Regulatory Writing Stellenangebote


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1.173 Stellenangebote


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Stellenangebot Regulatory Writing Job bei N26 GmbH Job gestern gefunden N26 GmbH

Associate- Financial Control and Reconciliation

• Berlin Homeoffice möglich
MEHR[...] management What you need to be successful: Background:University degree in Business, Economics, Computer Science or other technical background with relevant professional experience 3 to 5 years of professional experience in Finance, Risk or Data Management Skills: Good knowledge of the regulatory requirements for risk management as well as strong knowledge of the standard risk controlling methods and procedures, experience in the [...] In- depth knowledge of financial reporting, accounting, data warehousing Expertise as a user of standard statistical and data analysis software such as Python, SQL, Power BI, Tableau, R etc Analytical and conceptual skills, paired with eloquent communication in speech and writing as well as a high degree of organisational talent and initiative Fluent in English, German is a plus Accelerate your [...]
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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 [...]
Job vom 24.10.2024 Aesculap AG part of the B. Braun Group

Projektmanager (w/m/d) Klinische Bewertungen Klinische Studien

• Tuttlingen Abgeschlossenes Studium Flexible Arbeitszeiten Betriebliche Altersvorsorge
MEHR[...] führen klinische Bewertungen von Medizinprodukten (innerhalb der Kernindikation Orthopedic and Spinal Surgery) durch und erstellen die dazugehörige Dokumentation Sie übernehmen assoziierte Tätigkeiten wie zum Beispiel Review von Informationsmaterialien bezüglich klinischer Belange und nehmen an Risikoanalysen und Product- Safety- Cases teil Regulatory Educational Medical Writing: Die Recherche, Auswertung sowie Darstellung der wissenschaftlichen Literatur zu verschiedenen Themen und Anlässen liegt in Ihrer Hand Die Durchführung von [...]
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Stellenangebot Regulatory Writing Job bei Robert- Bosch- Krankenhaus GmbH Job gestern gefunden Robert- Bosch- Krankenhaus GmbH Doctoral Student/ Ph. D. Candidate (m/f/d) - Functional epigenomics in leukemia • Stuttgart 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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Stellenangebot Regulatory Writing Job bei Robert- Bosch- Krankenhaus GmbH Job gestern gefunden Robert- Bosch- Krankenhaus GmbH

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

• Esslingen 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 [...]
Stellenangebot Regulatory Writing Job bei Robert- Bosch- Krankenhaus GmbH Job gestern gefunden Robert- Bosch- Krankenhaus GmbH Doctoral Student/ Ph. D. Candidate (m/f/d) - Functional epigenomics in leukemia • Fellbach 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 [...]
Stellenangebot Regulatory Writing Job bei Robert- Bosch- Krankenhaus GmbH Job gestern gefunden Robert- Bosch- Krankenhaus GmbH Doctoral Student/ Ph. D. Candidate (m/f/d) - Functional epigenomics in leukemia • Ludwigsburg 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 [...]
Stellenangebot Regulatory Writing Job bei Robert- Bosch- Krankenhaus GmbH Job gestern gefunden Robert- Bosch- Krankenhaus GmbH Doctoral Student/ Ph. D. Candidate (m/f/d) - Functional epigenomics in leukemia • Korntal- Münchingen 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 [...]
Stellenangebot Regulatory Writing Job bei Robert- Bosch- Krankenhaus GmbH Job gestern 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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Neu Job vor 10 Std. gefunden knoell Senior Controller- Focus on Non Financial Reporting (f/m/d) Work-Life-Balance
MEHRSenior Controller- Focus on Non Financial Reporting (f/m/d) knoell is one of the leading global service providers in offering regulatory registration, clinical development and product development support to clients. Our team of scientific and regulatory experts and extensive network of [...] Controlling. MS Office applications, especially Excel and have application experience with ERP solutions (Microsoft Access is a plus) . You are able to communicate on a professional basis in English as well as in German. A very good understanding and writing in German is essential. You are able to lead having leadership skills (Project management and strong communication skills) . WHAT [...]
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Jobs aus mittelfrankenJOBS.de

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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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Job vor 5 Tagen gefunden Associate Director Engineering- Device Technology (m/f/d) • Schaftenau, Tirol Führungs-/ Leitungspositionen
MEHR[...] as well as LCM of commercial products. Write key design history file documents: design input requirements, global component specifications, and design verification documents. Ensure device design development is delivered to a high quality following the design control process and applicable regulatory framework. Ensure components are delivered and controlled to the required quality for clinical trials and commercial production. Support Regulatory Affairs [...] or PhD degree in engineering or equivalent. Preferably 8+ years of experience working in the development of medical devices and/ or combination products; preferably in the pharmaceutical area or similar. Experience of preparing for submissions and launch as well as writing design history files. Experience in developing plastic and metal components; tolerance analysis, modeling, and testing. Excellent skills in English, verbal [...]
Job vor 8 Tagen gefunden

Associate Director Engineering- Device Technology (m/f/d)

• Schaftenau, Tirol Führungs-/ Leitungspositionen
MEHR[...] as well as LCM of commercial products. Write key design history file documents: design input requirements, global component specifications and design verification documents. Ensure device design development is delivered to a high quality following the design control process and applicable regulatory framework. Ensure components are delivered and controlled to the required quality for clinical trials and commercial production. Support Regulatory Affairs [...] Bachelor, Master or PhD degree in engineering or equivalent. Preferably 8+ years of experience working in development of medical device and/ or combination products; preferred in pharmaceutical area or similar. Experience of preparing for submissions and launch as well as writing design history files. Experience in developing plastic and metal components; tolerance analysis, modeling and testing. Excellent skills in English, verbal [...]
Job vom 27.10.2024 Compliance Counsel (m/w/d) • München, Bayern Beratungs-/ Consultingtätigkeiten Work-Life-Balance
MEHR[...] enthusiasm, social competence and team player qualities Fluent in German and English Application Instructions In order to consider your application, we require your application to be submitted via our online applicant portal. In addition to uploading your CV, we recommend writing a cover letter to tell us more about why the position is of interest to you. About us As the [...]
Job vom 25.10.2024

Director, Regulatory Risk Management Forensic and Litigation Consulting

Führungs-/ Leitungspositionen Beratungs-/ Consultingtätigkeiten
MEHRDirector, Regulatory Risk Management Forensic and Litigation Consulting We are involved in complex, global and high- profile litigation, arbitration and investigations combining [...] of the leading professionals in the industry, FTI Consulting offers extensive internal and external training opportunities. Qualifications Experience Deep experience in AFC and Compliance topics. Proven track record in shaping and delivering financial crime consultancy assignments. High quality verbal and writing skills- able to translate complex matters into accessible language. We offer a competitive benefits and wellbeing programme including private medical [...]
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Job vom 15.10.2024 Pharmacovigilance Officer/ EU- QPPV (Reporting to the Chief Medical Officer) • Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen
MEHR[...] role of the Pharmacovigilance Officer is of the highest importance. Bringing broad knowledge to the drug safety function, you are embedded into Ai Curis project teams and support drug development related to all aspects of pharmacovigilance during discovery, drug development, regulatory review and approval. One of the long- term goals of this role is to extend the Ai Curis drug safety [...] system and establishing its system master file Ensuring adherence to the GVP modules as defined by the European Commission Continuous observation of the regulatory landscape and scientific literature regarding pharmacovigilance Reviewing and amending safety information within development documents Responsible for writing and reviewing adverse event narratives and periodic reports Responsible for standard operating procedures in pharmacovigilance, regular updates and training adherence [...]
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Job vom 11.10.2024

Lead Medical Writer (Reporting to Vice President Regulatory Affairs)

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen
MEHRYour mission As a Lead Medical Writer, you will plan, author, and organize the review process of documents pertaining to clinical studies and regulatory interactions, including (but not limited to) critical sections of marketing applications, protocols, clinical study reports, briefing documents, and responses to agency requests for information. In this role, you will need to apply critical thinking, scientific writing, data interpretation, and knowledge of regulatory content life- cycle. You will oversee and coordinate other external writers assisting on documents [...]
Job vom 26.09.2024 Director Medical Affairs C EE • Heidelberg, Baden- Württemberg Führungs-/ Leitungspositionen
MEHR[...] acceptance for a Regional Medical Affairs Strategic Plan. Addressing product or patient safety issues by intervening withHCPs and within BD processes. Providing training for commercial teams and other BD personnel. Supporting legislative, market access, and reimbursement efforts. Ensuring statistical analysis, writing, reporting, publishing and presenting of portfolio level evidence, including assisting/ collaborating with HCPs, as needed Supporting implementation of Medical Information, [...] MD (Preferred) , PhD (Life Sciences) , PharmD with optional MBA or equivalent experience in management. Leadership and people development skills. Strong organizational skills and the ability to work effectively in a dynamic environment. In- depth knowledge of clinical and regulatory requirements for a multi- layer medical organization. Ability to identify unmet clinical needs and evaluate product opportunities. Experience engaging with [...]
Job vom 17.07.2024

Global Investment Banking M A Associate (Industrials Consumer) , Frankfurt

• Frankfurt, Hesse
MEHR[...] Associates may be assigned specific departmental responsibilities, including in relation to business development activities. Key competencies and skills: Associates should have established the following: A thorough understanding of accounting practices and ability to undertake detailed financial analysis Financial modeling skills Writing skills Presentation skills (primarily in terms of preparation of presentations) Time and project management Associates should have established/ be establishing the following: Commercial judgment and awareness Transaction execution skills Presentation skills (both preparation and delivery) Negotiation skills People management (in particular the development of analysts and taking responsibility for their output) Client relationship skills Thorough regulatory and legal knowledge (ideally including the Listing Rules and the Blue Book) Stock Market and general economic awareness This position [...]
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