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47 Treffer für Clinical Affairs Jobs in Planegg im Umkreis von 30 km
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• Collaborate closely with clinical development, regulatory affairs, CMC, nonclinical, safety, biomarker, and business development colleagues. HMNC Brain Health (HMNC) is a clinical-stage neuroscience company pioneering new therapies for mental health disorders. We are seeking a senior Clinical Pharmacology expert who can combine deep pharmaceutical industry experience with a strong understanding of regulatory authority expectations. The successful candidate should not only understand clinical pharmacology, DMPK, PopPK, PBPK, PK/PD, ADME, and safety data, but also be able to interpret these data critically and translate them into clear development decisions. The role requires someone who has worked in or closely with the pharmaceutical industry and understands how development decisions are made under real-world constraints of time, budget, regulatory risk, and clinical feasibility.
• Collaborate closely with clinical development, regulatory affairs, CMC, nonclinical, safety, biomarker, and business development colleagues. HMNC Brain Health (HMNC) is a clinical-stage neuroscience company pioneering new therapies for mental health disorders. We are seeking a senior Clinical Pharmacology expert who can combine deep pharmaceutical industry experience with a strong understanding of regulatory authority expectations. The successful candidate should not only understand clinical pharmacology, DMPK, PopPK, PBPK, PK/PD, ADME, and safety data, but also be able to interpret these data critically and translate them into clear development decisions. The role requires someone who has worked in or closely with the pharmaceutical industry and understands how development decisions are made under real-world constraints of time, budget, regulatory risk, and clinical feasibility.
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Collect product performance and user feedback for Research & Development (R&D), Medical & Clinical Affairs (MACA), and commercial teams to inform life cycle management, next-generation innovations, clinical study designs, and commercial strategies. Key position within our Medical Affairs function, primarily supporting Convatec's nitric oxide next-generation adaptive platform (CNAP) business. Develop relationships with HCPs and clinical sites to support effective product evaluations, case studies, and long-term adoption. * Act as trusted scientific expert, delivering accurate and compliant medical science and clinical education to external stakeholders. * Partner with MSL and Medical Affairs colleagues to develop and disseminate new evidence. * Deliver tailored educational programs to HCPs, ensuring dissemination of our latest scientific and clinical evidence.
Collect product performance and user feedback for Research & Development (R&D), Medical & Clinical Affairs (MACA), and commercial teams to inform life cycle management, next-generation innovations, clinical study designs, and commercial strategies. Key position within our Medical Affairs function, primarily supporting Convatec's nitric oxide next-generation adaptive platform (CNAP) business. Develop relationships with HCPs and clinical sites to support effective product evaluations, case studies, and long-term adoption. * Act as trusted scientific expert, delivering accurate and compliant medical science and clinical education to external stakeholders. * Partner with MSL and Medical Affairs colleagues to develop and disseminate new evidence. * Deliver tailored educational programs to HCPs, ensuring dissemination of our latest scientific and clinical evidence.
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Domain-naher QA-Experte - Life Sciences (m/w/d)
Domain-naher QA-Experte - Life Sciences (m/w/d)
SPIRIT-TESTING Software & Services GmbH
München
Teilweise Home-Office
In dieser Rolle bringen Sie tiefes Domänenwissen aus den Life Sciences (z. B. klinische Studien, Regulatory Affairs, MedTech-Produktentwicklung oder Laborprozesse) mit einem klaren Fokus auf Software- und Systemqualität zusammen. * Clinical Operations * Regulatory Affairs
In dieser Rolle bringen Sie tiefes Domänenwissen aus den Life Sciences (z. B. klinische Studien, Regulatory Affairs, MedTech-Produktentwicklung oder Laborprozesse) mit einem klaren Fokus auf Software- und Systemqualität zusammen. * Clinical Operations * Regulatory Affairs
Noch nichts dabei? Es gibt 44 weitere Jobs, die zu deiner Suche passen könnten
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Senior Scientist Drug Product Process Development (gn) 2-Year Fixed-Term Contract
Senior Scientist Drug Product Process Development (gn) 2-Year Fixed-Term Contract
Formycon AG
Planegg
Teilweise Home-Office
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process. * Prepare high-quality scientific and technical documentation, such as reports, risk assessments, and development packages for internal and external (e.g., Quality, Regulatory Affairs, CDMOs)
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process. * Prepare high-quality scientific and technical documentation, such as reports, risk assessments, and development packages for internal and external (e.g., Quality, Regulatory Affairs, CDMOs)
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Schnelle Bewerbung
Director of Medical Affairs provides scientific and medical leadership to establish a deep understanding of the medical landscape regarding relevant, rare amyloidoses, such as AL-A, and Alexion products. Director of Medical Affairs Amyloidosis makes strategic contributions to Alexion's activities in the field of rare amyloidoses. They support all functions of the German subsidiary working in this field in achieving local targets and Alexion Global Medical Affairs in its mission to achieve treatment outcomes by establishing and continuously improving an evidence-based standard of medical care. * 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.
Director of Medical Affairs provides scientific and medical leadership to establish a deep understanding of the medical landscape regarding relevant, rare amyloidoses, such as AL-A, and Alexion products. Director of Medical Affairs Amyloidosis makes strategic contributions to Alexion's activities in the field of rare amyloidoses. They support all functions of the German subsidiary working in this field in achieving local targets and Alexion Global Medical Affairs in its mission to achieve treatment outcomes by establishing and continuously improving an evidence-based standard of medical care. * 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.
Schnelle Bewerbung
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. * Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies. * Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
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. * Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies. * Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
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 * Contribute to designing patient-centric processes and establishing best practice of patient engagement across the therapeutic lifecycle in Germany in strong alignment within the Corporate Affairs team (communications, governmental affairs and policy) * Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * Conceptualize and coordinate engagement of PAOs in data generation initiatives (HEOR/ MR) as well as in relation to local HTA processes or other post-marketing and policy initiatives, in close partnership with Medical Affairs and Market Access teams
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 * Contribute to designing patient-centric processes and establishing best practice of patient engagement across the therapeutic lifecycle in Germany in strong alignment within the Corporate Affairs team (communications, governmental affairs and policy) * Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * Conceptualize and coordinate engagement of PAOs in data generation initiatives (HEOR/ MR) as well as in relation to local HTA processes or other post-marketing and policy initiatives, in close partnership with Medical Affairs and Market Access teams
Schnelle Bewerbung
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 * Contribute to designing patient-centric processes and establishing best practice of patient engagement across the therapeutic lifecycle in Germany in strong alignment within the Corporate Affairs team (communications, governmental affairs and policy) * Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * Conceptualize and coordinate engagement of PAOs in data generation initiatives (HEOR/ MR) as well as in relation to local HTA processes or other post-marketing and policy initiatives, in close partnership with Medical Affairs and Market Access teams
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 * Contribute to designing patient-centric processes and establishing best practice of patient engagement across the therapeutic lifecycle in Germany in strong alignment within the Corporate Affairs team (communications, governmental affairs and policy) * Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany * Conceptualize and coordinate engagement of PAOs in data generation initiatives (HEOR/ MR) as well as in relation to local HTA processes or other post-marketing and policy initiatives, in close partnership with Medical Affairs and Market Access teams
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ProSiebenSat.1 Careers * München * Praktikum * Homeoffice möglich, Vollzeit - Anschreiben nicht erforderlich - Let's #CreateMomentsThatMatter together! Wir sind das Zuhause von populärer Unterhaltung und verlässlichem Infotainment und einer der führenden Entertainment-Anbieter im deutschsprachigen Raum. Unser Kerngeschäft Entertainment ergänzen wir durch digitale Verbrauchermarken in dem Segment Commerce & Dating. Hinter ProSiebenSat.1 stehen über 6.000 Mitarbeiter:innen, die unsere Zuschauer:innen und Kund:innen jeden Tag aufs Neue und mit großer Leidenschaft begeistern! Hier starten Erfolgsstories. Auch deine? Das erwartet dich - In der Konzernrechtsabteilung beraten, betreuen, verwalten und verhandeln wir Auftrags- und Produktionsverträge, IT- und Datenschutzverträge, Forderungsanmeldungen in insolvenzrechtlichen Verfahren, gesellschaftsrechtliche Vorgänge, Lizenzverträge mit ...
ProSiebenSat.1 Careers * München * Praktikum * Homeoffice möglich, Vollzeit - Anschreiben nicht erforderlich - Let's #CreateMomentsThatMatter together! Wir sind das Zuhause von populärer Unterhaltung und verlässlichem Infotainment und einer der führenden Entertainment-Anbieter im deutschsprachigen Raum. Unser Kerngeschäft Entertainment ergänzen wir durch digitale Verbrauchermarken in dem Segment Commerce & Dating. Hinter ProSiebenSat.1 stehen über 6.000 Mitarbeiter:innen, die unsere Zuschauer:innen und Kund:innen jeden Tag aufs Neue und mit großer Leidenschaft begeistern! Hier starten Erfolgsstories. Auch deine? Das erwartet dich - In der Konzernrechtsabteilung beraten, betreuen, verwalten und verhandeln wir Auftrags- und Produktionsverträge, IT- und Datenschutzverträge, Forderungsanmeldungen in insolvenzrechtlichen Verfahren, gesellschaftsrechtliche Vorgänge, Lizenzverträge mit ...
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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
Assessing clinical evaluations as part of technical documentation assessments according to the requirements layed down in the European Medical Device Regulation (MDR) * Serving as an internal point of contact for clinical matters as part of the interfaces with other departments, offering support and close exchange with colleagues * Optionally providing support during audits of clinical processes of as a clinial expert (remote or on-site) * Four years of clinical practice in health care services or related sectors in the area of Cardiac surgery * Two years of experience in usage, development or testing/evaluation of medical devices or clinical studies/investigations or clinical evaluation of medical devices * Experience with MDR, regulatory aspects of medical devices, clinical evaluation for medical devices / medical writing is a plus.
Assessing clinical evaluations as part of technical documentation assessments according to the requirements layed down in the European Medical Device Regulation (MDR) * Serving as an internal point of contact for clinical matters as part of the interfaces with other departments, offering support and close exchange with colleagues * Optionally providing support during audits of clinical processes of as a clinial expert (remote or on-site) * Four years of clinical practice in health care services or related sectors in the area of Cardiac surgery * Two years of experience in usage, development or testing/evaluation of medical devices or clinical studies/investigations or clinical evaluation of medical devices * Experience with MDR, regulatory aspects of medical devices, clinical evaluation for medical devices / medical writing is a plus.
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Schnelle Bewerbung
BAUER KOMPRESSOREN GmbH * München * Feste Anstellung * Homeoffice möglich, Vollzeit - Schnelle Bewerbung - BAUER KOMPRESSOREN ist ein führendes Unternehmen in der Hochdruck-Branche und bieten Ihnen die Möglichkeit, in einem spannenden Umfeld zu arbeiten, das sich weltweit erstreckt. Unsere Stärke! Innovative Produkte und das leidenschaftliche Engagement unserer Mitarbeiterinnen und Mitarbeiter die überall auf der Welt für Qualität stehen. Als Tochterunternehmen der BAUER GROUP, die mit über 1550 Mitarbeitenden in 22 Tochtergesellschaften einen Umsatz von 420 Mio. EUR erzielt, bieten wir Ihnen nicht nur einen Job, sondern eine Karriere mit Perspektive. Normen & Zertifizierung (Abt.: Forschung & Entwicklung) Lust auf spannende Herausforderungen in einem internationalen Unternehmen? Wir suchen eine engagierte Fachkraft (m/w/d), die Zulassungen, Zertifizierungen und ...
BAUER KOMPRESSOREN GmbH * München * Feste Anstellung * Homeoffice möglich, Vollzeit - Schnelle Bewerbung - BAUER KOMPRESSOREN ist ein führendes Unternehmen in der Hochdruck-Branche und bieten Ihnen die Möglichkeit, in einem spannenden Umfeld zu arbeiten, das sich weltweit erstreckt. Unsere Stärke! Innovative Produkte und das leidenschaftliche Engagement unserer Mitarbeiterinnen und Mitarbeiter die überall auf der Welt für Qualität stehen. Als Tochterunternehmen der BAUER GROUP, die mit über 1550 Mitarbeitenden in 22 Tochtergesellschaften einen Umsatz von 420 Mio. EUR erzielt, bieten wir Ihnen nicht nur einen Job, sondern eine Karriere mit Perspektive. Normen & Zertifizierung (Abt.: Forschung & Entwicklung) Lust auf spannende Herausforderungen in einem internationalen Unternehmen? Wir suchen eine engagierte Fachkraft (m/w/d), die Zulassungen, Zertifizierungen und ...
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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)
Für unseren Standort Feldkirchen bei München suchen wir zur Unterstützung der Abteilung Regulatory Affairs schnellstmöglich einen Specialist Regulatory Affairs für Medizinprodukte (m/w/d)
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Schnelle Bewerbung
Die Division Study Support and International Affairs der TUM School of Management mit den Teams Admissions, Grade Management und International Office unterstützt die Studierenden und Promovierenden der School während ihres gesamten Studienzyklus. * Zusammenarbeit mit dem Team International Affairs, dem Associate Dean for Internationalization, dem International Office sowie zentralen Universitätseinheiten
Die Division Study Support and International Affairs der TUM School of Management mit den Teams Admissions, Grade Management und International Office unterstützt die Studierenden und Promovierenden der School während ihres gesamten Studienzyklus. * Zusammenarbeit mit dem Team International Affairs, dem Associate Dean for Internationalization, dem International Office sowie zentralen Universitätseinheiten
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Associate Director (m/f/d), Computational Pathology Biomarker Lead (Oncology/BioPharma)
Associate Director (m/f/d), Computational Pathology Biomarker Lead (Oncology/BioPharma)
AstraZeneca
München
Do you thrive at the intersection of AI innovation and clinical translation? In this position you will work with a multi-disciplinary team to pioneer AI-enabled computational pathology and multi-modal biomarkers that fundamentally change how we approach patient selection and drug development, aiming to improve clinical outcomes. Within AI for Computational Pathology and Biomarkers, we're pioneering AI-powered solutions that transform patient selection, biomarker development, and clinical decision-making at enterprise scale. * Provide scientific leadership for AI-powered computational pathology and multimodal biomarker development across AstraZeneca's Oncology and/or BioPharmaceuticals portfolio, delivering biomarkers that support patient selection and translational decision-making from target validation through clinical development.
Do you thrive at the intersection of AI innovation and clinical translation? In this position you will work with a multi-disciplinary team to pioneer AI-enabled computational pathology and multi-modal biomarkers that fundamentally change how we approach patient selection and drug development, aiming to improve clinical outcomes. Within AI for Computational Pathology and Biomarkers, we're pioneering AI-powered solutions that transform patient selection, biomarker development, and clinical decision-making at enterprise scale. * Provide scientific leadership for AI-powered computational pathology and multimodal biomarker development across AstraZeneca's Oncology and/or BioPharmaceuticals portfolio, delivering biomarkers that support patient selection and translational decision-making from target validation through clinical development.
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
Director (gn) Business Development - Licensing & Alliance Management
Director (gn) Business Development - Licensing & Alliance Management
Formycon AG
Planegg
Teilweise Home-Office
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
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Schnelle Bewerbung
Schnittstellenmanagement: Eigenverantwortliche Steuerung von Projekten und enge Zusammenarbeit mit Bereichen wie Key Account Management, Einkauf, B2C-Marketing, Innendienst und Pharmaceutical Affairs.
Schnittstellenmanagement: Eigenverantwortliche Steuerung von Projekten und enge Zusammenarbeit mit Bereichen wie Key Account Management, Einkauf, B2C-Marketing, Innendienst und Pharmaceutical Affairs.
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Wir suchen ab sofort einen Strategic Project Manager - QA&RA / R&D, der mit fundierter wissenschaftlicher Expertise, strukturiertem Denken und überzeugendem Auftreten an der Schnittstelle von Research & Development sowie Quality Assurance & Regulatory Affairs unsere Schlüsselprojekte - von Produktentwicklung bis hin zu internen Digitalisierung - eigenverantwortlich vorantreibt. * Du bringst bereits praktische Erfahrung in den Bereichen Regulatory Affairs, Quality, R&D, Medical Affairs oder vergleichbaren strategischen Bereichen in der Healthcare-Branche oder einer vergleichbaren Industrie mit und verfügst idealerweise über erste Projektmanagement-Kenntnisse.
Wir suchen ab sofort einen Strategic Project Manager - QA&RA / R&D, der mit fundierter wissenschaftlicher Expertise, strukturiertem Denken und überzeugendem Auftreten an der Schnittstelle von Research & Development sowie Quality Assurance & Regulatory Affairs unsere Schlüsselprojekte - von Produktentwicklung bis hin zu internen Digitalisierung - eigenverantwortlich vorantreibt. * Du bringst bereits praktische Erfahrung in den Bereichen Regulatory Affairs, Quality, R&D, Medical Affairs oder vergleichbaren strategischen Bereichen in der Healthcare-Branche oder einer vergleichbaren Industrie mit und verfügst idealerweise über erste Projektmanagement-Kenntnisse.
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Mehrjährige Berufserfahrung im Lebensmittelrecht, Spezifikationsmanagement, Regulatory Affairs oder einem verwandten Bereich der Lebensmittelindustrie
Mehrjährige Berufserfahrung im Lebensmittelrecht, Spezifikationsmanagement, Regulatory Affairs oder einem verwandten Bereich der Lebensmittelindustrie
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Mitarbeiter Qualitätssicherung Dokumentation (m/w/d)
Mitarbeiter Qualitätssicherung Dokumentation (m/w/d)
CODAN pvb Critical Care GmbH
Forstinning bei München
Teilweise Home-Office
Schnelle Bewerbung
Berufserfahrung im Bereich Qualitätsmanagement in der Medizintechnik (ISO 13485) oder mehrjährige Erfahrung im Bereich Regulatory Affairs in ähnlich regulierten Märkten
Berufserfahrung im Bereich Qualitätsmanagement in der Medizintechnik (ISO 13485) oder mehrjährige Erfahrung im Bereich Regulatory Affairs in ähnlich regulierten Märkten
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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
We are looking for an experienced Head of Medical Safety GCSP providing medical leadership across Global Clinical Safety & Pharmacovigilance (GCSP). 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. * Ensure high-quality clinical safety contributions to development programs and for the life-cycle management of marketed products in compliance with regulations, guidelines, BN operating procedures (SOPs) To succeed in this role, you must have a medical doctorate (MD) and leadership experience in clinical safety and pharmacovigilance. * 10+ years of experience in clinical safety and pharmacovigilance, including senior medical safety role - You have solid knowledge of global clinical safety and pharmacovigilance ...
We are looking for an experienced Head of Medical Safety GCSP providing medical leadership across Global Clinical Safety & Pharmacovigilance (GCSP). 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. * Ensure high-quality clinical safety contributions to development programs and for the life-cycle management of marketed products in compliance with regulations, guidelines, BN operating procedures (SOPs) To succeed in this role, you must have a medical doctorate (MD) and leadership experience in clinical safety and pharmacovigilance. * 10+ years of experience in clinical safety and pharmacovigilance, including senior medical safety role - You have solid knowledge of global clinical safety and pharmacovigilance ...
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The Senior Clinical Trial Coordinator assists the clinical research team to ensure that the study is conducted in accordance with GCP, all relevant SOPs, the protocol and in respect of the budget and timelines. They will oversee and mentor junior Clinical and as needed. * Previous experience in clinical research (in CROs, Pharma or academy/hospital experience) * Good knowledge of Clinical Research and Regulatory/Ethical requirements
The Senior Clinical Trial Coordinator assists the clinical research team to ensure that the study is conducted in accordance with GCP, all relevant SOPs, the protocol and in respect of the budget and timelines. They will oversee and mentor junior Clinical and as needed. * Previous experience in clinical research (in CROs, Pharma or academy/hospital experience) * Good knowledge of Clinical Research and Regulatory/Ethical requirements
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Mit Produktmanagement, Vertrieb, IT, Regulatory Affairs sowie externen Partnern arbeiten Sie eng und vertrauensvoll zusammen.
Mit Produktmanagement, Vertrieb, IT, Regulatory Affairs sowie externen Partnern arbeiten Sie eng und vertrauensvoll zusammen.
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Schnelle Bewerbung
5+ Jahre Berufserfahrung in den Bereichen Regulatory Affairs, Compliance oder Risk Management
5+ Jahre Berufserfahrung in den Bereichen Regulatory Affairs, Compliance oder Risk Management
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. 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. * Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring 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. 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. * Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. * Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
Beliebte Jobs
- Arzt
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- Sport
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- Kommunikation
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- Arzt Ausbildung
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- English Speaking
- Ausbildung Bauzeichner
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