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Pharmazie: 35 Jobs in Garching bei München

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Pharmazie

Sr Manager, Labeling Operations (Regulatory Affairs) (m/w/d)

Di. 07.12.2021
München
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. The Senior Manager, Regulatory Affairs Labeling Operations will be responsible for regulatory support (both technical and operational) in the area of product labeling for Jazz Pharmaceuticals. This position reports to the Associate Director, Labeling Operations and will be responsible for the creation and maintenance of regulatory text within printed labeling materials throughout the product lifecycle, with primary focus on packaging and artwork for products marketed globally. This role will help maintain controlled records for present and historical labeling changes, and communicate labeling changes to stakeholders at the time of implementation. As needed, the Senior Manager will also support the implementation process improvement changes to increase the efficiency and effectiveness of the label review process. This position will interact with Regulatory Affairs colleagues and interact cross-functionally with members of the Commercial, Quality, and Supply Chain organizations.Essential Functions Maintain controlled records for historical, current, and ending labeling changes, and communicate labeling changes to stakeholders at the time of implementation Represent Labeling function within change control management of printed materials Support assigned team(s) by leading activities to ensure timely and compliant implementation of printed labelling materials (for both new commercial products and as a result of labeling variations and regulatory filing activities from a labeling perspective) Manage collaborative and solution-focused communication among all stakeholders Support the process for linguistic review and translation of label content Maintain a current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to product labeling. Interpret and communicate health authority perspectives to relevant stakeholders and recommend policy and/or process changes as needed. Develop and provide metrics and reports related to labeling operational processes and systems to leadership and key stakeholders, as required Management of product information on corporate labeling webpages, as well as participating in audit and inspections as required. Assist in implementing process improvements to increase the efficiency and effectiveness of the label artwork process. Responsible for labeling implementation into printed materials, to ensure that labeling documents are produced in a timely manner according to internal SOPs and external regulatory requirements. Responsible for proofreading and departmental QC work. Lead and manage more junior labeling roles as required. Experience in the pharmaceutical industry, with direct experience in Global Labeling or in other regulatory affairs function(s). Proven experience in regulatory affairs with particular focus on labeling. Experience associated with global product labeling regulations strongly desired. Strong judgement and decision-making skills. Excellent verbal and written communication skills and collaborative interpersonal skills. Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies. Must be able to work successfully within a team/partnership environment and as an individual contributor, with a high level of professionalism. Ability to travel occasionally – approximately 10-20% regional and/or international travel. Responsibilities may require working outside of “normal” hours, in order to meet business demands. Required/Preferred Education and Licenses Bachelor’s degree required (Scientific discipline preferred) (or equivalent industry related experience) Jazz Pharmaceuticals is an Equal Opportunity Employer.
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Scientist - Translational Research & Toxicology (m/f/x)

Di. 07.12.2021
Martinsried
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. Do you want to join global pharmaceutical company but prefer small team with entrepreneurial spirit? Could you already collect experiences with project lead but don´t want to miss the work at the bench? Join our Tissue & Cell Research Center, a pre-clinical R&D unit specialized in innovative research using human tissues and primary cells, based in Martinsried by Munich. To support the advancement of our oncology pipeline we are seeking for: Scientist - Translational Research & Toxicology (m/f/x) Design, execute and monitor in vitro research projects, provide results within given timelines to support the global R&D especially medicinal safety and ADME Develop and validate fit-for-purpose human-based in vitro assays to assess tissue-specific effects of novel therapeutic agents (i.e. antibody-drug conjugates) Document, evaluate, interpret and present the study results in internal and external meetings Prepare and review reports and protocols to ensure the quality and integrity of data Be a collaborative team member, provide scientific and technical support for colleagues Work in team with research assistants but also conduct hands-on laboratory experiments Serve as a partner for daily communication with scientists in R&D Center in Tokyo Maintain expertise in the field through literature reviews, attending relevant meetings, and liaison with external experts in the field Doctoral degree in Life Sciences and several years of relevant working experience in pharmaceutical industry, biotech or academia Demonstrated experience in toxicity assessment, assay development and validation Hands-on laboratory experience in primary cell isolation and culture as well as immunoassays or cell-based assays Excellent organizational skills paired with the ability to work on multiple tasks simultaneously Ability to work in a global environment Strong team player, open minded, showing a proactive approach and accountability Excellent command of the English language - knowledge of the German language is a plus Competitive Pay Work-Life-Balance Growth and Development Health and Family Working at Daiichi Sankyo: At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.
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Mitarbeiter im Facharzt Außendienst / Urologie/Allgemeinarzt (m/w/d)

Mo. 06.12.2021
Berlin, München, Hamburg, Lübeck, Schwerin, Mecklenburg, Rostock, Greifswald, Hansestadt, Neubrandenburg, Mecklenburg, Bremen
Die MiP Pharma Unternehmensgruppe ist ein international aufgestelltes mittelständisches Pharmaunternehmen mit Sitz, Entwicklung und auch Produktion in Deutschland. Mit unserem 270-köpfigen Team leisten wir einen zuverlässigen und nachhaltigen Beitrag zur Arzneimittelversorgung in Deutschland und Europa. Dank unserer anerkannt hohen Liefertreue und Kundenorientierung wurden wir mehrfach als „Bester Pharmalieferant“ im Klinikbereich in Deutschland ausgezeichnet. Werden Sie Teil unseres Teams! Qualifizierte Mitarbeiter, moderne Produktionsanlagen und effiziente Prozesse sowie eine wertschätzende und leistungsfördernde Unternehmenskultur sind Basis unseres Erfolgs. Wir bieten ein modernes Arbeitsumfeld in der Zukunftsbranche Gesundheitswesen, in dem Respekt und konstruktives Miteinander im Team gelebt werden. Im Zuge unseres Wachstums suchen wir zum nächstmöglichen Zeitpunkt für die Regionen Saarland, Berlin, München, Hamburg, Lübeck- Schwerin- Rostock- Greifswald- Neubrandenburg, Bremen- Oldenburg- Bremerhaven, Ruhrgebiet Ost- Dortmund, Ruhrgebiet SüdWest – Düsseldorf und Ulm- Ravensburg mehrere: Mitarbeiter im Facharzt Außendienst Urologie/Allgemeinarzt (m/w/d) Schnittstelle zwischen Pharmaunternehmen, Ärzten sowie Apotheken Aktive Beratung von Ärzten und Apothekern Aufbau und Pflege von Kundenbeziehungen Identifikation möglicher Chancen und Nutzung von Netzwerkstrukturen Individuelle Betreuung von Arztpraxen und Apotheken mittels digitaler Medien Vorträge und Kurz-Referate bei Ärzten und Apothekern Koordination von Besuchsterminen Dokumentation der Ergebnisse Abgeschlossenes Studium der Medizin/ Pharmazie/Biologie oder eine abgeschlossene Ausbildung als Pharmareferent/-in Idealerweise erste Erfahrungen im Pharma-Außendienst Kommunikative Persönlichkeit und selbstständige Arbeitsweise Flexibles Handeln und entsprechende Mobilität Souveräner Umgang mit MS-Office und CRM Systemen Spannende Tätigkeiten mit viel Eigenverantwortung und Gestaltungsspielraum Außergewöhnlicher Teamspirit über alle Fachbereiche hinweg in einer werteorientierten Unternehmenskultur Zukunftssichere Festanstellung in einem dynamisch wachsenden Unternehmen Vielfältige Weiterbildungsmöglichkeiten Eine attraktive Vergütung, 30 Tage Urlaub sowie die Möglichkeit des Fahrradleasings
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Senior Manager CMC Regulatory Affairs (m/f/x)

Sa. 04.12.2021
München
Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world”. In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society”. For our headquarter in Munich we are seeking highly qualified candidates to fill the position: Senior Manager CMC Regulatory Affairs (m/f/x) The Senior Manager Regulatory Affairs CMC will provide European regulatory CMC guidance and strategy for assigned products and will represent Regulatory Affairs CMC EU in internal and external interactions (e.g. global and local project teams, working teams, authorities interactions (Scientific Advice), CMOs). The function will support or lead the preparation of regulatory CMC documents during development and life cycle management in a manner that is scientifically sound, commercially viable and in accordance with regulatory CMC standards. He/She may act as a specialist for biological products in the EU regulatory CMC field. The function communicates EU and international regulatory requirements to authoring teams, develop the EU regulatory strategies and review dossiers and technical documents. The function and the team collaborates companywide within the global RACMC department and technical functions. The function is proactively influencing the internal, but also external regulatory affairs environment. Roles and responsibilities: Working in regulatory teams to conduct preparation of M2 and M3 CTD documents for EU MAAs and IMPDs filings of new drugs, incl. Quality Overall Summary (QOS) Represent EU RACMC function in global RACMC and CMC development teams and provide CMC regulatory guidance and strategy Review CMC documents, develop regulatory strategies, provide risk assessments Support the preparation and execution of Health Authority meetings Interpret, develop strategy and lead response preparation on Health Authorities information requests Keep close collaboration with global RACMC colleagues and technical experts, across all regions Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders Participate or lead assigned non-project tasks and process improvements Ensure maintenance of the regulatory compliance Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus Minimum of 5 years of experience in the pharmaceutical industry Minimum of 3 years of experience in global regulatory affairs CMC with emphasis on late stage CMC drug development and marketing authorization applications in Europe; experience in the development of biologics preferred Proven ability to plan, coordinate and lead activities simultaneously on multiple projects Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation Experience of working in global environment in interdisciplinary teams Experience of working in or leading interdisciplinary teams Solution and detail-oriented; well organised and self-motivated Excellent written and oral communication skills in English, German as a second language preferred Strong working knowledge of Microsoft Office We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.
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Senior Manager Regulatory Affairs Oncology (m/f/x)

Sa. 04.12.2021
München
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For our Headquarter in Munich we are seeking two highly qualified candidates to fill the position: Senior Manager Regulatory Affairs Oncology (m/f/x) To provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a multi-disciplinary team, providing expertise on regulatory matters. Represent Regulatory Affairs in external interactions (e.g. authorities, affiliates, partners, CROs) providing expertise on regulatory strategy to achieve regional and global goals. Role and Responsibilities European regulatory strategy support for assigned projects, covering product development plans, clinical trials and Marketing Authorizations Applications (MAA) as well as product life cycle management. European Regulatory Affairs representation on global development teams providing regulatory guidance and strategy and supporting EU MAA submissions Act as regulatory contact person for authorities for assigned projects Participate in assigned non-project tasks and process improvements Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus Minimum of 8 years of experience in the pharmaceutical industry and minimum of 5 years of experience in global regulatory affairs with emphasis on late stage drug development and marketing authorization applications in Europe, experience with clinical trials, orphan drugs and pediatric clinical development Experience of working in global environment as well as with National Health Agencies and EMA Proven ability to plan, coordinate and lead activities simultaneously on multiple project Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner Solution and detail-oriented; well organised and self-motivated Excellent written and oral communication skills in English, second language preferred Competitive Pay Work-Life-Balance Growth and Development Health and Family Working at Daiichi Sankyo: At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.
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Personalreferent (m/w/d) mit Schwerpunkt Recruiting

Fr. 03.12.2021
Martinsried
Proteros is a privately held early-stage services provider in structure-based drug discovery with a cutting-edge discovery engine tailored to unlock even the most technically challenging targets. Proteros’ work is built on scientific excellence and supports its clients to reach the right results and accelerate their overall research timelines. Proteros supports most of the world’s 20 largest pharma companies and more than 250 pharmaceutical and biotech partners in the US, Europe and Japan. For more information please visit www.proteros.com. SENIOR PROJECT MANAGER (M/F/D) IN EARLY STAGE DRUG DISCOVERY Project Management of Discovery Solutions (Early Stage Drug Discovery) and Structural Biology projects within the scope of our business approach, including customer interaction with international Pharma and Biotech companies in the US and EU Acquisition of Early Drug Discovery Projects Lead multi-disciplinary scientific teams Suggest suitable solutions and technological approaches according to target/customer needs Drive projects from gene to qualified hits according to research target profile (RTP) including mode of inhibition/action, biophysical validation and structures Hands-on experience in industrial drug discovery, including protein sciences, biophysical/biochemical assays, and structural biology Prior minimum of 2-years experience in pharma, biotech, CRO, or academia in Biophysics/Structural Biology PH.D. degree in in Biochemistry, Molecular Biology, Biophysics, Structural Biology, Medicinal Chemistry, or related fields, post-doc experience Good understanding of small molecule drug discovery processes including enabling technologies in the areas of protein sciences, structural biology, and biophysical/biochemical assays and Hit identification Ability to manage multiple complex projects simultaneously with internal and external stakeholders and eagerness to move projects to completion Able to envision a project as a “whole package”, anticipate problems/bottlenecks, and mitigate risks Service mindset Excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company Demonstrated strong sense of responsibility and collaboration, and excellent analytical skills an innovative profession in an exciting industry an inspiring working atmosphere as fertile ground for your further development a comprehensive training that prepares you optimally for your area of responsibility multicultural teams and an open corporate culture
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Pharmazeutischer Mitarbeiter PTA / PKA (m/w/d) 2nd Level Support

Fr. 03.12.2021
Fürth, Bayern, München, Nürnberg, Stuttgart
Werden Sie ALL IN! for Health als Pharmazeutischer Mitarbeiter PTA / PKA (m/w/d) 2nd Level Support Die Entwicklung von innovativen und intelligenten Lösungen für den effizienten Ablauf im Apothekenalltag ist unsere Mission! Wir stehen dazu in direktem Austausch mit unseren Kunden, um unsere Produkte fortlaufend zu optimieren. Unsere Hard- und Softwareprodukte bieten Apotheken Zuverlässigkeit und Sicherheit - genau wie unsere Mitarbeitenden, die Ihr Fachwissen verantwortungsvoll einsetzen. Werden Sie jetzt Teil unseres Teams! Ihr Beitrag: Sie bearbeiten telefonisch und schriftlich die Anfragen aus unserem 1st Level Support und geben weiterführende Hilfestellung sowie Lösungen Sie übernehmen komplexe Anfragen und unterstützen unsere Kunden bei Fragen zu unserem Warenwirtschaftssystem WINAPO®, unseren Betriebssystemen und unserer Hardware Sie dokumentieren Ihre Tätigkeiten über SAP-CRM und verarbeiten Ihre Lösungsansätze z. B. in Form von F.A.Q. Einträgen Im Rahmen der Produktverbesserung und bei speziellen Anliegen arbeiten Sie eng mit anderen Fachabteilungen zusammen, z. B. in der Testung und Dokumentation von Programmfunktionen Das bringen Sie mit: Sie verfügen über eine abgeschlossene Ausbildung im pharmazeutischen Bereich, z. B. als Pharmazeutisch-technischer Assistent (m/w/d), Pharmazeutisch-kaufmännischer Angestellter (m/w/d), oder bringen eine gleichwertige Qualifikation mit Sie besitzen gute IT-Kenntnisse (Excel/ Word) und haben idealerweise bereits Erfahrung im Gesundheitswesen Sie arbeiten gerne im Team und zeichnen sich durch Ihre selbständige und lösungsorientierte Arbeitsweise aus Das können Sie von uns erwarten: Einen sicheren digitalen Bewerbungs- und Onboarding-Prozess während der COVID-19 Pandemie Einen krisensicheren und unbefristeten Arbeitsplatz Ein ausgereiftes Service- und Supportkonzept leistet Ihnen umfangreiche Unterstützung Vielfältige Weiterentwicklungsmöglichkeiten und langfristige Perspektiven innerhalb unseres wachsenden Unternehmens Digitales Feel Good Management mit vielfältigen Angeboten für Ihre Gesundheit, z. B. Home-Workouts, Ernährungsberatung, Mentaltrainings, etc. Moderne Arbeitsplätze, Vertrauensarbeitszeit, Mobiles Arbeiten, Mitarbeiterrabatte, u. v. m. sorgen für ein angenehmes Arbeitsumfeld Überzeugt? Bewerben Sie sich online mit Ihren aussagekräftigen Bewerbungsunterlagen (inkl. Gehaltsvorstellung und nächstmöglichen Eintrittstermin). Synchronizing Healthcare Werden Sie ALL IN! mit Kopf, Herz und Hand
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Head of Quality Management (m/w/d)

Do. 02.12.2021
Ottobrunn
Minaris Regenerative Medicine GmbH ist ein globaler Partner für Auftragsforschung und Lohnherstellung. Wir produzieren hochmoderne Zell- und Gentherapien nach den Vorgaben der Guten Herstellungspraxis (GMP) für die Anwendung im Menschen. Bei uns tragen Sie aktiv zum medizinischen Fortschritt bei und geben schwer kranken Patienten Hoffnung. Weitere Informationen finden Sie auf unserer Webseite rm.minaris.com. Unter „Bewerben“ können Sie mit nur wenigen Klicks Ihren Lebenslauf hochladen. Wir freuen uns auf Sie! Zur Verstärkung unseres Management Teams am Standort Ottobrunn suchen wir eine/n: Head of Quality Management (m/w/d) Strategische wie operative Weiterentwicklung des GMP konformen Qualitätsmanagementsystems für die Herstellung von Zell- und Gentherapeutika (ATMP’s) Prozessverantwortung für sämtliche Prozesse des QM-Systems Sicherstellung und Optimierung der Schnittstellen des Qualitätsmanagements zu benachbarten Abteilungen Planung, Vorbereitung und Durchführung von (internationalen) Kundenaudits und Behördeninspektionen Durchführung von Audits für die Qualifizierung von Lieferanten und Prüflaboren Führen, Fördern und Weiterentwickeln der Mitarbeiter im Verantwortungsbereich Verantwortliche Erstellung des jährlichen Budgets einschließlich Personalplanung und Investitionen für den eigenen Bereich Abgeschlossenes pharmazeutisches oder naturwissenschaftliches Studium oder vergleichbare Qualifikation Mehrjährige Berufserfahrung in der Ausübung der Tätigkeit als Leiter der Qualitätssicherung oder -kontrolle im Bereich der Arzneimittelherstellung oder -prüfung oder vergleichbare Qualifikation Erfahrung im Bereich der Arzneimittel für neuartige Therapien (Advanced Therapy Medicinal Products, ATMPs) wünschenswert Hohe fachliche Kompetenz und tiefe Kenntnis der gesetzlichen Vorschriften im Bereich Arzneimittelherstellung, -prüfung und -freigabe Mehrjährige Erfahrung in der Analytik gemäß § 15 AMG im Hinblick auf eine mögliche Erlangung der Sachkenntnis zur Sachkundigen Person gemäß § 14 AMG von Vorteil Führungsexpertise und damit verbunden die Fähigkeit, Ihr Team zu fördern und zu motivieren um Höchstleistungen im Sinne der vereinbarten Ziele in einem dynamischen Umfeld zu erbringen Flexibilität, Lösungsorientierung und Prozessaffinität und ein ausgeprägtes Maß an Qualitäts-, Kunden- und Zielorientierung Verhandlungssichere Englischkenntnisse in Wort und Schrift sowie gute IT-Kenntnisse Ein starkes Team, das zum medizinischen Fortschritt beiträgt Ein spannendes und innovatives Umfeld mit zahlreichen Gestaltungs- und Entwicklungsmöglichkeiten Teil des japanischen Konzerns Showa Denko Materials Co., Ltd 13 Gehaltszahlungen Betriebliche Altersvorsorge, Vermögenswirksame Leistungen Zuschuss zur Kinderbetreuung Diverse Mitarbeitervergünstigungen
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Global Patient Safety (GPS) Senior Scientist (gn)

Do. 02.12.2021
Planegg
MorphoSys’ mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich! We would like to fill the following vacancy as soon as possible: Global Patient Safety (GPS) Senior Scientist (gn) You will be a core member of the relevant product-specific Safety Management and Review Team(s) (SMART) Provide technical safety expertise to ensure the scientific integrity and quality of all relevant safety-related clinical development and post-marketing activities and deliverables Responsible for but not exclusively: All relevant safety-related clinical trial activities and deliverables, including writing relevant sections of clinical trial protocols and related documents (member of the respective cross-functional Clinical Trial Teams) Safety signal management Benefit-risk evaluations Definition and implementation of pharmacovigilance and risk minimisation activities Health Hazard Evaluations for Product Quality Concerns Responses to safety-related questions from health authorities Provide state-of-the-art safety scientific methodology for safety data analysis, visualization and interpretation, collaborating closely with biostatistical colleagues Provide technical / scientific expertise to the development and implementation of new tools, e.g. safety data analysis and visualization tools Present safety-related data, information and messages to internal and external audiences as required Demonstrate knowledge of, and ensure compliance with company guidelines, policies and procedures and be able to demonstrate this during health authority inspections A higher qualification (Masters degree or PhD or equivalent) in a bioscience subject, or pharmacy Professional Experience: Good understanding of the pharmaceutical industry Sound knowledge and understanding of industry and pharmacovigilance legislation, including ICH-GCP and clinical safety guidelines, EU Clinical Trials Regulation and EMA GVP Modules, and FDA clinical safety and risk management guidance, and the need for compliance with these Extensive experience in pharmacovigilance/patient safety, plus / minus clinical research Close cross-functional collaboration, including with Biostatistics, Regulatory Affairs, Clinical Development, Medical Affairs, C&QA, Non-clinical drug safety, CMC Personal Skills: Fluent spoken and written professional English Excellent communication skills, oral and written – ability to present information clearly and concisely Strong team-working skills – working across cultural and functional boundaries Able to prioritise, adapt rapidly to changes in priorities, and manage multiple situations / issues, remaining calm and delivering under pressure Strategic thinking Problem-solving and decision-making ability Creative working in X-functional teams Open and appreciative corporate culture Multicultural environment Working in an attractive, high-quality equipped building with restaurant Free sports and language courses
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Clinical Development Scientist (f/m/d)

Do. 02.12.2021
Garching bei München
ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).Reporting to the Head of Clinical Development, in his / her position the Clinical Development Scientist (f/m/d) will help the Medical Leads in managing the scientific and medical activities of the different projects in close collaboration with external sub-contractors (CROs), internal and external experts as well as all ITM departments (Regulatory Affairs, Clinical Operations, R&D and Medical Affairs etc.). Support the project Medical Lead(s) Contribute from study strategy and design, protocol concept to data analysis, interpretation and final study report to deliver the clinical development activities which ensure consistency with the clinical development strategy Appropriately interact with Key Opinion Leaders (KOLs), collaborators, CROs, advisory boards, DSMB etc. Contribute to the medical monitoring and data cleaning of ongoing studies Ensure that high quality documents (protocols, IBs, ICFs etc.) are developed aligned to the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Participate in eCRF development Participates in data review ongoing through study including interim analyses, in-stream data review etc. Present the scientific rationale and study design at Investigator Meetings and respond to scientific questions arising from sites during study conduct Ensure prompt, quality communications with sites regarding protocol clarification and procedural queries Implement new business processes and strategies and also proactively identify issues and propose strategies to manage implications and risks on clinical study / Clinical Development plan Contribute to documents for regulatory submissions and advisory requirement, including scientific advice, IND / CTA, and NDA / BLA / MAA Contribute to all regulatory reporting requirements (e.g., DSUR, INDSRs etc.) Ensure prompt, quality responses to Regulatory Agencies, Institutional Review Boards (IRB) / Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC) etc. Deliver of end-of-study reports and publication/presentation of results Advanced life science degree (PhD, preferably MD) Ability to work in a hierarchically flat, matrix environment Ideally a minimum of one to two years of professional experience as clinical scientist in a drug / biologic developing company, ideally in oncology indication Strong working knowledge of the clinical drug development process, clinical trial design, medical monitoring, data management (including CDISC standards) and biostatistics Ability to understand, integrate, analyse and interpret clinical data Fluency in English Good management, interpersonal, communication, negotiation and problem-solving skills A modern workplace and exciting opportunities in an evolving and fast growing company Challenging and varied projects in interdisciplinary, multicultural and highly professional teams A collegial corporate culture and short communication channels Flexible working hours with an attractive salary package and diverse corporate benefits
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