Head of Clinical Affairs
Vor 7 Tagen
**magnetic blood purification****:
**Unser Kunde**
hemotune AG ist ein Schweizer Medizintechnik-Start-up-Unternehmen, das aus der ETH Zürich hervorgegangen ist. Das Ziel ist die Entwicklung eines lebensrettenden, bahnbrechenden Medizinprodukts für die gezielte Blutreinigung.
Das Unternehmen mit Standort in Zürich befindet sich zurzeit in der präklinischen Entwicklungsphase. Zur Unterstützung des Teams suchen wir eine/n:
**Head of Clinical Affairs (w/m/d) 80-100%****:
**Ihr Verantwortungsbereich**
- Verantwortlich für alle klinischen Prüfungen sowie deren Vorbereitung, Planung, Umsetzung und Einreichung nach den Regularien (ISO 14155, ICH-GCP)
- Verfassen von Dokumenten für klinische Prüfungen (z. B. CIP, CRF, Einverständniserklärung, Patienteninformationen) gemäss ISO 14155, ICH-GCP und geltenden Normen
- Wöchentliche Berichterstattung an den CEO
- Durchführen von internen und externen Audits
- Mitwirkung bei der strategischen Geschäftsentwicklung
- Unterstützung bei der Überprüfung von Publikationsentwürfen
- Verantwortung für die Budget
- und Zeitplanung für die gesamte klinische Strategie
- Mitarbeit im Projektteams für die Weiterentwicklungen der Produktdefinition bis zum Markt Launch
- Vorbereitung von wissenschaftlichen Veröffentlichungen der klinischen Daten
- Durchführung von klinischen Bewertungen
- Verantwortlich für die externe Kommunikation mit den Stakeholdern
**Ihr Profil**
- Erfolgreich abgeschlossenes naturwissenschaftliches Studium in einem klinischen Bereich oder vergleichbar
- Langjährige Erfahrung im klinischen Projektmanagement in der klinischen Forschungsabteilung von Medizinprodukten/Pharmaunternehmen/CRO
- Profunde Berufserfahrung im Bereich klinische Bewertung von Medizinprodukten (Klasse II - III)
- Umfangreiche Kenntnisse den einschlägigen europäischen und internationalen Regularien (GPC / ISO 14155)
- Sehr gute Englisch
- und Deutschkenntnisse in Wort und Schrift
- Analytische Fähigkeiten und Kreativität sowie Kommunikationsstärke und Organisationstalent in einem internationalen Umfeld
**Ihre Vorteile**
- Mitwirkung in der Markteinführung
- Dynamisches Arbeitsumfeld in einem hoch motivierten Start-up-Team, mit flachen Hierarchien und viel Raum für Selbstverwirklichung und Umsetzung Ihrer Ideen
- Einen spannenden und modernen Arbeitsplatz im Bio-Technopark Schlieren
- Flexible Arbeitszeiten und mobiles Arbeiten
-
Internship in Clinical Affairs
Vor 4 Tagen
Zurich, Schweiz Lumendo AG VollzeitLumendo is a Medtech startup and a spin-off from ETH Zürich and EPFL Lausanne. We develop technologies to improve the efficiency and success rate of dental root canal treatments. Our goal is to improve the treatment by a disruptive cleaning technology and a novel, light-activated root canal filling material, thus helping people to keep their natural teeth...
-
Clinical Affairs Manager
Vor 3 Tagen
Zurich, Schweiz Sonova VollzeitWho we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...
-
Clinical Affairs Manager
Vor 3 Tagen
Zurich, Schweiz Sonova AG VollzeitWho we are In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we - through our core business brands Phonak, Unitron, Sennheiser, Advanced...
-
Internship in Clinical Affairs
vor 17 Stunden
Zurich, Schweiz Lumendo AG VollzeitLumendo is a Medtech startup and a spin-off from ETH Zürich and EPFL Lausanne. We develop technologies to improve the efficiency and success rate of dental root canal treatments. Our goal is to improve the treatment by a disruptive cleaning technology and a novel, light-activated root canal filling material, thus helping people to keep their natural teeth...
-
Zurich, Schweiz Lumendo AG VollzeitLumendo is a Medtech startup and a spin-off from ETH Zürich and EPFL Lausanne. We develop technologies to improve the efficiency and success rate of dental root canal treatments. Our goal is to improve the treatment by a disruptive cleaning technology and a novel, light-activated root canal filling material, thus helping people to keep their natural teeth...
-
Head of Integrity and Regulatory Affairs
Vor 2 Tagen
Zurich, Schweiz ABB Vollzeit**Head of Integrity and Regulatory affairs**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations....
-
Zurich, Schweiz MSD VollzeitThe Global Director of Medical Affairs (GDMA) for Melanoma coordinates the development of the Global Scientific and Medical Affairs Plans for their assigned asset(s). The GDMA contributes substantially to and is a valued co-strategist on the Global Franchise Team and assigned Product Development (Sub-) Teams. The GDMA contributes to Life Cycle Management...
-
Werkstudent Clinical
Vor 5 Tagen
Zurich, Schweiz BIOTRONIK VollzeitWerkstudent Clinical (40%) As one of the world´s leading manufacturers of cardio - and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of...
-
Clinical Project Manager
Vor 2 Tagen
Zurich, Schweiz BIOTRONIK VollzeitClinical Project Manager BIOTRONIK is one of the leading manufacturers of cardio - and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology...
-
Medical Science Liaison
vor 1 Woche
Zurich, Schweiz Syneos Health Clinical Vollzeit**Overview** **Base location: Switzerland** The Regional Medical Science Liaison (MSL) serves as the primary field-based point of contact with healthcare providers (HCPs) including clinical investigators on a range of clinical and scientific issues. The primary role is to deliver and facilitate medical education and communications, research, and scientific...
-
Head Governmental Affairs Switzerland
vor 17 Stunden
Zurich, Schweiz UBS VollzeitSwitzerland - Zürich - Digital, Management Group, Research, Strategy - Group Functions **Job Reference #** - 276628BR **City** - Zürich **Job Type** - Full Time **Your role** - Are you a confident relationship builder and trusted advisor to senior decision makers? Do you have extensive experience in analyzing regulatory developments and providing...
-
Hema Divisional Head Urology Emea
Vor 3 Tagen
Zurich, Schweiz Boston Scientific Corporation Vollzeit**HEMA Divisional Head Urology EMEA**: - Remote Eligible: Hybrid- Onsite Location(s): Zürich, CH**Additional Locations**: France-Voisins le Bretonneux; Germany-Düsseldorf; Italy-Milan; Spain-Madrid; United Kingdom-Hemel Hempstead **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll...
-
Professor and Chair of Internal Medicine
Vor 3 Tagen
Zurich, Schweiz Department of Internal Medicine VollzeitDepartment of Internal Medicine_ **Professor and Chair of Internal Medicine** Professor and Chair of Internal Medicine The Professor and Chair of Internal Medicine will be responsible for research, teaching, and clinical services in this discipline. He or she will be appointed as head of Internal Medicine at the University Hospital Zurich. With the start of...
-
Director, Clinical Monitoring
vor 1 Woche
Zurich, Schweiz Proclinical VollzeitProclinical Staffing are exclusively representing a US Biopharma who are based in the German speaking part of Switzerland who are looking Director of Clinical Monitoring to join their team on a permanent basis. This is a newly created role within their EU team which has opened due to the expansion of their Phase II & III studies into Europe so this role will...
-
Global Regulatory Affairs Labelling Manager
Vor 3 Tagen
Zurich, Schweiz CSL Behring VollzeitCSL Vifor is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent global position in the Global Regulatory Affairs Labelling team has arisen. Which can be based at any of our CSL R&D Hubs (Maidenhead UK, Amsterdam, NL, Bern, CH, Zurich, CH, KOP, PA or Waltham,...
-
Head of Quality
Vor 5 Tagen
Zurich, Schweiz Bruker VollzeitÃberblick: Aufgaben/Verantwortlichkeiten: - Leading and developing a team of around 20 professionals in 3 countries for Quality Assurance, Regulatory Affairs and Environment, Health & Safety. Sites close to Zurich CH (main location for this role), Karlsruhe GER and Strasbourg FR (regular travel required; 2 days out of 5 home office option) - EU IVDR roll...
-
Junior Regulatory Affairs Manager
Vor 2 Tagen
Zurich, Schweiz Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Head of Legal
vor 17 Stunden
Zurich, Schweiz Humentum AG VollzeitFor our customer, a global acting supplier of high-performance industrial components and engineered solutions, who is expanding its business areas both horizontally and vertically and its business volume is increasing worldwide, we seek you as: **Head of Legal & Compliance** Job-ID 67281 As the Head of Legal and Compliance you will be part of the Group...
-
Medical Affairs Scientist
Vor 6 Tagen
Zurich, Schweiz Pfizer VollzeitMedical Affairs Scientist (M/F/d) 80-100% The Medical Affairs Scientist (MAS) is the medical scientific companies’ Point of Contact for HCPs, medical societies, regulators, academia, and other external scientific stakeholders. The MAS is responsible for maintaining the highest scientific standards, independence, and compliance in every...
-
Clinical Bioanalysis Project Manager
Vor 5 Tagen
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. For our Vaccine Business Unit in Zurich, we are looking for a **Clinical Bioanalysis Project Manager...