Regulatory affairs specialist Jobs in Baar
Zuletzt aktualisiert: vor 1 Tag Clinical Development Lead / IVD and Liver Cancer ROCGJP00029130.The Clinical Development Lead Oncology is responsible for planning and implementation of Clinical Development activities for novel medi...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag Director, Europe & Canada (EUCAN) Communications.Competitive salary and benefits.Here at AstraZeneca, you’ll be valued for your unique knowledge.
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Clinical Development Lead / IVD and Liver Cancer
Coopers iET AGZug, Canton of Zug, SwitzerlandHomeoffice
Quick Apply
Manager Medical Affairs (m / f / w) Diabetes Care Austria and Switzerland
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Clinical Development Lead Oncology
EurojobRotkreuz For our international medical partner, Roche Diagnostics Int Ltd.Rotkreuz, we are looking for a qualified and motivated.Clinical Development Lead Oncology.
The Clinical Development Lead Oncology is ...Mehr anzeigenZuletzt aktualisiert: vor 2 Tagen
- Gesponsert
Quality Assurance Expert Pharma
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Director, Europe & Canada (EUCAN) Communications
AstraZenecaBaar,SwitzerlandVollzeit
- Gesponsert
AI Specialist in healthcare supply domain
Entrydell SAZug, CH We are seeking a Junior AI Specialist to join our team at a leading European provider of medical equipment.In this role, you will collaborate across departments to integrate AI technologies like.LL...Mehr anzeigenZuletzt aktualisiert: vor 23 Tagen
- Gesponsert
Clinical Development Lead Oncology
ITech Consult AGZug, CH Clinical Development Lead Oncology (m / f / d) - IVD / liver Indication / Medical Device / ICH-GCP, IVDD / IVDR, MDR, FDA, NMPA / VACC / English.
For our customer Roche Diagnostics International AG based ...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
INTERNATIONAL REGULATORY AFFAIRS 60%
gloor & lang Pharma and Biotech RecruitingRegion Zürich-Zug Innovative Biologic submissions – early to late phase.Our client is an R&D driven biotech company based in in Zurich.Own Research and development activities as well as international clinical develo...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Regulatory Affairs Manager for Austria and Switzerland (Alpine region)
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Regulatory Professional - Zug, Switzerland or London
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Clinical Development Lead / IVD and Liver Cancer
Coopers iET AGZug, Canton of Zug, SwitzerlandVor einem Tag
Anstellungsart
- Homeoffice
- Quick Apply
StellenbeschreibungMedical degree or advanced degree in Life Sciences (PhD, PharmD or equivalent degree) with relevant expertise in the Healthcare Industry and / or academic institutions Min. 2-3 years of industry experience after PhD or coming straight from the industry with at least 5+ years of experience in IVD Strong experience in liver Indication (Fibrosis and / or Liver cancer) Min. 5+ years academic, diagnostics or pharma industry experience, preferably, having experience in IVD or Medical Device development in all stages of global studies, development of study protocol design, report writing and leading matrixed teams Ability to lead clinical development studies / programs and good knowledge in applicable standards and regulations (ICH-GCP, IVDD / IVDR, MDR, FDA, NMPA regulations etc.) especially in global studies in the US and negotiation with the FDA
Clinical Development Lead / IVD and Liver Cancer ROCGJP00029130
The Clinical Development Lead Oncology is responsible for planning and implementation of Clinical Development activities for novel medical value diagnostic solutions in the areas of Chronic Liver Diseases , with a primary focus on Liver fibrosis.
Duration : 12 months / possible extension
Location : Rotkreuz
Full time, Hybrid
Responsibilities :
- Serve as a subject matter expert for Liver Oncology, clinical study design and evidence generation strategies for internal and external stakeholders in the assigned indication area.
- Responsible for critical review of study results, protocol and report generation to support new product development.
- Works with colleagues from Business, Medical Affairs, Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, and other functions to ensure appropriate implementation of clinical development strategies.
- Builds and maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring operational excellence.
- Act as an ambassador and representative of Clinical Development establishing effective collaborative relationships with key functions for new and existing products, incl. clinical utility, intended use and claim extensions.
- Play a leadership role in maintaining clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation. Leads medical / scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies.
- Drives competitive differentiation, innovation and early pipeline activities and develops intellectual property strategy.
- Responsible for comprehensive literature reviews, supervises collation of relevant clinical and scientific information from different sources, and creates new scientific content (without guidance / direction).
- Demonstrate leadership skills; ability to mentor and provide an environment for personal and professional growth.
Must Haves :
Coopers iET AG ist eine agile Schweizer Recruiting Agentur , die Spezialisten und Führungskräfte in den Bereichen IT, Life Sciences, Engineering und Finance vermittelt. Mit flexiblen Ansätzen bringen wir Kandidat : innen und Unternehmen zusammen, die nicht nur fachlich, sondern auch menschlich zusammenpassen.