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Nonclinical Submission Manager
hace 2 semanas
Zauma Barcelona, España**Descripción**: · Como Nonclinical Submission Manager trabajarás con los científicos no clínicos de AstraZeneca y los colegas de regulación para gestionar la planificación, preparación y finalización de todas las contribuciones no clínicas, incluidos los conjuntos de datos SEND ...
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Nonclinical Submission Manager
hace 2 semanas
ICON Barcelona, EspañaPrepares/executes global/regional nonclinical regulatory submissions on allocated projects/products that implement the agreed regulatory strategy to develop and maintain products. Generates/project manages delivery, to time/quality of submissions. Demonstrates in depth knowledge ...
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Nonclinical Submission Manager
hace 2 semanas
AstraZeneca Barcelona, España**Nonclinical Submission Manager** · **Barcelona, Spain** · Make a more meaningful impact to patients' lives around the globe · Here you'll have the opportunity to make a meaningful difference to patients' lives. With science at its heart, this is the place where breakthroughs bo ...
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CTA Submission Manager
hace 2 semanas
Morgan Philips Executive Search Barcelona, España Temporary/ContractComo CTA Manager, brindará apoyo administrativo y operativo vital a nuestro equipo de investigación clínica para garantizar la realización exitosa de ensayos clínicos. Trabajará en estrecha colaboración con el personal clave del estudio, como investigadores, coordinadores de inve ...
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Iqvia Barcelona, EspañaThe Associate Director – Regulatory Submissions The Associate Director – Regulatory Submissions is responsible to lead a worldwide Regulatory Submissions delivery team within IQVIA Translations. This team is in charge of the development and harmonization of the Regulatory Submiss ...
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Manager, Orsse Labeling
hace 3 semanas
AstraZeneca Barcelona, EspañaAre you ready to take on a role that prepares and executes global/regional regulatory tactical submission plans on allocated projects/products? This role is designed for individuals who are ready to implement the agreed regulatory strategy to develop and maintain products. As a M ...
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Regulatory Affairs Manager, Vaccines
hace 2 semanas
AstraZeneca Barcelona, España**Job Title**:Regulatory Affairs Manager, Vaccines & Immune Therapies** · **Number of positions**: 3 · **Grade E** · **Location**:Barcelona, Spain · **Salary**: Competitive & Excellent Benefits Package · **Introduction to role** · Are you passionate about **science** and experien ...
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Regulatory Affairs Director
hace 3 semanas
Consult Search Barcelona, España**Scope**: · A fantastic opportunity has presented itself to join a globally renowned 'pure play' Aesthetic Company. Due to the rapid growth of this business, our client are seeking a high calibre Regulatory Affairs Director to join their team in Barcelona. This establishment has ...
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Director - Regulatory Affairs Medtech
hace 2 semanas
Alira Health Barcelona, EspañaJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be ac ...
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Regulatory Affairs Manager
hace 2 semanas
AstraZeneca Barcelona, EspañaAt AstraZeneca, we're not just about treating diseases - we're about defeating them. We're on a mission to turn innovative science into life-changing medicines, and we need your help. As a Reg Affairs Manager in our Oncology R&D department, you'll play a crucial role in gaining a ...
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Consultant, Regulatory Affairs Medtech
hace 2 semanas
Alira Health Barcelona, EspañaJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be ac ...
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Associate Director Project Manager
hace 3 semanas
AstraZeneca Barcelona, EspañaThe Associate Director Project Manager will be responsible for project management activities related to clinical regulatory submissions and for Clinical Pharmacology and Quantitative Pharmacology (CPQP) deliverables within the Clinical Pharmacology and Safety Science (CPSS) Depar ...
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International Cmc Regulatory Affairs Director
hace 2 semanas
AstraZeneca Barcelona, EspañaWelcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, working together to turn the impossible into reality. If you are action-oriented, confident in leadership, collaborative, and curious about the ...
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International Cmc Regulatory Affairs Director
hace 1 semana
AstraZeneca Barcelona, España**About AstraZeneca** · At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to co ...
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Project Manager
hace 1 semana
AstraZeneca Barcelona, EspañaThe Project Manager will be responsible to provide support to regulatory submissions and Bioanalysis in Clinical and Quantitative Pharmacology (CPQP) within Clinical Pharmacology and Safety Science (CPSS) department. Pharmacology. · **Major Duties and Responsibilities** · - **Sub ...
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Financial Controller, Spain
hace 3 semanas
Instron Barcelona, España**Company Description** · Responsible for the full range of accounting and office management activities for Instron Spain. This will include the preparation of accounts under Spanish GAAP for this division and assistance with the local tax and statutory requirements for the legal ...
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Director, Statistics
hace 2 semanas
AstraZeneca Barcelona, España**Job Description / Capsule** · The Director, Statistics has sufficient experience in the pharmaceutical industry to independently lead a biometrics team to deliver project and/or technical level activities related to design, delivery and interpretation, high level internal gover ...
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Senior Director
hace 2 semanas
AstraZeneca Barcelona, EspañaWe continue to expand our regulatory teams at AstraZeneca's dynamic R&D sites in **Macclesfield (UK), Gaithersburg and Durham (US),** **Gothenburg (Sweden)** or **Barcelona (Spain).** · This role seeks a Regulatory Affairs professional with extensive experience in providing strat ...
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Associate Director, Clinical Regulatory Writing
hace 1 semana
AstraZeneca Barcelona, EspañaThe Vaccine & Immune Therapies (V&I) unit has been created with the ambition to develop and deliver vaccines and antibodies that transform our ability to prevent and treat infectious disease. The creation and growth of this unit reflects AstraZeneca's strong dedication to advance ...
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Sr. Regulatory Affairs
hace 2 semanas
Cmed Barcelona, EspañaThe Aixial Group is seeking a Sr. Regulatory Lead for this client dedicated opportunity with 8 years of experience in Regulatory Affairs. Remote based in Spain or Portugal. · Contribute to the development of the regulatory strategy for the respective portfolio, working collaborat ...
Cta Submission Manager - Barcelona, España - Morgan Philips Group Sa
Descripción
Como CTA Manager, brindará apoyo administrativo y operativo vital a nuestro equipo de investigación clínica para garantizar la realización exitosa de ensayos clínicos.
Trabajará en estrecha colaboración con el personal clave del estudio, como investigadores, coordinadores de investigación clínica y gerentes de proyectos, para garantizar el cumplimiento de las regulaciones y la precisión de los datos del ensayo.
Responsabilidades Recopilar, registrar y archivar información y documentos relacionados con el ensayo clínico de acuerdo con las Buenas Prácticas Clínicas (BPC).
Apoyar en la preparación y mantenimiento de documentos del estudio, incluyendo protocolos, formularios de consentimiento informado, formularios de reporte de caso y presentaciones regulatorias.
Coordinar reuniones de estudio y visitas a centros de investigación. Comunicación fluida con centros de investigación y proveedores del ensayo. Gestionar y procesar datos del ensayo clínico. Garantizar el cumplimiento de las normativas y las GCP. Brindar apoyo administrativo general al equipo de investigación clínica. Requisitos Deseable formación universitaria. Mínimo de 4 año de experiencia administrativa en investigación clínica. Experiencia en submission. Excelente organización, atención al detalle y habilidades multitarea. Fuertes habilidades de comunicación escrita y verbal. Capacidad para trabajar de forma independiente y como parte de un equipo. Experiencia en TMF Software de oficina (Word, Excel, PowerPoint) a nivel usuario. #J-18808-Ljbffr