Regulatory Writing Stellenangebote


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Technik & Ingenieurwesen Technische Dokumentation / Redaktion


272 Stellenangebote


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Job vom 24.10.2024 Takeda GmbH

Process Engineer Drug Product (f/m/d)

 • Singen
MEHR[...] advanced technologies and process harmonization, while providing technical leadership for resolving product line issues and major projects. Serve as the primary technical interface between Technical Operations and drug product manufacturing sites, ensuring support for troubleshooting, Change Controls, investigations, CAPAs, and regulatory inspections. Collaborate with Development and Site Operations teams for technology transfers, risk assessments, and innovative solutions. Support the engineering, qualification, [...] use systems, aseptic filling, lyophilization, and visual inspection. Strong collaboration skills in a matrix environment, with internal teams and external partners. Flexibility to manage diverse projects, from complex topics to administrative tasks. Knowledge of regulatory processes, technology transfer, and technical writing is an advantage. Willingness to travel and excellent communication skills in English; German knowledge is a plus. Your benefits: Attractive [...]
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Stellenangebot Regulatory Writing Job bei Oxford Global Resources Job vor 3 Tagen gefunden Oxford Global Resources Freelance CRA- Medical Devices (German/ English) • Frankfurt Freiberuflich
MEHR[...] Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP) , and applicable regulations are followed. Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. May conduct on- site and remote site qualification, site initiation, interim, and site close- out monitoring visits. Serve as [...] study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. Attends internal and external meetings as required. Provides all job- related progress reports and visit documentation as required. May support safety activities such as narrative writing, managing the CEC/ DSMB, etc. Prepares and coordinates submissions to regulatory authorities. May perform other activities as assigned. Requirements Higher [...]
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Stellenangebot Regulatory Writing Job bei Robert- Bosch- Krankenhaus GmbH Job vor 9 Tagen gefunden Robert- Bosch- Krankenhaus GmbH

Doctoral Student/ Ph. D. Candidate (m/f/d) - Functional epigenomics in leukemia

 • Gerlingen Werkstudenten
MEHR[...] (RBK) . As an integral part of the National Center for Tumor Diseases (NCT) South West and the Comprehensive Cancer Center Tübingen- Stuttgart, RBCT is exclusively dedicated to innovative cancer research and treatment. Our group focuses on unraveling complex gene regulatory networks that govern the pathogenesis of hematological malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) . We employ [...] engaging in cancer research and awareness of the translational significance of research work Capability of working independently as well as good spirit of team working Openness to personal growth and ongoing learning initiatives Competence in interpersonal communication, presentation, and scientific writing Proficient English skills for both oral and written communication for academic information exchange Additional Information RBCT provides excellent research facilities [...]
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Job vom 22.08.2024 Phyto Lab GmbH Co. KG Wissenschaftlicher Mitarbeiter (m/w/d) Regulatory Affairs • 91487, Vestenbergsgreuth, Deutschland Betriebliche Altersvorsorge 30+ Urlaubstage Vermögenswirksame Leistungen
MEHR[...] sichern wir die Qualität pflanzlicher Produkte. Für uns sind Kollegialität und Nachhaltigkeit nicht nur Schlagworte, sondern die Wurzeln unseres Handelns. Gemeinsam erforschen wir die vielfältige Pflanzenwelt. Gestalten Sie mit uns die pflanzliche Zukunft und wachsen Sie als: Wissenschaftlicher Mitarbeiter (m/w/d) Regulatory Affairs ABWECHSLUNGSREICHE MISCHUNG IHR AUFGABENGEBIET Als Wissenschaftlicher Mitarbeiter (m/w/d) Regulatory Affairs unterstützen Sie das Team mit Ihrer verantwortungsbewussten und strukturierten Arbeitsweise. Hierbei fallen die folgenden Tätigkeiten in Ihr Aufgabengebiet: Erstellen von Zulassungsdossiers (CMC writing, Module 2. 3 und 3) für pflanzliche Arzneimittel in nationalen und europäischen Zulassungsverfahren Koordinieren aller Aktivitäten zur Neueinreichung von Zulassungsanträgen, [...]
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Stellenangebot Regulatory Writing Job bei PAUL HARTMANN AG Neu Job vor 7 Std. gefunden PAUL HARTMANN AG

Regulatory Affairs Manager for Clinical Evaluation (f/m/d)

 • Heidenheim
MEHR[...] you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as DEU- Heidenheim At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d) , we offer you a varied and challenging position in an international environment. Here, you can develop [...] an equivalent qualification Professional experience in the medical device environment or another regulatory field of work Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs Experience in literature search and review required as well as knowledge of regulatory medical writing Knowledge of database management Open and competent attitude when working with your stakeholders IT affinity and proficiency with the MS [...]
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Stellenangebot Regulatory Writing Job bei PAUL HARTMANN AG Neu Job vor 7 Std. gefunden PAUL HARTMANN AG Natural Scientist as Clinical Evaluation Manager (f/m/d) • Heidenheim
MEHR[...] you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as DEU- Heidenheim At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d) , we offer you a varied and challenging position in an international environment. Here, you can develop [...] an equivalent qualification Professional experience in the medical device environment or another regulatory field of work Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs Experience in literature search and review required as well as knowledge of regulatory medical writing Knowledge of database management Open and competent attitude when working with your stakeholders IT affinity and proficiency with the MS [...]
Stellenangebot Regulatory Writing Job bei PAUL HARTMANN AG Neu Job vor 7 Std. gefunden PAUL HARTMANN AG

Clinical Research Manager for Regulatory Affairs (f/m/d)

 • Heidenheim
MEHR[...] you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as DEU- Heidenheim At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d) , we offer you a varied and challenging position in an international environment. Here, you can develop [...] an equivalent qualification Professional experience in the medical device environment or another regulatory field of work Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs Experience in literature search and review required as well as knowledge of regulatory medical writing Knowledge of database management Open and competent attitude when working with your stakeholders IT affinity and proficiency with the MS [...]
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Stellenangebot Regulatory Writing Job bei PAUL HARTMANN AG Neu Job vor 7 Std. gefunden PAUL HARTMANN AG Regulatory Affairs Manager for Post- Market Surveillance (f/m/d) • Heidenheim
MEHR[...] you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as DEU- Heidenheim At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d) , we offer you a varied and challenging position in an international environment. Here, you can develop [...] an equivalent qualification Professional experience in the medical device environment or another regulatory field of work Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs Experience in literature search and review required as well as knowledge of regulatory medical writing Knowledge of database management Open and competent attitude when working with your stakeholders IT affinity and proficiency with the MS [...]
Stellenangebot Regulatory Writing Job bei PAUL HARTMANN AG Neu Job vor 7 Std. gefunden PAUL HARTMANN AG

Clinical Evaluation Manager (f/m/d)

 • Heidenheim
MEHR[...] you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as DEU- Heidenheim At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d) , we offer you a varied and challenging position in an international environment. Here, you can develop [...] an equivalent qualification Professional experience in the medical device environment or another regulatory field of work Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs Experience in literature search and review required as well as knowledge of regulatory medical writing Knowledge of database management Open and competent attitude when working with your stakeholders IT affinity and proficiency with the MS [...]
Stellenangebot Regulatory Writing Job bei PAUL HARTMANN AG Neu Job vor 7 Std. gefunden PAUL HARTMANN AG Life Scientist as Clinical Evaluation Manager (f/m/d) • Heidenheim
MEHR[...] you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as DEU- Heidenheim At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d) , we offer you a varied and challenging position in an international environment. Here, you can develop [...] an equivalent qualification Professional experience in the medical device environment or another regulatory field of work Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs Experience in literature search and review required as well as knowledge of regulatory medical writing Knowledge of database management Open and competent attitude when working with your stakeholders IT affinity and proficiency with the MS [...]
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Stellenangebot Regulatory Writing Job bei PAUL HARTMANN AG Neu Job vor 7 Std. gefunden PAUL HARTMANN AG

Regulatory Affairs Manager (f/m/d)

 • Heidenheim
MEHR[...] you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as DEU- Heidenheim At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d) , we offer you a varied and challenging position in an international environment. Here, you can develop [...] an equivalent qualification Professional experience in the medical device environment or another regulatory field of work Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs Experience in literature search and review required as well as knowledge of regulatory medical writing Knowledge of database management Open and competent attitude when working with your stakeholders IT affinity and proficiency with the MS [...]
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Jobbörse Stellenangebote Regulatory Writing Jobs gefunden bei Jobbörse Jobware

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Stellenangebot Regulatory Writing Job bei Robert- Bosch- Krankenhaus GmbH Job vor 11 Tagen gefunden Robert- Bosch- Krankenhaus GmbH Doctoral Student/ Ph. D. Candidate (m/f/d) - Functional epigenomics in leukemia Werkstudenten
MEHR[...] (RBK) . As an integral part of the National Center for Tumor Diseases (NCT) South West and the Comprehensive Cancer Center Tübingen- Stuttgart, RBCT is exclusively dedicated to innovative cancer research and treatment. Our group focuses on unraveling complex gene regulatory networks that govern the pathogenesis of hematological malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) . We employ [...] engaging in cancer research and awareness of the translational significance of research work Capability of working independently as well as good spirit of team working Openness to personal growth and ongoing learning initiatives Competence in interpersonal communication, presentation, and scientific writing Proficient English skills for both oral and written communication for academic information exchange Additional Information RBCT provides excellent research facilities [...]
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