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Country Approval Specialist
Há 5 dias
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.Provides project specific local SIA services and coordination of these projects.May have contact with investigators for submission related activities.Key-contact at country level for either Ethical or Regulatory submission-related activities.Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.Achieves PPD’s target cycle times for site.May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.May develop country specific Patient Information Sheet/Informed Consent form documents.Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
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Country Approval Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPrepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. ...
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Country Approval Specialist
Há 2 dias
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPrepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal...
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Country Approval Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroProvides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. Provides project specific local SIA services and coordination of these projects. May have contact with investigators for submission related activities. Keycontact at country level for either Ethical or Regulatory submissionrelated activities. Coordinates, under...
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Country Approval Specialist
2 meses atrás
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPrepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal...
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Country Approval Specialist
2 meses atrás
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiroProvides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. - Provides project specific local SIA services and coordination of these projects. - May have contact with investigators for submission related activities. - Key-contact at country level for either Ethical or Regulatory submission-related activities. - Coordinates,...
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Trial Activation Approval Specialist Ii
2 semanas atrás
São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPPD, now Thermo Fisher's clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services.**At PPD, we are passionate, deliberate, and driven by our purpose- to improve health**We are vital links between an idea for a new medicine and the people...
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Trial Activation Approval Specialist Ii
2 semanas atrás
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiro**PPD, now Thermo Fisher’s clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services.** **At PPD, we are passionate, deliberate, and driven by our purpose - to improve health!** We are vital links between an idea for a new medicine and...
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Temporary Logistics Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Olin Tempo inteiroOlin Chlor Alkali Products and Vinyls, a division of Olin Corporation, is seeking a Temporary Logistics Specialist. This position will be located at the São Paulo, Brazil office. In your role as a Logistics/Quality Specialist you will develop and work with local carriers to ensure that customer orders in the region meet the requirements of the businesses in...
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Product Owner Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil Santander Tempo inteiroProduct Owner SpecialistCountry: BrazilWHAT YOU WILL BE DOING Requisitos Imprescindíveis: conhecimento do framework scrum; boa comunicação; experiência como Product Owner; Requisitos Desejáveis: experiência/contato prévio na área de CRM; Conhecimento dos conceitos de OKR e suas aplicações em gestão de produto; Atividades: Geração e controle de...
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Product Owner Specialist
4 semanas atrás
Sao Paulo, Brasil Santander Tempo inteiroProduct Owner Specialist Country: Brazil **WHAT YOU WILL BE DOING** - Requisitos Imprescindíveis: conhecimento do framework scrum; boa comunicação; experiência como Product Owner; - Requisitos Desejáveis: experiência/contato prévio na área de CRM; Conhecimento dos conceitos de OKR e suas aplicações em gestão de produto; - Atividades: Geração e...
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Country Manager
3 semanas atrás
São Paulo, São Paulo, Estado de São Paulo, Brasil MSN Laboratories Tempo inteiroIn this pivotal role, your primary responsibility will be to develop and execute a comprehensive country strategy and growth plan for MSN in Brazil. This will involve identifying market opportunities for both current and future products, managing local QC laboratory activities and facilitating dossier submissions, conducting market research, managing...
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Product Owner Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Santander Tempo inteiroProduct Owner SpecialistCountry: BrazilWHAT YOU WILL BE DOING-Requisitos ImprescindíveisPO para atuação em projetos da tesouraria, conhecimento de produto derivativos e renda fixa, experiência em execução de projetos com a tecnologia;-Requisitos DesejáveisExperiência nas rotinas de BackOffice de Derivativos e Renda Fixa;-AtividadesProduct Owner de...
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Product Owner Specialist
3 semanas atrás
Sao Paulo, Brasil Santander Tempo inteiroProduct Owner Specialist Country: Brazil **WHAT YOU WILL BE DOING** **-Requisitos Imprescindíveis** PO para atuação em projetos da tesouraria, conhecimento de produto derivativos e renda fixa, experiência em execução de projetos com a tecnologia; **-Requisitos Desejáveis** Experiência nas rotinas de BackOffice de Derivativos e Renda...
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IT J12 Specialist
Há 1 mês
Sao Paulo, Brasil Santander Tempo inteiroIT J12 Specialist Country: Brazil **WHAT YOU WILL BE DOING** Analista Middleware - Especialista Requisitos: Conhecimento e experiência em middleware: WAS, SOA, Weblogic, Jboss, TomCat, Openshif. Vivência em Sistemas Operacionais: Linux e Windows; Conhecimento em ITIL. Necessário: Conhecimentos Cloud / Openshift / Paas Atividades: Atuação em projetos...
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Country Manager
2 semanas atrás
São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiroIn this pivotal role, your primary responsibility will be to develop and execute a comprehensive country strategy and growth plan for MSN in Brazil. This will involve identifying market opportunities for both current and future products, managing local QC laboratory activities and facilitating dossier submissions, conducting market research, managing...
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Product Owner Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Santander Tempo inteiroProduct Owner SpecialistCountry: BrazilWHAT YOU WILL BE DOING-Requisitos ImprescindíveisPO para atuação em projetos da tesouraria, conhecimento de produto derivativos e renda fixa, experiência em execução de projetos com a tecnologia;-Requisitos DesejáveisExperiência nas rotinas de BackOffice de Derivativos e Renda Fixa;Conhecimento do sistema...
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IT J12 Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Santander Tempo inteiroIT J12 SpecialistCountry: BrazilWHAT YOU WILL BE DOINGAnalista Middleware - EspecialistaRequisitos: Conhecimento e experiência em middleware: WAS, SOA, Weblogic, Jboss, TomCat, Openshif.Vivência em Sistemas Operacionais: Linux e Windows;Conhecimento em ITIL.Necessário: Conhecimentos Cloud / Openshift / PaasAtividades: Atuação em projetos na área de TI...
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Bra Cyber Security Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Santander Tempo inteiroBRA Cyber Security SpecialistCountry: BrazilWHAT YOU WILL BE DOINGComo especialista do time de gestão de identidades e acessos, você será responsável pela execução e acompanhamento de projetos relacionados a integração de aplicações catalogadas para o nosso sistema central de gestão de acessos, garantindo a execução dos controles de gestão de...
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Country Manager
2 semanas atrás
São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiroIn this pivotal role, your primary responsibility will be to develop and execute a comprehensive country strategy and growth plan for MSN in Brazil. This will involve identifying market opportunities for both current and future products, managing local QC laboratory activities and facilitating dossier submissions, conducting market research, managing...
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Country Manager
2 semanas atrás
São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiroIn this pivotal role, your primary responsibility will be to develop and execute a comprehensive country strategy and growth plan for MSN in Brazil. This will involve identifying market opportunities for both current and future products, managing local QC laboratory activities and facilitating dossier submissions, conducting market research, managing...