Country Approval Specialist
Há 1 mês
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
Há 1 mês
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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Ctry Approval Spec
Há 4 horas
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health. Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving...
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Ctry Approval Spec
Há 22 horas
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiroOur team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...
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Temporary Logistics Specialist
Há 1 mês
Sao 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...
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Product Owner Specialist
Há 1 mês
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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Product Owner Specialist
4 semanas atrás
Sao Paulo, Brasil Santander Tempo inteiroProduct Owner Specialist Country: Brazil **WHAT YOU WILL BE DOING** Atuação como PO (Product Owner) nível especialista, em projetos do Canal Externo - Portal Parceiro Santander (Portal FVE). Para essa posição, buscamos um profissional com bastante senioridade, para acompanhar grandes projetos e com inteiração com diversas areas / niveis...
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Bra Cyber Security Specialist
Há 1 mês
Sao Paulo, Brasil Santander Tempo inteiroBRA Cyber Security Specialist Country: Brazil **WHAT YOU WILL BE DOING** Como 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...
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Product Owner Specialist
Há 1 mês
Sao Paulo, Brasil Santander Tempo inteiroProduct Owner Specialist - Open Finance Country: Brazil **WHAT YOU WILL BE DOING** **Requisitos Imprescindíveis** - Capacidade de interagir com os negócios, plataformas e tecnologia - Coordenação das demandas entre negócios, plataformas e TI de forma holística **Requisitos Desejáveis** - Desejável conhecimento de documentação de APIs...
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Clinical Research Head of Country Operations
4 semanas atrás
Sao Paulo, Brasil Alexion Pharmaceuticals,Inc. Tempo inteiroLocation: São Paulo, Brazil Job reference: R-191595 Date posted: 02/09/2024 AstraZeneca is one of the most fascinating biopharmaceutical companies in the world. From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend...
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Site Activation Specialist in Brazil
4 semanas atrás
Sao Paulo, Brasil IQVIA Tempo inteiroUnder moderate supervision, the **Site Activation Specialist **executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites...
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Commercial Finance Specialist
4 semanas atrás
Sao Paulo, Brasil Stryker Corporation Tempo inteiro**What We Want**: - ** Data managers.** People who enjoy compiling, organizing and consolidating large volumes of data and reports. - ** Data communicators.** Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. - ** Collaborative partners.** People who build and leverage...
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Category Specialist
4 semanas atrás
Sao Paulo, Brasil ABB Tempo inteiro**Category Specialist**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations. Together, we are...
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Site Activation Partner I
Há 3 dias
Sao Paulo, Brasil Pfizer Tempo inteiroJOB SUMMARY The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards. Responsibility within a country and may span over more...
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Associate Site Contract Specialist
Há 1 mês
Sao Paulo, Brasil Thermo Fisher Scientific Tempo inteiroDrafts, reviews, negotiates and finalizes amendments and budgets with study sites in accordance with local/accepted process. - Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with contractual considerations, client contractual considerations, established process with...
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IT Specialist
Há 1 mês
Sao Paulo, Brasil Santander Tempo inteiroIT Specialist Country: Brazil **WHAT YOU WILL BE DOING** **Perfil: Eng de Dados Esp. I** Responsabilidades e atribuições: - Liderança técnica de engenheiros de dados; - Formação de novos líderes técnicos; - Modernização de sistemas utilizando Big Data e conceitos Hadoop e Cloud; - Migração de ecossistema Big Data On Premisses para Cloud; -...
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Data & Analytics Specialist
4 semanas atrás
Sao Paulo, Brasil Santander Tempo inteiroData & Analytics Specialist Country: Brazil **WHAT YOU WILL BE DOING** Descrição: Responsável pela interface direta com as áreas de negócio, com objetivo de estruturar ações de CRM de acordo com os objetivos do negócio e a visão cliente. Em CRM Negócio definimos o público para campanhas de oferta e relacionamento, buscando maximizar o resultado...
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Poultry Specialist
Há 4 dias
Sao Paulo, Brasil HamdanGlobal Tempo inteiroOur team is hiring **Poultry Specialist** role for one of Leading firm based in one of **gorgeous country, Oman**. this position will **offer competitive salary + accommodation** **Position Summary**: **Reports to Veterinary and Livestock Supervisor.** To plan and organize poultry tasks and care as per Company Policy and instructions from Livestock Farm...
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Consumer Product Specialist
Há 1 mês
Sao Paulo, Brasil Gracemark Tempo inteiro**Consumer Product Specialist** - Location:* Alameda Xingu, 350 - Alphaville Industrial, Barueri - SP, 06455-911, Brazil - Pay Rate: R$16.000,00 / Monthly **About the Role**: Our client is dedicated to driving meaningful show awareness and engagement through consumer products and promotions. As a Consumer Product Specialist, you'll play a key role in...
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Consumer Product Specialist
Há 1 mês
Sao Paulo, Brasil Gracemark Tempo inteiro**Consumer Product Specialist** - Location:* Alameda Xingu, 350 - Alphaville Industrial, Barueri - SP, 06455-911, Brazil - Pay Rate: R$16.000,00 / Monthly **About the Role**: Our client is dedicated to driving meaningful show awareness and engagement through consumer products and promotions. As a Consumer Product Specialist, you'll play a key role in...
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Product Owner Specialist
Há 1 mês
Sao Paulo, Brasil Santander Tempo inteiroProduct Owner Specialist Country: Brazil **WHAT YOU WILL BE DOING** **As principais atividades**: - Alinhar o produto à estratégia da empresa; - Participar de forma ativa da estratégia e ter visão de longo prazo; - Medir constantemente o sucesso do produto; - Criar e comunicar os itens do Product Backlog; - Assegurar que o Product Backlog está...