171 Jobs für Clinical Regulatory Affairs Manager
Stellenangebote Clinical Regulatory Affairs Manager Jobs
Job gestern bei StepStone gefunden
ZEISS
• Oberkochen (Baden- Württemberg)
[. .. ] in improving the lives of patients worldwide. The fact that our actions have a direct impact on peoples well-being is what drives us every day. Your Role [...]
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[...] As a Clinical Affairs Manager (m/f/x) , you will play a pivotal role in driving the clinical strategy for the international approval of complex new product developments and product improvements in the ZEISS microsurgery. You will be responsible for defining, planning, and executing all necessary clinical studies and projects worldwide and evaluating clinical [. .. ] product-specific marketing materials and publications Ongoing participation in multidisciplinary project teams involved in product development and product improvements, from initial product definition through to market launch. Support of Clinical/ Regulatory Affairs teams worldwide in product registration efforts Responsibility for adapting and improving Clinical Affairs processes Regular interdisciplinary collaboration and leadership of cross-location projects in the field of Clinical Affairs Successfully completed a degree in a natural science or related field (e. g. , Medicine, Medical Engineering) , or possess [. .. ]
Job am 04.12.2025 bei StepStone gefunden
Ottobock SE Co. KGaA
Go-To-Market Manager Prothetik (d/w/m)
• Duderstadt
Homeoffice möglich Abgeschlossenes Studium
Flexible Arbeitszeiten Betriebliche Altersvorsorge Vermögenswirksame Leistungen
[. .. ] Abteilung für Versorgungsprogramme hat es sich daher zur Aufgabe gemacht, die Behandlungsstandards weltweit zu erhöhen. Für die Entwicklung notwendiger Konzepte und der dazugehörigen Infrastruktur suchen wir einen [...]
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[...] Go-To-Market Manager Prosthetics (d/w/m) . Du fungierst als Schnittstelle zwischen internationalen Vertriebsniederlassungen und unserem Headquarter (Marketing, Clinical Research Services, Operations, Regulatory Affairs, Group Controlling) im Hinblick auf die Überwachung strategischer Initiativen und Markteinführungen Dein Hauptaugenmerk liegt auf Vertriebs- und Marketingstrategien strategisch herausragender Produkte und Initiativen (Downstream) in Abgrenzung zur Bereichsverantwortung des globalen Produktmanagements-wobei der Fokus auf der gesamten Portfoliostrategie und dem Upstream-Marketing liegt Du unterstützt den Head of Go-To-[. .. ]
Job vor 14 Tagen bei Jobware gefunden
TRB Chemedica AG
• Feldkirchen bei München
Homeoffice möglich
30+ Urlaubstage
[. .. ] und behalten auch bei mehreren Projekten den Überblick. Sie haben sehr gute Englischkenntnisse und beherrschen Deutsch auf muttersprachlichem Niveau in Wort und Schrift. . Produktmanager Medizinprodukte (m/w/d) [...]
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[...] Product Manager Pharma/ Healthcare (m/w/d) Brand Manager Healthcare/ Pharma (m/w/d) Marketing Manager Medizinprodukte (m/w/d) Produktmanager Orthopädie (m/w/d) Produktmanager Ophthalmologie (m/w/d) Medical Marketing Manager (m/w/d) Digital Marketing Manager Healthcare (m/w/d) Marketing Communications Manager Healthcare (m/w/d) Content Manager Healthcare/ Pharma (m/w/d) Commercial Product Specialist (m/w/d) Clinical Product Manager (m/w/d) Medical Affairs Manager (m/w/d) Scientific Product Specialist (m/w/d) Medical Science Liaison (m/w/d) (mit leichter Marketingnähe) Medical Content Specialist (m/w/d) Event Congress Manager Healthcare (m/w/d) Healthcare Communications Manager (m/w/d) Education Training Manager Medical Devices (m/w/d) Digital Product Manager Healthcare [. .. ] Commerce Manager Digital Communications Manager Pharma Marketing Automation Specialist Healthcare Scientific Affairs Specialist Clinical Research Associate (mit Produktfokus) Medical Information Specialist Evidence Data Manager Healthcare Clinical Evidence Manager Med Tech Regulatory Product Communication Specialist Medical Event Manager Healthcare Training Coordinator Medical Congress Coordinator Education Specialist Medical Devices Health Communications Specialist Corporate Communications Manager Healthcare 71621652 [. .. ]
Neu Job vor 4 Std. bei Mindmatch.ai gefunden
ZEISS Group
IT Solution Manager
• berlin
Abgeschlossenes Studium Abgeschlossene Ausbildung
Ihre Rolle Gestalten der digitalen Transformation der Carl Zeiss Meditec mit Fokus auf die Bereiche R D, Qualitätsmanagement,
Regulatory Affairs und
Clinical Affairs. Spezifikation und Koordination der Umsetzung von Lösungen [...]
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[...] durch interne und/oder externe Partner sowie die Verantwortung für deren finale Abnahme Fachliche Beratung in globalen Einführungs- und Rollout-Projekten mit Unterstützung externer Berater, interner Prozessexperten/ Key-Usern, usw. Sicherstellung des ordnungsgemäßen operativen Betriebs im Zusammenspiel mit Konzern-IT sowie ggf. [. .. ] vergleichbaren Studiums im IT-Umfeld oder abgeschlossene Ausbildung Fachinformatiker, Informatikkaufmann, IT-System-Kaufmann oder vergleichbarer IT-Hintergrund mehrjährige Berufserfahrung als Requirements Engineer, Business Process Analyst, IT Solution Architect, IT Project Manager oder in einer vergleichbaren Position sehr gute analytische Fähigkeiten in den Bereichen Requirements Engineering und Business Processes ausgeprägte Kommunikations- und Teamfähigkeit ein hohes Maß an Eigeninitiative Einsatzbereitschaft sehr gute Englischkenntnisse einen sicheren Umgang mit ITSM-Prozessen Your ZEISS Recruiting Team: Anne Sophie Günther, Sabrina Rieker 72932370 [. .. ]
Neu Job vor 4 Std. bei Mindmatch.ai gefunden
Smith+Nephew
• deutschland
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Medical Education
Manager (MEM) is responsible for providing
clinical insight and strategic partnership for [...]
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[...] the development, delivery, and implementation of Medical Education for our AWM (Advanced Wound Management) business in Germany, Switzerland and Austria (GSA) . The MEM will focus on driving different Medical Education activities, online and offline, related to AWM across GSA. This role will be responsible [. .. ] potential thought leaders, educators, and/or innovators for relevant areas of clinical practice to support safe and effective use of AWM products Complete annual needs assessment in partnership with Professional Affairs to identify Smith+Nephews needs to engage HCP Consultants to ensure compliant interactions Ensure the logistics related to programs including registrations, course information and post course evaluation data analysis and reporting are managed, reported to partners, and input into relevant regulatory systems Assure process integrity and compliance with local regulations and policies as well as effective use of our Leaning Management System What will you need to be successful? Min. 5 years experience in a similar role in Medical Education/ Clinical Education/ Professional Education or equivalent Very strong skills in project [. .. ]
Job gestern bei Mindmatch.ai gefunden
Syneos Health
Contract Specialist
• münchen, BY
Description Contract Specialist-Germany-hybrid in München Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique
clinical, medical
affairs and commercial insights into [...]
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[...] outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, [. .. ] Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing. Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented. Ensures all project deliverables meet the internal and customers expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and management. Develops and maintains relationships with [. .. ] Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management. If out-of-scope work is requested, notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to back log. Prepares the core submission documents and core clinical trial application dossier for amendments during life cycle maintenance of the projects. Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/ [. .. ]
Job vor 5 Tagen bei Jooble gefunden
Abb Vie Deutschland GmbH Co. KG
• Wiesbaden
Work-Life-Balance
[. .. ] close collaboration with your colleagues. Are you passionate about improving global health care? In a challenging work environment that offers opportunities to develop and increase your own [...]
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[...] skills? Medical Excellence Manager (all genders) Ensure local Medical Excellence Operations activities comply with all Abb Vie processes, the Code of Business Conduct, ethics, regulatory requirements, and local laws Proactively contribute to and implement global strategies in close cross-functional collaboration, supporting best-in-class medical infield team excellence Develop and implement processes, tools, and materials to drive Medical Excellence Lead digital transformation projects (e. g. , Abb Vie internet presence, multi-and omnichannel communication, [. .. ] medical training managers Identify and pursue external project opportunities beyond the pharmaceutical industry Partner with subject matter experts across all therapeutic areas to support scientific communication priorities Advise Affiliate Medical Affairs on medical communication topics Ability to influence without direct authority and effectively deliver cross-functional projects Strong commitment to compliance, scientific quality, and integrity MS, Ph D, MD, Pharm D) preferred Excellent German (written/ spoken) , fluent in English Good experience in project management Strong project planning and management experience, including successful [. .. ]
Job vor 12 Tagen bei Jobleads gefunden
Associate Director, Head of MSL Oncology, Germany
• München, Bayern
Führungs-/ Leitungspositionen
[. .. ] to serving patients worldwide. Please visit for more information. Reporting to the Country Medical Director Germany, the Associate Director, Head of MSL Oncology is accountable for driving [...]
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[...] the Country Medical Affairs strategy and executing programs that support the successful development and commercialization of Jazz Pharmaceuticals oncology portfolio. This role includes direct leadership of the Oncology MSL team. Success in this position requires strong leadership capabilities, a high degree of crossfunctional collaboration, and the ability to influence stakeholders across all levels of [. .. ] a balance between strategic vision and handson execution within a dynamic, fastpaced environment. The incumbent is also responsible for ensuring that all activities are conducted in full compliance with national regulatory and legal requirements, as well as Jazz Pharmaceuticals internal policies and healthcare compliance standards. Essential Functions Leadership and Development of the German Oncology MSL Team Build and lead a highperforming MSL team by consistently applying and exemplifying Jazzs highperformance practices. Establish and maintain effective performance management practices, ensuring clear expectations [. .. ] drive alignment and collaboration. Execution of Medical Strategy and Scientific Excellence Drive the effective execution of the medical strategy and associated plans. Maintain and continuously develop deep expertise in oncologyrelated clinical and scientific literature to position both yourself and the team as trusted subject matter experts. Strategically plan and engage with national Key External Experts (KEEs) to maximize scientific exchange and collaboration. Support data generation initiatives, including the reactive evaluation of Investigator Sponsored Trial (IST) proposals. Uphold the highest standards of [. .. ] deliver highquality scientific and clinical insights that foster KEE advocacy. Required Knowledge, Skills, and Abilities Extensive experience in Medical Affairs within the pharmaceutical industry. Proven leadership experience as a line manager. Prior experience in hematology/ oncology is highly desirable. In-depth understanding of the German healthcare landscape. Strong leadership capabilities with a demonstrated ability to influence across all organizational levels. Excellent interpersonal skills with a collaborative and teamoriented mindset. Ability to critically evaluate and interpret complex scientific data. Outstanding communication and [. .. ]
Job vor 12 Tagen bei Jobleads gefunden
• Cham, Zug
[. .. ] Abb Vie Brand teams and external thought leaders using information that has been reviewed and approved by relevant local procedures, and under the direction, governance and oversight [...]
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[...] of the MSLs manager, therapeutic area Medical Manager, or Affiliate Medical Director as appropriate. This includes working with local Medical Information teams, as appropriate, to respond to unsolicited requests for off-label information on Abb Vie medicines. Develop and maintain collaborative relationships with thought leaders in Gastroenterology, to facilitate Abbvie research and educational priorities [. .. ] members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations. Assist in the initiation; oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility (e. g. post marketing clinical activities such as registry/ database projects, epidemiological surveys, post-authorization studies (phase IV) . All such activities must comply with applicable local laws, guidelines, codes of practice, SOPs, and Abb [. .. ] leaders to facilitate investigator initiated study (IIS) ideas and requests for support to the local and global medical teams as appropriate. Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within western Switzerland in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant Abb Vie medicines, to support their safe, effective and appropriate use. Deliver credible presentations on scientific matters to physicians, individually or in groups [. .. ] communicate, where appropriate, within the Company. Assist physicians with requests for access to Abb Vie medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements. Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice. Qualifications University degree (Masters and/or Ph D preferred) in a relevant scientific discipline First experience in developing [. .. ]
Job am 03.12.2025 bei Jobleads gefunden
Quality Assurance Regulatory Affairs Manager
• Baden- Württemberg
Consultant Medical Devices QARA United States Europe Quality
Regulatory Affairs Manager Class III Cardiovascular Devices Company Type:
Clinical-stage medical device developer focused on structural heart therapies Were partnering with [...]
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[...] an emerging German Med Tech company developing a catheterbased Class III implant for structural heart repair. The device targets a major unmet need in minimally invasive heart valve therapy and is on track for pivotal trials. The company is [. .. ]
Job am 19.11.2025 bei Jobleads gefunden
• Neu- Isenburg, Hessen
Market Access
Manager Dermatology-Nord/West Location: Flensburg, Lübeck, Hamburg, Hannover, Oldenburg Company: LEO Pharma Job ID: 3918 LEO Pharma has embarked on an ambitious journey to become the preferred dermatology [...]
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[...] care partner improving peoples lives around the world and that is why we need you. As Market Access Manager in Germany, you [. .. ] on national market access and reimbursement topics. Your Qualifications Completed university degree in medicine, public health, natural sciences, or comparable training. Industry experience in Market Access, health economics, marketing, sales, regulatory affairs, or clinical research. Knowledge of the German healthcare system. Special knowledge of the work process in Market Access and reimbursementrelevant stakeholders. Targetgroup appropriate communication skills. Sales experience. Relationshipbuilding ability empathy. Stakeholder management network competence. Negotiation and closing confidence. Analytical competence data orientation. Argumentation and persuasion skills. Project and process control. Moderation and [. .. ]
Job am 19.11.2025 bei Jobleads gefunden
Regional Market Access Manager Dermatology-West/ Mitte: Köln, Aachen, Darmstadt, Saarbrücken, Trier
• Neu- Isenburg, Hessen
Market Access
Manager, Germany LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving peoples lives around the world and that is why [...]
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[...] we need you. Responsibilities Definition and development of strategies to support medical personnel, especially regarding occupational dermatology and economic feasibility. Preparation of materials for [. .. ] Managers with national market access and reimbursement topics. Qualifications Completed university study in medicine, public health, natural sciences or comparable education. Industry experience in Market Access, health economics, marketing, sales, regulatory affairs or clinical research. Knowledge of the German healthcare system. Specific knowledge of the way of work in Market Access and reimbursement relevant stakeholders. Knowledge in target group appropriate communication. Sales experience. Relationship skills empathy. Stakeholder management network competence. Negotiation and closing security. Analytical competence data orientation. Argumentation and persuasion power. Project and [. .. ]
Job am 16.11.2025 bei Jobleads gefunden
• München, Bayern
Führungs-/ Leitungspositionen
Director, Field Medical
Affairs (Rare Diseases) Join to apply for the Director, Field Medical Affairs (Rare Diseases) role at Regeneron Were hiring a Medical Director, Field Medical Affairs (Rare [...]
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[...] Diseases) to help advance care in cardiovascular, muscle, and bone conditions. This hybrid role blends strategic medical planning with field-based scientific engagement across select [. .. ] A Typical Day Leading scientific discussions with healthcare professionals and key opinion leaders. Evaluating health technology assessments, reimbursement pathways, and market access strategies. Responding to medical inquiries with accuracy and regulatory compliance. Collaborating across functions to support speaker training and promotional review. Sharing field insights to inform medical planning and product development. Supporting post-approval clinical trials from design to reporting. Partnering with CRO medical monitors and study teams to enhance site engagement. This Role May Be For You If Youre a strategic problem solver who thrives on connecting science with real-world impact. You enjoy building trusted relationships and engaging in scientific dialogue. Youre comfortable [. .. ] most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof) , sex, nationality, national or ethnic origin, civil [. .. ]
Job am 11.11.2025 bei Jobleads gefunden
Legal Director
• Frankfurt, Hesse
Führungs-/ Leitungspositionen
Snr
Manager HR EMEA DLT Mentor, Talent Acquisition Leader, Blockchain Enthusiasts, AI Enthusiast, Personal Finance and Career Coach As the largest provider of health care products and services to [...]
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[...] officebased dental and medical practitioners, Henry Schein Inc. understands what it takes to be successful. Ranked first in its industry on the FORTUNE [. .. ] affecting Henry Schein entities in Europe under any jurisdiction, for example company law, contract law (customers, suppliers, service providers) M A, competition law, IT and data privacy matters, litigation, government affairs or investigations. Essential Duties and Responsibilities Providing European input for global projects on company law, contract law, M A, IT, data privacy, government affairs, litigations, marketing etc. Advising on designing, implementing and monitoring internal process and procedures to ensure compliance with legal requirements and Henry Scheins ethical standards. Cooperating with all functions and local organizations, including region and country leaders and heads of the various European support functions. Working closely with colleagues in the US from Legal, Finance, Tax, Regulatory and Compliance business functions. Working with partners and associates of external law firms and representatives of suppliers and business partners. A law degree, admission to practice as a solicitor/ attorney in Germany with at least 5 years of professional experience in an international environment. German and English business language skills [. .. ] 000 Team Schein Members worldwide. The companys network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes. The companys Business, Clinical, Technology, and Supply Chain solutions help officebased dental and medical practitioners work more efficiently so they can provide quality care more effectively. These solutions also support dental laboratories, government and institutional health care clinics, as well as other alternate care sites. Henry Schein operates through [. .. ]
Job am 01.11.2025 bei Jobleads gefunden
• München, Bayern
Führungs-/ Leitungspositionen
[. .. ] As the Executive Director Medical Oncology for Germany, you will be responsible for leading the medical strategy and activities related to oncology within the country. Reporting directly [...]
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[...] to the General Manager, you will act as the key medical expert, ensuring scientific excellence, compliance, and alignment with the companys global and regional strategies while addressing local needs. In this role you will also interact closely with the regional Medical Head Oncology and global therapeutic leads. This role requires a strong combination of [. .. ] patient-centricity Represent the medical function in senior leadership discussions and contribute to the overall business strategy for Germany Serve as the primary medical expert in oncology, providing scientific and clinical insights to internal and external stakeholders Build and maintain strong relationships with key opinion leaders (KOLs) , healthcare professionals (HCPs) , patient advocacy groups, and other external stakeholders in Germany Collaborate with clinical development and operations teams to support and accelerate global clinical trials executed in Germany Ensure compliance with ethical and regulatory standards in all research activities and medical governance Build and develop the medical team in Germany, fostering a culture of collaboration, innovation, and excellence Qualifications Medical degree (MD) or equivalent is required; an advanced degree in oncology, clinical research, or related field is preferred (e. g. , Ph D, MBA) Minimum of 10 years of experience in medical affairs, clinical development, or related roles within the pharmaceutical or biotechnology industry, with at least 5 years focused on solid tumors Proven track record of leadership in oncology, including strategic planning and execution Experience in engaging with KOLs, HCPs, medical societies, and regulatory authorities in Germany Expertise in the field of [. .. ]
Job am 25.09.2025 bei Jobleads gefunden
Senior Product Manager (Remote)
• München, Bayern
[. .. ] Developing and executing strategic and tactical marketing plans tailored to the DACH markets. Adapting global brand strategies to local market needs, ensuring cross-functional alignment with Medical, Market [...]
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[...] Access, and Regulatory teams. Leading peer-to-peer engagement and support program strategies across the region. Executing marketing tactics aligned with market needs and measuring their effectiveness using appropriate KPIs. Driving initiatives to support early patient identification and increase therapy duration. Organizing and managing external events, congresses, and KOL engagement. Collaborating with cross-[. .. ] the world. Selecting us as an employer secures acareer inwhich youre guaranteed to: Syneos Health is a leading fully integrated biopharmaceutical solutions organization builtto accelerate customer success. We translate unique clinical, medical affairs and commercialinsights into outcomes to address modern market realities. To learn more about how we are Shortening the distance from lab to life, visit syneoshealth. com. Syneos Health is an Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, age, religion, marital status, ethnicity, [. .. ]
Job gestern bei Jobware gefunden
Fresenius Kabi
• Oberursel
Werkstudenten
[. .. ] Persönlichkeiten und Einstellungen. Weltweit engagieren wir uns für unser zentrales Anliegen: caring for life. . . . +-Oberursel/ Hessen Befristet Teilzeit Ab sofort Werkstudent (m/w/d) Safety in [...]
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[...] Clinical Trials Data Management/ MSASie haben eine sorgfältige Arbeitsweise und Spaß an der Archivierung von Dokumenten? Dann unterstützen Sie zum nächstmöglichen Zeitpunkt unser Office Administration Team im Bereich Clinical Trials Data Management/ Medical Scientific Affairs Im Rahmen Ihres Einsatzes erhalten Sie interessante Einblicke in die Arbeit eines medizinisch-wissenschaftlichen Archivs in einem internationalen Gesundheitskonzern. So können Sie praktische Erfahrungen sammeln, erste Kontakte knüpfen und ganz nebenbei Ihre Studienkasse füllen. Ihre Herausforderung im Detail Sie unterstützen unser Team tatkräftig bei der Langzeitarchivierung der Studienunterlagen sowie bei [. .. ] dieser Seite finden Sie Antworten FAQ Fresenius Karriere Jetzt bewerben Diesen Job empfehlen Anzeige drucken Ihr Kontakt Isabell Kuhn Fresenius SE Co. KGa AOberursel Kennziffer 59312 Auf einen Blick Karrierelevel:Studierende Einsatzbereich:Medizin, Projektmanagement, Regulatory Affairs/ Safety, Sekretariat/ Assistenz, Klinische Studien/ Statistik, Qualitätsmanagement/ Umwelt, Medizintechnik Arbeitsverhältnis:Werkstudententätigkeit/ Teilzeit Unternehmensbereich:Fresenius Kabi Standort:Oberursel/ Hessen Bewerbungsfrist:keine-Wir freuen uns auf Ihre Bewerbung Weitere Informationen Unser Fresenius-Fairness-Versprechen Informationen zum Bewerbungsprozess Unsere Leistungen im Überblick Spannende Projekte, vielfältige Themen und die Lebensqualität von Patientinnen und Patienten verbessern-das ist [. .. ] Bringen Sie sich aktiv ein und unterstützen Sie mit Ihren Ideen an der Entwicklung wegweisender Produkte, Dienstleistungen und Therapien zur Versorgung kritisch und chronisch kranker Menschen. Isabell Kuhn (Junior HR Manager) Fresenius Kabi ist ein weltweit tätiges Gesundheitsunternehmen, das Medikamente und Medizinprodukte zur Infusion, Transfusion und klinischen Ernährung anbietet. Unsere Produkte und Dienstleistungen werden in der Therapie und Versorgung von kritisch und chronisch kranken Patienten eingesetzt. fresenius-kabi. de Offen für Individualität und Vielfalt Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Medical Affairs Manager
[. .. ] the job poster from K-Recruiting Life Sciences We unite the people who make our world healthier by placing top experts with life sciences companies worldwide. Precise. Fast. [...]
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[...] Accurate. Medical Affairs Manager (m/f/D) Tasks : Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation Lead to ensure PRO strategy is conducive to e PRO implementation capabilities Review trial statistical analysis plans for PROs to ensure that proposed analyses match with PRO endpoints as per protocol Review PRO-related TFL shells and actual results once [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ]
Job gestern bei Jobleads gefunden
Senior
Regulatory Affairs Manager Food and Food Contact Materials (FFCM) Join us as a Senior Regulatory Affairs Manager in the Food and Food Contact Materials (FFCM) division at Knoell. Knoell [...]
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[...] is a leading global service provider in regulatory registration, clinical development, and product development support. As a familyowned business, we take pride in our commitment to the highest standards and believe that people are at the heart of our success. Your Role Key Responsibilities Oversee the registration and authorization process for novel foods, food enzymes, food additives, and/or dietary [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Senior Clinical Data Team Lead (Senior DTL) - FSP
• Frankfurt, Hesse
Führungs-/ Leitungspositionen
Senior
Clinical Data Team Lead (Senior DTL) - FSP Be among the first 25 applicants. The Sr. CDM will lead and contribute to data management activities in support of [...]
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[...] Clients studies across all stages of clinical drug development. Summary of Key Responsibilities Contribute to data management activities as a lead study data manager in support of Clients clinical studies. Lead database build activities including leading crossfunctional review of e CRF content, review of edit check specifications, and perform user acceptance testing. Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews. Oversight of database lock activities and ultimate archiving of study data. Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, Regulatory Affairs, CROs, central and local laboratories, and other vendors. Establish crossfunctional, internal data review plans, coordinate data cuts/ transfers, and conduct data reviews. Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation. Contribute to development and implementation of department workflows and infrastructure strategy (such [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Manager Clinical Regulatory Affairs Software (m/w/d)
• Leipzig, Sachsen
Homeoffice möglich Abgeschlossenes Studium
Sabbaticals
[. .. ] in Leipzig, Berlin, Hannover, München oder im Home Office. Dein zukünftiges Team Wir suchen Unterstützung rund um das Thema Zulassung unserer Medizinprodukte mit Schwerpunkt klinische Bewertung und [...]
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[...] technische Dokumentation Als Manager für klinische und regulatorische Angelegenheiten bist du zuständig für die Betreuung der technischen Dokumentation sowie für die Aktualisierung der klinischen Bewertungen unserer Medizinprodukte (Softwarelösungen) . Du übernimmst eine zentrale Rolle in unserem Unternehmen, arbeitest eng mit deiner Führungskraft (Management Representative/ Bo L) , der Geschäftsführung, deinen Teamkolleginnen sowie Spezialistinnen aus anderen [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
Clinical Research Associate
• Hamburg
Veeda Lifesciences is seeking a
Clinical Research Associate (CRA) based in Germany for its growing international hematology/ oncology Clinical Trials program. This is a full-time job. Job Overview The [...]
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[...] CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/ amendments, ICH GCP [. .. ] above In case of deviation from the approved protocol, ICH GCP guidelines and/or applicable legislation during the study conduct, the CRA is responsible for reporting it to the Line Manager and other applicable roles according to SOPs Conducts pre-study visits at potential investigational sites, to perform the study related feasibility and/or selection activities and evaluate their resources and facilities Collaborates with the Regulatory Affairs Department and concerned Clinical Operations staff for clinical submissions and contracts respectively for : Managing Hospital IEC study submissions and approvals with follow through to ensure successful outcome Preparation of study contracts relevant files to be submitted for the study financial management acceptance, as required by the applicable local legislation [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Clinical Research Associate
• Dortmund, Nordrhein- Westfalen
Veeda Lifesciences is seeking a
Clinical Research Associate (CRA) based in Germany for its growing international hematology/ oncology Clinical Trials program. This is a full-time job. Job Overview The [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/ amendments, ICH GCP [. .. ] above In case of deviation from the approved protocol, ICH GCP guidelines and/or applicable legislation during the study conduct, the CRA is responsible for reporting it to the Line Manager and other applicable roles according to SOPs Conducts pre-study visits at potential investigational sites, to perform the study related feasibility and/or selection activities and evaluate their resources and facilities Collaborates with the Regulatory Affairs Department and concerned Clinical Operations staff for clinical submissions and contracts respectively for : Managing Hospital IEC study submissions and approvals with follow through to ensure successful outcome Preparation of study contracts relevant files to be submitted for the study financial management acceptance, as required by the applicable local legislation [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Senior Manager, Regulatory Labelling
• Düsseldorf, Nordrhein- Westfalen Duesseldorf
Job Title : Senior
Manager,
Regulatory Labelling Location : Germany, Fully Remote Salary : Competitive Salary + Excellent Benefits Employee Type : Permanent As a Senior Manager, Regulatory [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Labelling, you will take leadership on everything related to Regulatory Labelling. This includes inputting from a regulatory labelling perspective on developing and established drug programs and being accountable [. .. ] PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed. Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control. Utilize regulatory/ product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines. Skills and Experience University Degree in a scientific degree. Experienced in the following : CCDS, PIL, USPI, Target label profiles. 5+ years of experience in drug development especially in labelling, product package coordination, clinical supplies/ packaging, supply chain regulatory affairs, or quality. Good working knowledge of key labeling regulations/ guidance and past experience in label development The ability to research and create comparator labeling documents Electronic document management systems use and/or electronic submission experience Solid understanding of requirements for tracking of labeling updates. [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Clinical Research Associate
• Leipzig, Sachsen
Veeda Lifesciences is seeking a
Clinical Research Associate (CRA) based in Germany for its growing international hematology/ oncology Clinical Trials program. This is a full-time job. Job Overview The [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/ amendments, ICH GCP [. .. ] above In case of deviation from the approved protocol, ICH GCP guidelines and/or applicable legislation during the study conduct, the CRA is responsible for reporting it to the Line Manager and other applicable roles according to SOPs Conducts pre-study visits at potential investigational sites, to perform the study related feasibility and/or selection activities and evaluate their resources and facilities Collaborates with the Regulatory Affairs Department and concerned Clinical Operations staff for clinical submissions and contracts respectively for : Managing Hospital IEC study submissions and approvals with follow through to ensure successful outcome Preparation of study contracts relevant files to be submitted for the study financial management acceptance, as required by the applicable local legislation [. .. ]
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Wieviel verdient man als Clinical Regulatory Affairs Manager pro Jahr?
Als Clinical Regulatory Affairs Manager verdient man zwischen EUR 60.000,- bis EUR 90.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Clinical Regulatory Affairs Manager Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 171 offene Stellenanzeigen für Clinical Regulatory Affairs Manager Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Clinical Regulatory Affairs Manager Jobs?
Aktuell suchen 23 Unternehmen nach Bewerbern für Clinical Regulatory Affairs Manager Jobs.
Welche Unternehmen suchen nach Bewerbern für Clinical Regulatory Affairs Manager Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Clinical Regulatory Affairs Manager Stellenangebote:
- K- Recruiting Life Sciences (11 Jobs)
- Cpl Life Sciences (11 Jobs)
- Veeda Lifesciences (11 Jobs)
- wax. (11 Jobs)
- Astra Zeneca (10 Jobs)
- TRB Chemedica AG (2 Jobs)
In welchen Bundesländern werden die meisten Clinical Regulatory Affairs Manager Jobs angeboten?
Die meisten Stellenanzeigen für Clinical Regulatory Affairs Manager Jobs werden derzeit in Bayern (32 Jobs), Nordrhein-Westfalen (23 Jobs) und Baden-Württemberg (15 Jobs) angeboten.
Zu welchem Berufsfeld gehören Clinical Regulatory Affairs Manager Jobs?
Clinical Regulatory Affairs Manager Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
