Gehaltsübersicht für Clinical in Schweiz

The perfect candidate is someone with solid experience in global study management (on a leading level), ideally with experience of early phases, someone with effective leadership skills still able and happy to do operational work. The CRSL is accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines Tasks & Responsibilities:Leads the cross-functional Study Management Team (SMT). In the SMT Leader (SMTL) role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting. The SMTL is accountable for the delivery of the clinical studies within the agreed timelines, budget and quality.Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking.Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders.Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site selection, initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines.For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle.Assures consistency and standards across a study or studies for all investigational sites and in line with project standards.  Must haves:Minimum 5 years in study management with extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studiesMinimum Bachelor (preference on Master) in Life Sciences Experience with global study managementExperience in pharma (preferred) or CRO Effective leadership skills, able to lead cross-functional teams across multiple time zonesExperience working in matrix environment and flat hierarchical team setting Nice to haves: Experience with early phases of clinical trialsNS & Infection & Oncology

Development and writing of study documentation including protocols, informed consent forms, clinical study reports, as well as clinical science input for study-specific operational and regulatory documentsBeing responsible for ongoing monitoring of clinical activities and study conduct, coordination of data collection, data cleaning and review, analysis, and interpretation as well as preparation and presentation of results for informed decision-makingParticipate in study management as clinical science representative to ensure trial deliverables are met according to timelines, budget, quality standards and operational procedures, within a global multidisciplinary cross-functional Study Management TeamProvide training and science input to operation colleagues and study site staff, as agreed with clinical operationsMonitor study progress on a regular basis to identify any problems or issues that could affect the results or completion of the study; you will investigate and employ problem-solving strategiesCollaborate with internal experts, leading academics, and external industry-based authorities and providers regarding experimental medicine and translational medicine studiesStay at the forefront of scientific and technical excellence by collaborating with the scientific community, contributing to presenting and publishing high-quality scientific abstracts, posters, articles and participating in key conferencesContribute to experimental medicine studies and/or projects in collaboration with internal or external Partners Your Profile:Doctoral degree in a relevant scientific field (e.g. Neuroscience, Pharmacology, Psychology // PhD, Pharma D or MD)Min 3 years in Clinical Science (experience in conducting on ongoing trials, collaboration with the operations team, vendor, site management)Industry experience (Pharma / Medical – not Medical Devices)Experience in drug development and clinical trials methodology and execution (Phase 0-2 preferable)Track-record of impactful scientific researchAbility to acquire knowledge in different disease indications and therapeutic areasAble to collaborate and thrive in a matrix environment and interact with a variety of individuals outside (e.g. investigators, partners, KOLs) and inside the company (e.g. regulatory affairs, biostatistics, clinical pharmacology, project management)Familiar with ICH-GCP regulation and regulatory guidance documents about clinical trialsStrong project-management skills and ability to prioritize tasks in a dynamic environmentStrong communication skills and ability to interact in a cross-functional matrix and represent science in study management teams, projects team and across the whole organization

Clinical tumor cytogenomic scientist as head of laboratory 100% Kinderspital Zürich as an employer Kinderspital Zürich is the largest university children's hospital in Switzerland with about 2,500 employees, and is one of the leading centres for paediatric and youth medicine in Europe. Although the hospital may be big, it's the little ones that count: up to 100,000 patients are cared for each year across 47 faculties, where we do everything in our power to ensure their well being. 'Kispi' not only offers cutting-edge devices and the highest quality of care, but also a good sense of interpersonal issues. Alongside its comprehensive range of paediatric medicine and surgery facilities, the children's hospital also offers a unique rehabilitation centre and a research centre. Your responsibilities Leading a team of scientists, lab technologists and a quality manager Responsibility for hiring and talent development in the laboratory Ensuring the overall delivery and quality of the Clinical Genomics Laboratory Responsibility for external quality assessments Analysis, controling and reporting of G-banded chromosomes, FISH, microarray (CytoScan HD and OncoScan), NGS and PCR-MRD (the last two can be learned on the job) Involvement in the ongoing development of our center for precision oncology for children Ensuring timely and successful launch of new clinical tests in collaboration with clinical teams Guiding the development of key operational metrics Engaging with the other leaders in the Center for Pediatric Laboratory Medicine (ZPL) in broader organizational strategic planning and cross-functional efforts Your profile Education as a scientist or physician with several years of experience in tumor cytogenomics Board certification as clinical cytogeneticist, i.e. FAMH, Fachhumangenetiker:in of the GfH Experience in leading a diagnostic genetic laboratory German language is advantageous but not mandatory Please apply even if you don't meet all of the requirements noted. It is rare that someone checks every single item. We encourage you to apply anyways. Prof. Dr. Martin Hersberger Head of the Center for Pediatric Laboratory Medicine (ZPL)+41 44 266 75 41 Kinderspital ZürichSteinwiesstrasse 758032 Zürich

Clinical cytogenomic scientist 100% Oncology laboratory Kinderspital Zürich as an employer Kinderspital Zürich is the largest university children's hospital in Switzerland with about 2,500 employees, and is one of the leading centres for paediatric and youth medicine in Europe. Although the hospital may be big, it's the little ones that count: up to 100,000 patients are cared for each year across 47 faculties, where we do everything in our power to ensure their well being. 'Kispi' not only offers cutting-edge devices and the highest quality of care, but also a good sense of interpersonal issues. Alongside its comprehensive range of paediatric medicine and surgery facilities, the children's hospital also offers a unique rehabilitation centre and a research centre. Your responsibilities Analysis, checking and report of G-banded chromosomes, FISH, miyroarray (CytoScan HD and OncoScan) Somatic NGS and PCR-MRD (can be learned on the job) Performance of external quality assessments Your profile Education as scientists or physicians with many years of experience in cytogenomics Experience in somatic NGS will be of advantage Board certification as clinical cytogeneticist, i.e. FAMH, FachhumangenetikerIn of the GfH, PCCC, ABMG Some knowledge of the German language is advantageous but not mandatory. However, a commitment to learn German should be made Equally patient and motivated to work in an international team PD Dr. Joëlle Tchinda Current Head of the Oncology LaboratoryPhone +41 44 266 70 41 Kinderspital ZürichSteinwiesstrasse 758032 Zürich

Clinical Project ManagerPosted 5 Monaten ago Clinical Project Manager Are you a passionate individual with a strong background in clinical project management? Are you dreaming of a job with a real impact on patients ’lives? Do you want to work for an innovative specialist spinal implant company and play a pivotal role in advancing medical research? If yes, come to join our clinical studies team! Together we can shape the future of the healthcare. As clinical project manager you will be responsible be for managing clinical studies on Spineart products from study set up to study closure, ensuring high quality and integrity of data, and compliance with relevant SOPs, regulatory requirements, timelines and within budget. Your main responsibilities will be: Developing and managing the clinical study plan, study budget, risk identification and mitigation. Coordinating the key study document developments, including the protocol and reports. Ensuring clear and aligned communication with stakeholders, between project team members and with the clinical site investigators and teams. Overseeing all study processes including site selection and management, monitoring and data management, safety management and vendor management. Leading study project teams, ensuring clear roles and responsbilities, issues and other risks are addressed swiflty and escalated as needed. Ensuring quality control of study documents and maintains study quality metrics. Training and overseeing monitors (CRAs) and quality of their work. Conducting and maintaining an up to date literature review by study. Contributing to continuous improvement initiatives, including WI writing. Contributing to PMCF plan, PMCF report and other regulatory clinical documents The Clinical Project Manager is expected to travel approximately 25% of the time. Your profile : Minimum 3 years of recent experience in clinical study management within medical device industry, class II & III medical devices preferred, spine surgery would be an advantage. Project management skills such as use of a formal process and system for planning and tracking ongoing progress of clinical projects. CRO and other Vendor management experience. Bachelor’s degree equivalent or higher qualification within Biological Science, Pharmacy, Medicine, Nursing, or another relevant life sciences discipline. Very good communication skills including the ability to to adjust communication style, to motivate the project team and investigational sites, and the ability to present complex information to both clinical and non-clinical disciplines. An individual who takes ‘ownership’ and who is also a team player Fluency in English (working language of the team) and advanced French written and oral. Who we are : Our success also depends on our team’s value. The human being is at the centre of our concerns. We pay special attention to our recruitment to make Spineart a great place to work. For us, soft skills are as important as hard skills. What we expect from our employees is nothing short of real team spirit, mutual assistance, and self-transcendence. Our philosophy: Quality, Innovation, Simplicity Our values: Respect, Integrity, Solution oriented

Job Description: We are recruiting a successful The Clinical Education Manager, Content is responsible for developing clinical education content according to Nobel Biocare’s portfolio and solutions. They create new and manage all existing educational content. They optimize content for distribution across multiple channels and clearly present complex clinical and training concepts. They work closely with internal and external stakeholders, including key experts, to continually assess the content is clinically relevant. They seek data to understand the performance of available content, adapt to maximize usage and manage the lifecycle of content. Overall, the Clinical Education Manager, Content creates best in class learning content to support Nobel Biocare’s current and future customers to develop their theoretical knowledge and practical skills driving their professional success. Develop, write and edit educational content e.g. presentations, how to videos, webinars, e-learning courses, clinical and scientific evidence, clinical cases, speaker resources, pre and post course reading materials. Adapt content formats to suit different channels and audiences on and offline and maximize usage. Manage access and regularly update content held on the speaker portal and other centralized resources. Ensure inclusion of key messaging and theoretical and practical learning concepts. Proactively identify and address gaps in both launch and lifecycle content. Support development of marketing, product and course content to drive consistency in educational messaging, clinical accuracy and reliable references. Ensure that all clinical education assets meet established internal and external (e.g. regulatory, best practice) standards by coordinating stakeholders reviews and approvals. Develop and implement content guidelines and templates to enable consistent standards across all educational assets. Develop learning journeys that dental professionals can tailor to their educational needs. Establish relationships with external vendors, agencies, publishers, editors and other stakeholders for the external publication of content. Identify and cultivate opportunities for strategic content partnerships. Effectively manage and motivate key experts to develop content collaboratively. Support local teams in consistent use of educational messages, standards and proper use of educational assets for local purposes. Manage demand and process for localisation of content to enable usage worldwide. Build competitive knowledge within the field of training and education to keep abreast of market trends and needs. Domestic and international travel to manage speakers and content on-site at events. Build effective working relationships with colleagues responsible for product management, marketing, graphics, international courses and LMS, science, clinical research, materials, key expert management, regulatory affairs, sales training. #LI-MK1 #IND456 Job Requirements: Critical Knowledge and Qualifications: University degree in a medical field. Understanding of scientific and clinical evidence. Knowledge of industry communications strategies to support clinical products and solution education. Critical Skills/technical know-how: Proven writing and editing track record. Highly proficient communicating in English particularly in written format. Generation of clinical-based communications materials. Attention to detail. Proven project management experience. Critical Experience: 3-5 years dental industry professional experience. Experience with presentation of clinical/scientific data and concepts. Experience developing and reviewing clinical content. Experience in customer facing roles. Work experience within a fast moving, international and multicultural/multilingual environment. Operating Company: Nobel Biocare Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.Über das Unternehmen:Nobel Biocare Services AG

 Website Seit der Unternehmensgründung im Jahr 1955 hat sich Oertli von einer Werkstatt für chirurgische Instrumente zu einem der weltweit führenden Anbieter von Geräten und Instrumenten in der Augenchirurgie entwickelt. Die Geschichte von Oertli ist reich an Innovationen, Highlights und wissenschaftlichen Erfolgen. MehrBewerbungsservices Bewerber-Cockpit anlegen  Bewerbungsvideoaufnehmen  Kandidatenprofil erstellenund von Firmen finden lassen  Bewerbungsfoto mit KI erstellen  Zum BewerbungsratgeberMaking the difference with youAls Clinical Affairs Manager bei Oertli prägst du mit deinen klinischen Bewertungen Märkte weltweit. Du hältst unseren Marktzugang durch Berichte zur klinischen Nachbeobachtung aufrecht und erweiterst deine Expertise für die klinischen Funktionen unserer Oertli Produkte. Mach dich bereit die Weichen neu zu stellen und werde Teil unseres Teams und gestalte die Zukunft mit!Clinical Affairs Manager NMPA (China) & MDR (EU)Das kannst Du bewirkenErstellen der klinischen Bewertung für Medizinprodukte unter Berücksichtigung relevanter regulatorischen Anforderungen gemäss EU-MDR, China NMPA und USA-FDA, die den Puls der aktuellen regulatorischen Anforderungen treffen Du tauchst tief in Literaturdaten ein, analysierst klinische und nicht klinische Informationen präzise Mit deinem Talent für Extraktionen und Nachweise dokumentierst du geschickt relevante Daten Klinische Bewertungsberichte verfasst du ebenso überzeugend wie präzise, um die Quintessenz gekonnt zu präsentieren Post-Market Surveillance ist für dich kein Geheimnis - PMS Reports und Periodic Safety Update Reports entstehen unter deiner Federführung Als aktiver Teamplayer gestaltest du interdisziplinäre Produktentwicklungen mit, sei es bei Risikoanalysen oder präklinischen Tests Fachliche Unterstützung der Vigilanz-Verantwortlichen bei klinischen Vorkommnissen mit Bezug auf Klassifizierung im Rahmen der Trendanalyse für die Post-Market Surveillance In enger Zusammenarbeit mit unserem Regulatory Affairs Team unterstützt du weltweit Produktzulassungen Deine Expertise ist gefragt, wenn es um die Validität von Claims und Wirkungsaussagen im Marketing geht Anlaufstelle für klinische Fragestellungen in jeglichen Bereichen inklusive Beratungsfunktion bei Unklarheiten oder RückfragenDas zeichnet Dich ausAbgeschlossenes Masterstudium (MSc) in Biomedizinischen Wissenschaften oder einer ähnlichen Fachrichtung, mit erster Erfahrung in der Bewertung für Medizinproduktezulassungen oder PhD mit erster Berufserfahrung wünschenswert Fundierte Kenntnisse in Literaturrecherche und Medical Writing. Gute Kenntnisse der internationalen Normen und Regularien im Bereich Medizinprodukte und klinische Studien, insbesondere im Kontext der EU-MDR, USA-FDA und China-NMPA. Erste Erfahrung in der Vorbereitung und Einreichung von klinischen Bewertungen von Medizinprodukten in China gemäß NMPA. Erfahrung in der Erstellung von klinischen Bewertungen und Bewertungsberichten (PMS und PSUR) gemäß EU-MDR. Sehr gute Deutsch- und Englischkenntnisse in Wort und SchriftWas Dich bei uns erwartetEine offene Du-Kultur und ein familiäres Miteinander Eine ausführliche Einarbeitung sowie ein individuell gestaltetes Einführungsprogramm mit Einblick in verschiedene Abteilungen Eine sinnstiftende Arbeit, welche das Leben anderer verbessert Mindestens 5 Wochen Ferien sowie Vorholtage flexible Arbeitszeiten und die Möglichkeit, teils bequem aus dem Homeoffice zu arbeiten Unterstützung der beruflichen Weiterentwicklung durch gezielte Aus- und Weiterbildungen Übernahme der Krankentaggeldprämie Kostenlose Parkplätze Kostenlosen Kaffee, Tee und frischen Früchte sowie 15 Minuten bezahlte PauseWeitere Informationen zu unseren Zusatzleistungen findest du hier.Das sind WirIm St. Galler Rheintal entwickelt und produziert die Oertli Instrumente AG modernste Geräte und Instrumente für die Augenchirurgie. Ob in hochmodernen Augenkliniken in Europa, in spezialisierten Kompetenzzentren im arabischen Raum oder bei mobilen Hilfsprojekten im Himalaya - überall tragen unserer Produkte und Lösungen dazu bei, Augenärzte und OP-Personal bei der Erhaltung von Augenlicht und bei der Verbesserung der Sehfähigkeit zu unterstützen.Bereit, die Welt des Augenlichts zu verändern? Dann freuen wir uns auf Deine vollständigen Bewerbungsunterlagen.Für Fragen steht Dir Fabio (HR Business Partner) gerne unter +41 71 747 42 03 zur Verfügung. Direktbewerbungen werden bevorzugt.Arbeitsort: 9442 Berneck (Home Office möglich)18.01.2024 Clinical Affairs Manager NMPA (China) & MDR (EU) 9442 Berneck Festanstellung 80-100% Alle Jobs dieses Anbieters  Meinen Arbeitsweg berechnenJETZT BEWERBENÜber uns Jobs KarriereBenefitsFotos / Videos

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Clinical Development Lead sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. CDLs are matrix leaders and managers who lead, develop, motivate and achieve results through teams; demonstrate a commitment to the development of a resilient attitude, embrace change and have an unwavering commitment to our People Strategy Serves as the clinical point of accountability for the Development Team and is responsible for the overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s) Ensures studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals Serves as a matrix leader to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) Key Responsibilities Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians May serve as CTP as necessary Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function Partners with Worldwide Patient Safety physicians in the ongoing review of safety data Serves as the (co-)leader of the cross-functional Clinical Development Team Provides clinical leadership and disease area expertise into integrated disease area strategies Partners closely with KOLs in specific indications Serves as Primary Clinical Representative in Regulatory interactions Evaluates strategic options against a given Target Product Profile (TPP) Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed Sets executional priorities and partners with CTP and CS to support executional delivery of studies Accountable for top line data with support of CTP, CS, and Statisticians Qualifications & Experience MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge At least 10 years of relevant experience Experience Requirements: CDL has demonstrated leadership in the design and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes: Able to synthesize internal and external data to produce a clinical strategy Able to ensure that the clinical program will result in a viable registrational strategy Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent Verifiable track record of successful people management and development, or leadership in a matrix team (e.g. mentoring junior colleagues) Key Competency Requirements: CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s) External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials) Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables Travel Required Domestic and International travel may be required. The starting compensation for this job is a range from $308,000-354,000 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed. Final individual compensation will be decided based on demonstrated experience. For more on benefits, please visit our https://careers.bms.com/working-with-us. Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Über das Unternehmen:1525 JuN - Seattle Dexter

Wir suchen derzeit einen Clinical Affairs Managerfür einen unserer Kunden im Bereich Medizinprodukte. Ihre Aufgaben:Als Clinical Affairs Manager sind Sie verantwortlich für eine Vielzahl von Aufgaben, die für den Erfolg unserer Produkte von entscheidender Bedeutung sind.Erstellung der klinischen Bewertung für Medizinprodukte unter Berücksichtigung relevanter regulatorischer Anforderungen (EU-MDR, China NMPA und USA-FDA).Tiefe Einblicke in Literaturdaten, präzise Analyse klinischer und nicht klinischer Informationen.Verfassen von überzeugenden und präzisen klinischen Bewertungsberichten.Erstellung von PMS-Berichten und Periodic Safety Update Reports.Interdisziplinäre Mitgestaltung von Produktentwicklungen, einschließlich Risikoanalysen und präklinischen Tests.Fachliche Unterstützung der Vigilanz-Verantwortlichen bei klinischen Vorkommnissen.Unterstützung bei Produktzulassungen in Zusammenarbeit mit unserem Regulatory Affairs Team.Beratungsfunktion bei klinischen Fragestellungen in jeglichen Bereichen. Ihr Profil:Um in dieser Rolle erfolgreich zu sein, benötigen Sie eine Reihe von spezifischen Fähigkeiten und Erfahrungen.Abgeschlossenes Masterstudium (MSc) in Biomedizinischen Wissenschaften oder einer ähnlichen Fachrichtung, mit erster Erfahrung in der Bewertung für Medizinprodukte Zulassungen oder PhD mit erster Berufserfahrung wünschenswert.Fundierte Kenntnisse in Literaturrecherche und Medical Writing.Gute Kenntnisse der internationalen Normen und Regularien im Bereich Medizinprodukte und klinische Studien, insbesondere im Kontext der EU-MDR, USA-FDA und China-NMPA.Erste Erfahrung in der Vorbereitung und Einreichung von klinischen Bewertungen von Medizinprodukten in China gemäß NMPA.Erfahrung in der Erstellung von klinischen Bewertungen und Bewertungsberichten (PMS und PSUR) gemäß EU-MDR.Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift. Wenn Sie sich für diese Position interessieren, senden Sie bitte Ihren Lebenslauf und Ihr Anschreiben an unsere Personalabteilung. Nach der Überprüfung Ihrer Bewerbung werden wir Sie kontaktieren, um ein Vorstellungsgespräch zu vereinbaren. Wir freuen uns darauf, von Ihnen zu hören und mehr über Ihre Qualifikationen und Erfahrungen zu erfahren.

Clinical Research FellowshipThe EOC the multisite hospital of Ticino is present with its institutions on the entire cantonal territory with a total of 1,000 beds. The organization makes it possible to effectively combine local approach and overall vision, guaranteeing the population a comprehensive and proximity hospital offer, regardless of where services are required.Thanks to the commitment and expertise of its more than 5,000 employees and their focus on human relationships, the EOC ensures quality health care for 380,000 patients a year. To complete the team at the Oncological Institute of Southern Switzerland (IOSI) Bellinzona, New Drugs Development Unit, we are looking for a/an Clinical Research Fellowship (100%) The Oncology Institute of Southern Switzerland is one of the largest clinical research centers in Switzerland. Our three main areas of clinical research comprise new drug development, lymphoproliferative diseases (lymphoma and chronic lymphocytic leukaemia) and prostate cancer. Other important areas of development in clinical research include gynecological cancer, breast, lung, skin and gastrointestinal cancer.The IOSI has a dedicated phase 1 unit where early phase clinical trials, including first-in-human, are conducted. We have an excellent history of collaborating with both non-for-profit academic organizations and the pharmaceutical industry. Of particular relevance are our collaborations with the Institute of Oncology Research (IOR), the Institute of Biochemical Research (IRB) and the Swiss Group for Clinical Cancer Research (SAKK). We have a central role in the Faculty of Biomedical Sciences of the Università della Svizzera Italiana (USI). We are offering a Clinical Research fellowship in Drug Development in solid tumors. This fellowship would incorporate activities in the phase 1 Unit of the IOSI and clinical activity. During the fellowship program, there will be the possibility to participate in educational activities performed in our institute and selected external events. Through this fellowship, you will develop your clinical skills, increase your knowledge on how to conduct clinical research and manage patients enrolled in clinical trials, particularly focusing on early phase clinical trials. A minimum commitment of one year is required, to allow you to complete the fellowship objectives. Job Summary/Objectives: Develop clinical expertise in the management of patients with solid tumors enrolled in early phase clinical trials Learn the different aspects of the clinical research, particularly regarding trial design, evaluation of treatment toxicity and efficacy, management of patients enrolled in clinical trials, with a focus on early phase clinical trials of novel therapeutics Participation in study-specific safety calls in collaboration with the principal investigator and the Clinical Research Unit (CRU) team Attend internal meetings and educational activities Partecipate in multidisciplinary tumour boards Partecipations in research projects with clinical or translational objectives Conceptualize and conduct at least one specific research project that is realizable within the period of the fellowship Publish manuscripts in peer-reviewed journals Salary: The per annum rate is approximately 40’000 CHF, the Swiss mandatory health insurancecosts will be deducted from this before payment to the post holder. Candidates receiving agrant from their institution or from a national or international society, will instead have theirgrant topped up to this level. Travel and accommodation costs are considered as includedin this salary and there will be no additional payments made. Eligibility Candidates must be/have:- A medicine degree - Experience in medical oncology of at least 2 years- Proficient in Italian for patients and clinics, minimum B2 level (if non-native Italian speaker)- Proficient in English, as this is the primary language of research and related communications You should also verify your eligibility for registering with (MEBEKO). However, we recommend you do not apply to register with MEBEKO at this point. For more information you can write to the e-mail adress: [email protected], [email protected] or [email protected]. No paper applications will be accepted. EOC - il nostro ospedale. Interessato? Se si riconosce nel profilo e nei valori ricercati, invii la sua candidatura »Indietro