Associate Director Regulatory Affairs – Clinical Lead*
Associate Director Regulatory Affairs – Clinical Lead*
Immatics Biotechnologies GmbH
Tübingen, München, Home-Office
Teilweise Home-Office
We are currently seeking an Associate Director Regulatory Affairs – Clinical Lead* to strengthen our EU Regulatory team. In this role, you will take ownership of EU regulatory strategy and execution for innovative oncology biopharmaceutical programs, including ATMPs, across early and late-stage development. You will independently lead EU regulatory activities for assigned clinical programs and act as a key driver of regulatory strategy and execution. * Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization. * Drive initial clinical trial application and its lifecycle management, including major Substantial Modifications, with a proactive and risk-based mindset. This includes preparation, review and maintaining documentation of clinical trial applications.
We are currently seeking an Associate Director Regulatory Affairs – Clinical Lead* to strengthen our EU Regulatory team. In this role, you will take ownership of EU regulatory strategy and execution for innovative oncology biopharmaceutical programs, including ATMPs, across early and late-stage development. You will independently lead EU regulatory activities for assigned clinical programs and act as a key driver of regulatory strategy and execution. * Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization. * Drive initial clinical trial application and its lifecycle management, including major Substantial Modifications, with a proactive and risk-based mindset. This includes preparation, review and maintaining documentation of clinical trial applications.
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As the Clinical Product Education Team, we are responsible for learning activities associated to MED-EL products and services. * +3 years of relevant hands-on clinical experience in hearing implants, with a dedication to being informed about the latest developments and a strong passion for educating other professionals * Demonstrated ability to convey complex clinical concepts in a clear and understandable manner * Manage the planning and execution of training programs for professionals using MED-EL's technology, emphasizing complex concepts and clinical procedures * Build expertise in all competitive hearing implant systems and demonstrate a deep understanding of MED-EL's product portfolio and complex clinical concepts * Determine training requirements, identify ways for ongoing improvement, and advance the impact and effectiveness of training and competency development
As the Clinical Product Education Team, we are responsible for learning activities associated to MED-EL products and services. * +3 years of relevant hands-on clinical experience in hearing implants, with a dedication to being informed about the latest developments and a strong passion for educating other professionals * Demonstrated ability to convey complex clinical concepts in a clear and understandable manner * Manage the planning and execution of training programs for professionals using MED-EL's technology, emphasizing complex concepts and clinical procedures * Build expertise in all competitive hearing implant systems and demonstrate a deep understanding of MED-EL's product portfolio and complex clinical concepts * Determine training requirements, identify ways for ongoing improvement, and advance the impact and effectiveness of training and competency development
Create, edit, and proofread Clinical Evaluation Reports and associated documents to assess the safety and performance of a range of MED-EL products, in accordance with applicable regulations - Research & Development * Oversee the planning, execution, and maintenance of clinical evaluation activities to ensure compliance with regulatory requirements and company standards * Collate and analyze clinical data from clinical trials and testing, scientific literature, and post-market experience * Understanding of, and enthusiasm for scientific working, medical technology, and clinical research
Create, edit, and proofread Clinical Evaluation Reports and associated documents to assess the safety and performance of a range of MED-EL products, in accordance with applicable regulations - Research & Development * Oversee the planning, execution, and maintenance of clinical evaluation activities to ensure compliance with regulatory requirements and company standards * Collate and analyze clinical data from clinical trials and testing, scientific literature, and post-market experience * Understanding of, and enthusiasm for scientific working, medical technology, and clinical research
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Schnelle Bewerbung
Coordinate and collaborate with cross-functional teams, including Data Management, Clinical Research Associates (CRAs), and other relevant internal stakeholders * Contribute to continuous process improvement initiatives, including SOP development and implementation of best practices in clinical operations * Strong background in clinical development for implantable or other high-risk (Class III) medical devices preferred - To enlarge our Clinical Programs EMEA team we are looking as soon as possible for a * Lead the end-to-end management of clinical studies for Class III medical devices, from feasibility assessment through study close-out * Develop, maintain, and track clinical project plans, timelines, budgets, and risk management strategies * Ensure all clinical studies are conducted in compliance with GCP (ISO 14155), EU MDR, and applicable local regulatory requirements
Coordinate and collaborate with cross-functional teams, including Data Management, Clinical Research Associates (CRAs), and other relevant internal stakeholders * Contribute to continuous process improvement initiatives, including SOP development and implementation of best practices in clinical operations * Strong background in clinical development for implantable or other high-risk (Class III) medical devices preferred - To enlarge our Clinical Programs EMEA team we are looking as soon as possible for a * Lead the end-to-end management of clinical studies for Class III medical devices, from feasibility assessment through study close-out * Develop, maintain, and track clinical project plans, timelines, budgets, and risk management strategies * Ensure all clinical studies are conducted in compliance with GCP (ISO 14155), EU MDR, and applicable local regulatory requirements
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We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring the successful negotiation and on-going maintenance of clinical trial agreements, complex amendments, and other ancillary agreements with study sites. ICON plc is a world-leading healthcare intelligence and clinical research organization. We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. * Drafts, reviews, negotiates, and finalizes clinical trial agreements, complex amendments, and other ancillary agreements with study sites using critical thinking, available tools/systems/documents, historical data, and adheres to departmental ...
We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring the successful negotiation and on-going maintenance of clinical trial agreements, complex amendments, and other ancillary agreements with study sites. ICON plc is a world-leading healthcare intelligence and clinical research organization. We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. * Drafts, reviews, negotiates, and finalizes clinical trial agreements, complex amendments, and other ancillary agreements with study sites using critical thinking, available tools/systems/documents, historical data, and adheres to departmental ...
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The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. * Collaborates with development and maintenance of Clinical Trial Management System (CTMS). The Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. * Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. * Collaborates with development and maintenance of Clinical Trial Management System (CTMS). The Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. * Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
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Schnelle Bewerbung
Development and implementation of the local medical strategy to support clinical practice and the objectives of the overall company. * Responsibility for the implementation of new medical practices, the evaluation of new indications, analysis of the status quo of current treatment and patient pathways, identification of patients for clinical research, and the development of a deep understanding of the respective indication area. * Disciplinary leadership of the Amyloidosis Medical Affairs team and ensuring the team's objectives are achieved through the efficient management of all directly reporting to the position and the retention of talented employees through personal development support.
Development and implementation of the local medical strategy to support clinical practice and the objectives of the overall company. * Responsibility for the implementation of new medical practices, the evaluation of new indications, analysis of the status quo of current treatment and patient pathways, identification of patients for clinical research, and the development of a deep understanding of the respective indication area. * Disciplinary leadership of the Amyloidosis Medical Affairs team and ensuring the team's objectives are achieved through the efficient management of all directly reporting to the position and the retention of talented employees through personal development support.
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * As a member of the German Corporate Affairs teams, you contribute to the development of annual patient advocacy strategy, goals and patient engagement plans, aligning within Corporate Affairs for Germany and ensure execution per therapeutic area * Conceptualize and coordinate engagement of PAOs in the development of local Patient Support Programs (PSPs) working in close partnership with the Patient Medical Program team and local medical team responsible for PSPs
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * As a member of the German Corporate Affairs teams, you contribute to the development of annual patient advocacy strategy, goals and patient engagement plans, aligning within Corporate Affairs for Germany and ensure execution per therapeutic area * Conceptualize and coordinate engagement of PAOs in the development of local Patient Support Programs (PSPs) working in close partnership with the Patient Medical Program team and local medical team responsible for PSPs
Schnelle Bewerbung
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * As a member of the German Corporate Affairs teams, you contribute to the development of annual patient advocacy strategy, goals and patient engagement plans, aligning within Corporate Affairs for Germany and ensure execution per therapeutic area * Conceptualize and coordinate engagement of PAOs in the development of local Patient Support Programs (PSPs) working in close partnership with the Patient Medical Program team and local medical team responsible for PSPs
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * As a member of the German Corporate Affairs teams, you contribute to the development of annual patient advocacy strategy, goals and patient engagement plans, aligning within Corporate Affairs for Germany and ensure execution per therapeutic area * Conceptualize and coordinate engagement of PAOs in the development of local Patient Support Programs (PSPs) working in close partnership with the Patient Medical Program team and local medical team responsible for PSPs
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Special Operations Case Manager / Nurse Case Manager (1-10 SFG(A), Baumholder, Germany)
Special Operations Case Manager / Nurse Case Manager (1-10 SFG(A), Baumholder, Germany)
Kellogg Brown & Root GmbH
Baumholder, Rhineland-Palatinate, Germany
We are seeking a stellar Special Operations Case Manager / Nurse Case Manager that will provide a full range of professional health nursing principles, practices, and procedures in clinical settings in order to analyze the full scope of problems associated with providing appropriate, cost effective care to Department of Defense (DOD) beneficiaries. * Knowledge and skills in the use of VA/DOD Clinical Practice Guidelines in order to ensure an evidence based standardized process of care to military beneficiaries. * Current licensure; full, active, and unrestricted license as a Registered Nurse or Licensed Clinical Social Worker in one of any U.S. State, the District of Columbia, Guam, Puerto Rico or U.S. Virgin Islands. * Ability to seek feedback from peers, professional colleagues, clients, and outcomes research, in order to expand clinical knowledge, enhance role performance, ...
We are seeking a stellar Special Operations Case Manager / Nurse Case Manager that will provide a full range of professional health nursing principles, practices, and procedures in clinical settings in order to analyze the full scope of problems associated with providing appropriate, cost effective care to Department of Defense (DOD) beneficiaries. * Knowledge and skills in the use of VA/DOD Clinical Practice Guidelines in order to ensure an evidence based standardized process of care to military beneficiaries. * Current licensure; full, active, and unrestricted license as a Registered Nurse or Licensed Clinical Social Worker in one of any U.S. State, the District of Columbia, Guam, Puerto Rico or U.S. Virgin Islands. * Ability to seek feedback from peers, professional colleagues, clients, and outcomes research, in order to expand clinical knowledge, enhance role performance, ...
Schnelle Bewerbung
Solid knowledge of clinical development processes. * Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. The Country Study Manager (CSM) has local responsibility for the delivery of the studies in compliance with Good Clinical Practice (GCP), and regulatory requirements. The CSM works in close collaboration with Study Start-Up (SSU) manager, Clinical Study Administrator (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The CSM is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to SOPs. The CSM will work closely with of Country Operations (HCO), and/or Associate Director Country ...
Solid knowledge of clinical development processes. * Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. The Country Study Manager (CSM) has local responsibility for the delivery of the studies in compliance with Good Clinical Practice (GCP), and regulatory requirements. The CSM works in close collaboration with Study Start-Up (SSU) manager, Clinical Study Administrator (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The CSM is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to SOPs. The CSM will work closely with of Country Operations (HCO), and/or Associate Director Country ...
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You will work closely with , , and clinical experts, to ensure our products meet stringent regulatory standards and deliver exceptional performance. * Certifications such as AWS Certified Security Specialty, CISSP Associate and TensorFlow Developer / MLflow Certification (good to have). * Opportunities for professional growth and development.
You will work closely with , , and clinical experts, to ensure our products meet stringent regulatory standards and deliver exceptional performance. * Certifications such as AWS Certified Security Specialty, CISSP Associate and TensorFlow Developer / MLflow Certification (good to have). * Opportunities for professional growth and development.
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Senior Scientist (m/f/d), Computational Pathology Biomarker Lead (BioPharmaceuticals)
Senior Scientist (m/f/d), Computational Pathology Biomarker Lead (BioPharmaceuticals)
AstraZeneca
München
Lead and collaborate with cross-functional teams to develop AI-driven biomarker signatures for target engagement, patient stratification, and early biological activity * Partner with experimental scientists to shape data generation strategies and ensure high-quality, AI-ready data * AstraZeneca * München * Feste Anstellung * Vollzeit - AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. SITE DESCRIPTION - Munich, Germany - At Computational Pathology Munich (CPM), we make a significant contribution to high-performance, data-driven research and development. Our team operates in a demanding, fast-paced environment where excellent collaboration, clear communication and ...
Lead and collaborate with cross-functional teams to develop AI-driven biomarker signatures for target engagement, patient stratification, and early biological activity * Partner with experimental scientists to shape data generation strategies and ensure high-quality, AI-ready data * AstraZeneca * München * Feste Anstellung * Vollzeit - AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. SITE DESCRIPTION - Munich, Germany - At Computational Pathology Munich (CPM), we make a significant contribution to high-performance, data-driven research and development. Our team operates in a demanding, fast-paced environment where excellent collaboration, clear communication and ...
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Specialist Regulatory Affairs für Medizinprodukte (m/w/d)
Specialist Regulatory Affairs für Medizinprodukte (m/w/d)
TRB CHEMEDICA AG
Feldkirchen b. München
Teilweise Home-Office
Schnelle Bewerbung
Für unseren Standort Feldkirchen bei München suchen wir zur Unterstützung der Abteilung Regulatory Affairs schnellstmöglich einen Specialist Regulatory Affairs für Medizinprodukte (m/w/d) * TRB CHEMEDICA AG * Feldkirchen b. München * Feste Anstellung * Homeoffice möglich, Teilzeit, Vollzeit - Schnelle Bewerbung - Mit Produkten, die sich durch Qualität und Know-how auszeichnen, hat sich das 1996 gegründete inhabergeführte Pharmaunternehmen TRB CHEMEDICA AG in den Bereichen Orthopädie und Augenheilkunde eine führende Position in der Branche erarbeitet. Die Aufgabe der deutschen Niederlassung ist die Zertifizierung der Medizinprodukte sowie der Vertrieb in Deutschland und den Benelux-Ländern. In den kommenden Jahren plant das innovative Unternehmen die Einführung wichtiger Neuerungen. Unterstützen Sie unser Team bei dieser spannenden Aufgabe! Ihre Aufgaben
Für unseren Standort Feldkirchen bei München suchen wir zur Unterstützung der Abteilung Regulatory Affairs schnellstmöglich einen Specialist Regulatory Affairs für Medizinprodukte (m/w/d) * TRB CHEMEDICA AG * Feldkirchen b. München * Feste Anstellung * Homeoffice möglich, Teilzeit, Vollzeit - Schnelle Bewerbung - Mit Produkten, die sich durch Qualität und Know-how auszeichnen, hat sich das 1996 gegründete inhabergeführte Pharmaunternehmen TRB CHEMEDICA AG in den Bereichen Orthopädie und Augenheilkunde eine führende Position in der Branche erarbeitet. Die Aufgabe der deutschen Niederlassung ist die Zertifizierung der Medizinprodukte sowie der Vertrieb in Deutschland und den Benelux-Ländern. In den kommenden Jahren plant das innovative Unternehmen die Einführung wichtiger Neuerungen. Unterstützen Sie unser Team bei dieser spannenden Aufgabe! Ihre Aufgaben
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Medical Affairs Specialist in der pharmazeutischen Industrie (m/w/d)
Medical Affairs Specialist in der pharmazeutischen Industrie (m/w/d)
Dermapharm AG
Grünwald
Teilweise Home-Office
Zur Erweiterung unseres Teams suchen wir am Standort Grünwald ab September 2026 in Teilzeit mit 16 Stunden (4 Tage) einen Medical Affairs Specialist in der pharmazeutischen Industrie (m/w/d) * Unterstützung bei der strategischen Transformation des Bereichs Medical Affairs * Dermapharm AG * Grünwald * Feste Anstellung * Homeoffice möglich, Teilzeit - WIR - Die Dermapharm AG - Die börsennotierte Dermapharm ist ein dynamisch wachsender Hersteller von patentfreien Markenarzneimitteln für ausgewählte Märkte und zählt zu den führenden Marktplayern im deutschen Pharmamarkt. Die 1991 gegründete Gesellschaft hat ihren Sitz in Grünwald bei München und ihren Hauptproduktionsstandort in Brehna bei Leipzig. Zur Unternehmensgruppe zählen Gesellschaften im In- und Ausland wie die Allergopharma GmbH & Co. KG, mibe GmbH Arzneimittel, Hübner Naturarzneimittel GmbH, Trommsdorff GmbH und die kürzlich erworbene ...
Zur Erweiterung unseres Teams suchen wir am Standort Grünwald ab September 2026 in Teilzeit mit 16 Stunden (4 Tage) einen Medical Affairs Specialist in der pharmazeutischen Industrie (m/w/d) * Unterstützung bei der strategischen Transformation des Bereichs Medical Affairs * Dermapharm AG * Grünwald * Feste Anstellung * Homeoffice möglich, Teilzeit - WIR - Die Dermapharm AG - Die börsennotierte Dermapharm ist ein dynamisch wachsender Hersteller von patentfreien Markenarzneimitteln für ausgewählte Märkte und zählt zu den führenden Marktplayern im deutschen Pharmamarkt. Die 1991 gegründete Gesellschaft hat ihren Sitz in Grünwald bei München und ihren Hauptproduktionsstandort in Brehna bei Leipzig. Zur Unternehmensgruppe zählen Gesellschaften im In- und Ausland wie die Allergopharma GmbH & Co. KG, mibe GmbH Arzneimittel, Hübner Naturarzneimittel GmbH, Trommsdorff GmbH und die kürzlich erworbene ...
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Schnelle Bewerbung
Zur Verstärkung unseres Teams in München suchen wir zum nächstmöglichen Zeitpunkt eine/n Project Manager Science Relations (m/w/d) Als Project Manager Science Relations (m/w/d) unterstützt du den Ausbau und die Pflege des wissenschaftlichen Netzwerks in der BAIOSPHERE. * BAIOSPHERE AGENCY/ Bayerische KI-Agentur * München * Befristeter Vertrag * Teilzeit, Vollzeit - Sei einer der ersten Bewerber - Schnelle Bewerbung - Vergütung nach TV-L (bis E 13) | befristet auf zwei Jahre | Voll- oder Teilzeit (mind. 80%) Die Bayerische KI-Agentur der Bayerischen Akademie der Wissenschaften vernetzt in der BAIOSPHERE führende Akteure und Projekte im Bereich Künstliche Intelligenz in Bayern und macht ihre Leistungen international sichtbar. Durch gezielten Austausch und strategische Kooperationen entsteht ein leistungsfähiges Ökosystem, das Innovationen und konkrete Ergebnisse in Wissenschaft und Anwendung fördert.
Zur Verstärkung unseres Teams in München suchen wir zum nächstmöglichen Zeitpunkt eine/n Project Manager Science Relations (m/w/d) Als Project Manager Science Relations (m/w/d) unterstützt du den Ausbau und die Pflege des wissenschaftlichen Netzwerks in der BAIOSPHERE. * BAIOSPHERE AGENCY/ Bayerische KI-Agentur * München * Befristeter Vertrag * Teilzeit, Vollzeit - Sei einer der ersten Bewerber - Schnelle Bewerbung - Vergütung nach TV-L (bis E 13) | befristet auf zwei Jahre | Voll- oder Teilzeit (mind. 80%) Die Bayerische KI-Agentur der Bayerischen Akademie der Wissenschaften vernetzt in der BAIOSPHERE führende Akteure und Projekte im Bereich Künstliche Intelligenz in Bayern und macht ihre Leistungen international sichtbar. Durch gezielten Austausch und strategische Kooperationen entsteht ein leistungsfähiges Ökosystem, das Innovationen und konkrete Ergebnisse in Wissenschaft und Anwendung fördert.
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Head of Medical Safety GCSP (m/f/d)
Head of Medical Safety GCSP (m/f/d)
Bavarian Nordic GmbH
Martinsried bei München, Bern
Teilweise Home-Office
As our Head of Medical Safety GCSP, you will be accountable for all medical safety related aspects of clinical safety and pharmacovigilance as well as ad hoc safety issues and innovation projects in your area of expertise. We are looking for an experienced Head of Medical Safety GCSP providing medical leadership across Global Clinical Safety & Pharmacovigilance (GCSP). * 10+ years of experience in clinical safety and pharmacovigilance, including senior medical safety role - Lead and develop the Medical Safety Team in Martinsried, Germany, or Bern, Switzerland! In this role, you will manage and mentor a team of six (Sr) Safety Physicians and (Sr) Safety Scientists. * Lead and develop the medical safety team and ensure that appropriate tools and skill sets are available/developed * Ensure high-quality clinical safety contributions to development programs and for the life-cycle ...
As our Head of Medical Safety GCSP, you will be accountable for all medical safety related aspects of clinical safety and pharmacovigilance as well as ad hoc safety issues and innovation projects in your area of expertise. We are looking for an experienced Head of Medical Safety GCSP providing medical leadership across Global Clinical Safety & Pharmacovigilance (GCSP). * 10+ years of experience in clinical safety and pharmacovigilance, including senior medical safety role - Lead and develop the Medical Safety Team in Martinsried, Germany, or Bern, Switzerland! In this role, you will manage and mentor a team of six (Sr) Safety Physicians and (Sr) Safety Scientists. * Lead and develop the medical safety team and ensure that appropriate tools and skill sets are available/developed * Ensure high-quality clinical safety contributions to development programs and for the life-cycle ...
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Schnelle Bewerbung
Als Teamlead (m/w/d) Regulatory Affairs EU/Germany übernimmst du die fachliche und disziplinarische Führung eines engagierten Teams, das sich auf den deutschen und europäischen Markt konzentriert, und steuerst komplexe Zulassungsprozesse mit höchster Verlässlichkeit. * Führungsverantwortung: Führe, inspiriere und entwickle dein Team – von Werkstudierenden bis hin zu erfahrenen Regulatory Affairs Managern – auf Basis unserer Core Values, damit jedes Teammitglied weiß, was wann zu tun ist, und gemeinsam mit dir Höchstleistung erzielt. * Regulatory-Erfahrung: Du hast bereits fundierte Erfahrung im Bereich Regulatory Affairs gesammelt – mit nachweisbarem Schwerpunkt auf dem deutschen Markt und der Zusammenarbeit mit deutschen Zulassungsbehörden wie dem BfArM; Kenntnisse im europäischen Zulassungsumfeld sind dabei ebenso Voraussetzung.
Als Teamlead (m/w/d) Regulatory Affairs EU/Germany übernimmst du die fachliche und disziplinarische Führung eines engagierten Teams, das sich auf den deutschen und europäischen Markt konzentriert, und steuerst komplexe Zulassungsprozesse mit höchster Verlässlichkeit. * Führungsverantwortung: Führe, inspiriere und entwickle dein Team – von Werkstudierenden bis hin zu erfahrenen Regulatory Affairs Managern – auf Basis unserer Core Values, damit jedes Teammitglied weiß, was wann zu tun ist, und gemeinsam mit dir Höchstleistung erzielt. * Regulatory-Erfahrung: Du hast bereits fundierte Erfahrung im Bereich Regulatory Affairs gesammelt – mit nachweisbarem Schwerpunkt auf dem deutschen Markt und der Zusammenarbeit mit deutschen Zulassungsbehörden wie dem BfArM; Kenntnisse im europäischen Zulassungsumfeld sind dabei ebenso Voraussetzung.
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Schnelle Bewerbung
Als Junior Project Manager steigst Du in eine der deutschen TOP-Beratungen für die Pharma-Marktforschung ein. Hierfür suchen wir Dich als gleichermaßen analytisch denkenden als auch betriebswirtschaftlich beratenden Junior Project Manager. * pharmafakt GmbH pharmafakt ist eine Pharma-Unternehmensberatung in München. Seit 1998 unterstützt pharmafakt die pharmazeutische Industrie, Verbände und Forschung mit umfangreichen, differenzierten und grundsätzlich datengestützten Studien und Analysen sowie ausgewiesener Consulting-Expertise bei allen Fragestellungen im Bereich des Arzneimittelmarktes. Du verantwortest die Projektabstimmung (mit Beratern, der Pharmaindustrie und unseren Partnern), Projektkonzeption, Projektkoordination der von den pharmafakt-Beratern akquirierten Projekte. * München * Feste Anstellung * Homeoffice möglich, Vollzeit - Schnelle Bewerbung
Als Junior Project Manager steigst Du in eine der deutschen TOP-Beratungen für die Pharma-Marktforschung ein. Hierfür suchen wir Dich als gleichermaßen analytisch denkenden als auch betriebswirtschaftlich beratenden Junior Project Manager. * pharmafakt GmbH pharmafakt ist eine Pharma-Unternehmensberatung in München. Seit 1998 unterstützt pharmafakt die pharmazeutische Industrie, Verbände und Forschung mit umfangreichen, differenzierten und grundsätzlich datengestützten Studien und Analysen sowie ausgewiesener Consulting-Expertise bei allen Fragestellungen im Bereich des Arzneimittelmarktes. Du verantwortest die Projektabstimmung (mit Beratern, der Pharmaindustrie und unseren Partnern), Projektkonzeption, Projektkoordination der von den pharmafakt-Beratern akquirierten Projekte. * München * Feste Anstellung * Homeoffice möglich, Vollzeit - Schnelle Bewerbung
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Wir suchen einen Molecular Business Development Manager (m/w/d) Mit Deinen Kolleginnen und Kollegen im Gebiet – den Account Managern und Clinical Education Managern - arbeitest Du konstruktiv und vertrauensvoll zusammen. * BIOMERIEUX * Süddeutschland * Feste Anstellung * Vollzeit - Als ein weltweit führendes Unternehmen im Bereich der In-vitro-Diagnostik stellt bioMérieux seit über 60 Jahren diagnostische Lösungen zum Nachweis von Infektionskrankheiten und Kontaminationen bereit– für eine bessere Patientenversorgung und mehr Verbrauchersicherheit. Willst Du dazu beitragen, weltweit Leben zu retten? Werde Teil der über 14.000 Mitarbeiterinnen und Mitarbeiter von bioMérieux! Deine Aufgaben - Gebiet: Süddeutschland (Freiburg, Tübingen, Karlsruhe, Heidelberg, Mannheim, Saarbrücken und Aschaffenburg). In Deinem Außendienstgebiet bist Du die zentrale Ansprechperson für unsere Kunden, wenn es um anspruchsvolle ...
Wir suchen einen Molecular Business Development Manager (m/w/d) Mit Deinen Kolleginnen und Kollegen im Gebiet – den Account Managern und Clinical Education Managern - arbeitest Du konstruktiv und vertrauensvoll zusammen. * BIOMERIEUX * Süddeutschland * Feste Anstellung * Vollzeit - Als ein weltweit führendes Unternehmen im Bereich der In-vitro-Diagnostik stellt bioMérieux seit über 60 Jahren diagnostische Lösungen zum Nachweis von Infektionskrankheiten und Kontaminationen bereit– für eine bessere Patientenversorgung und mehr Verbrauchersicherheit. Willst Du dazu beitragen, weltweit Leben zu retten? Werde Teil der über 14.000 Mitarbeiterinnen und Mitarbeiter von bioMérieux! Deine Aufgaben - Gebiet: Süddeutschland (Freiburg, Tübingen, Karlsruhe, Heidelberg, Mannheim, Saarbrücken und Aschaffenburg). In Deinem Außendienstgebiet bist Du die zentrale Ansprechperson für unsere Kunden, wenn es um anspruchsvolle ...
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Clinician for the Clinical Centre of Excellence (f/m/d)
Clinician for the Clinical Centre of Excellence (f/m/d)
TÜV SÜD
München, Ahmedabad, Madrid, Lissabon, Warschau
Teilweise Home-Office
TÜV SÜD * München, Ahmedabad, Madrid, Lissabon, Warschau * Feste Anstellung * Homeoffice möglich, Teilzeit, Vollzeit - Introduction - At TÜV SÜD we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD. If you want to shape the future with us, we look forward to receiving your application at our locations in Munich, Delhi, Ahmedabad, Madrid, Lisbon, or Warsaw. Tasks * Assessing clinical evaluations as part of technical documentation assessments according to the requirements layed down in the European Medical Device Regulation (MDR)
TÜV SÜD * München, Ahmedabad, Madrid, Lissabon, Warschau * Feste Anstellung * Homeoffice möglich, Teilzeit, Vollzeit - Introduction - At TÜV SÜD we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TÜV SÜD. If you want to shape the future with us, we look forward to receiving your application at our locations in Munich, Delhi, Ahmedabad, Madrid, Lisbon, or Warsaw. Tasks * Assessing clinical evaluations as part of technical documentation assessments according to the requirements layed down in the European Medical Device Regulation (MDR)
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Senior Quality Manager CMO (m/f/x) Antibody Drug Conjugate (ADC) Manufacturing
Senior Quality Manager CMO (m/f/x) Antibody Drug Conjugate (ADC) Manufacturing
Daiichi Sankyo Europe GmbH
München
As Senior Quality Manager CMO, you will serve as the primary contact for all quality-related matters at Contract Manufacturing Organizations (CMOs). o Define together with the CMO effective CAPAs and track the timely implementation - o The QA CMO is the person responsible for preparing and negotiating QAAs with CMOs and ensures the CMOs work in accordance with DS QAAs - o Share knowledge and expertise within QA or to other functions to improvement CMO management at DS - o You are involved in establishment of new manufacturing processes and site transfer activities and act as quality supporting PPQ and validation activities - You will be responsible for managing quality oversight at CMOs, ensuring the implementation and maintenance of Daiichi Sankyo's quality standards (GMP/GDP) and regulatory requirements for our oncology products.
As Senior Quality Manager CMO, you will serve as the primary contact for all quality-related matters at Contract Manufacturing Organizations (CMOs). o Define together with the CMO effective CAPAs and track the timely implementation - o The QA CMO is the person responsible for preparing and negotiating QAAs with CMOs and ensures the CMOs work in accordance with DS QAAs - o Share knowledge and expertise within QA or to other functions to improvement CMO management at DS - o You are involved in establishment of new manufacturing processes and site transfer activities and act as quality supporting PPQ and validation activities - You will be responsible for managing quality oversight at CMOs, ensuring the implementation and maintenance of Daiichi Sankyo's quality standards (GMP/GDP) and regulatory requirements for our oncology products.
Regulatory Affairs Our Regulatory Affairs Department ensures that products comply with applicable regulations and standards. This includes providing strategic input for product development, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes affecting existing products and future product developments. * Establish a process for regulatory intelligence monitoring for RF and environmental related regulatory changes relevant to the company * Interpret and institute necessary change projects within regulatory and cross-department to ensure continued compliance on assigned topics * Knowledge of global RF regulatory requirements certification procedures including submission and testing needs, as well as basic technical understanding of radio equipment, radio testing or electronics design is desired
Regulatory Affairs Our Regulatory Affairs Department ensures that products comply with applicable regulations and standards. This includes providing strategic input for product development, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes affecting existing products and future product developments. * Establish a process for regulatory intelligence monitoring for RF and environmental related regulatory changes relevant to the company * Interpret and institute necessary change projects within regulatory and cross-department to ensure continued compliance on assigned topics * Knowledge of global RF regulatory requirements certification procedures including submission and testing needs, as well as basic technical understanding of radio equipment, radio testing or electronics design is desired
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Wir suchen zum nächstmöglichen Termin in München einen Market Research Manager (m/w/d) * Bereitstellung relevanter Informationen und enge crossfunktionale Zusammenarbeit mit den Fachbereichen Marketing, Medical, Patient-In, Market Access und Vertrieb zur Erarbeitung relevanter Entscheidungshilfen für die strategische Produktausrichtung * Servier Deutschland GmbH * München * Feste Anstellung * Homeoffice möglich, Vollzeit - Sei einer der ersten Bewerber - Servier ist ein global agierendes wie auch forschendes Pharmaunternehmen mit Hauptsitz in Frankreich und deutscher Niederlassung in München, das als private Stiftung geführt wird. Wir versorgen täglich weltweit Menschen mit unseren Medikamenten in den Bereichen Hämatologie / Onkologie und Herz-Kreislauf. Mit hohen Investitionen in Forschung und Entwicklung treiben wir den therapeutischen Fortschritt voran.
Wir suchen zum nächstmöglichen Termin in München einen Market Research Manager (m/w/d) * Bereitstellung relevanter Informationen und enge crossfunktionale Zusammenarbeit mit den Fachbereichen Marketing, Medical, Patient-In, Market Access und Vertrieb zur Erarbeitung relevanter Entscheidungshilfen für die strategische Produktausrichtung * Servier Deutschland GmbH * München * Feste Anstellung * Homeoffice möglich, Vollzeit - Sei einer der ersten Bewerber - Servier ist ein global agierendes wie auch forschendes Pharmaunternehmen mit Hauptsitz in Frankreich und deutscher Niederlassung in München, das als private Stiftung geführt wird. Wir versorgen täglich weltweit Menschen mit unseren Medikamenten in den Bereichen Hämatologie / Onkologie und Herz-Kreislauf. Mit hohen Investitionen in Forschung und Entwicklung treiben wir den therapeutischen Fortschritt voran.
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