Country Approval Specialist
8 meses atrás
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
8 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
4 meses atrás
São Paulo, SP, Brasil Thermo Fisher Scientific Tempo inteiro**Work Schedule** Other **Environmental Conditions** Office - 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...
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Ctry Approval Spec
4 meses atrás
São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroPosition Overview: As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding...
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Ctry Approval Spec
4 meses atrás
São Paulo, SP, Brasil Thermo Fisher Scientific Tempo inteiro**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Position Overview**: As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites. You have a strong attention to detail,...
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Site Activation Manager
4 semanas atrás
São Paulo, São Paulo, Brasil Catho Online Ltda. - Br - Specialist Tempo inteiroJob OverviewCatho Online Ltda. - Br - Specialist is seeking a skilled Site Activation Manager to join our team. In this role, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with local and international regulations.About the RoleAs a Site Activation Manager, you will serve as the...
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Vaga de Marketing Specialist
Há 1 mês
São Paulo, Brasil Catho Online Ltda. - BR - Specialist Tempo inteiroMarketing Specialist - VIE ContractLocation: Brazil, São Paulo Target start date: 01/03/2025 iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.PLEASE NOTE: Since this program is primarily an international development program, candidates cannot apply to a VIE...
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Latam Risk Specialist
4 semanas atrás
São Paulo, Brasil Django Rest Framework Tempo inteiroWise is hiring aRemote LATAM Risk SpecialistWise is looking for a capable and enthusiastic LATAM Risk Specialist to join our team in São Paulo. The LATAM Risk Specialist will report directly to the country CRO, providing support and second line risk management advice and oversight to the specific entity and other countries in the Latin America region.Wise...
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Site Activation Partner I
6 meses atrás
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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Commercial Finance Specialist
6 meses 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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Site Activation Specialist in Brazil
6 meses 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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Data & Analytics Specialist Iii
6 meses atrás
Sao Paulo, Brasil Santander Tempo inteiroData & Analytics Specialist III Country: Brazil **WHAT YOU WILL BE DOING** - Desenvolvimento de novas metodologias analíticas. Desenvolvimento de segmentações e agrupamento de clientes. Desenvolvimento de indicadores que auxiliem na tomada de decisão pelo negócio. Garantir automação dos processos analíticos e modelos. Garantir qualidade dos...
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Category Specialist
8 meses 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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Credit Analysis And Approval Specialist
2 meses atrás
São Paulo, Brasil Rabobank Gruppe Tempo inteiroThe Risk Officer (RO) function within Rural is an independent pro-active senior risk management role within the second line of responsibility with the aim to facilitate, monitor, challenge and support the business in realizing its strategic ambition to grow the Rural portfolio, including delegated approval authority.The RO operates within a robust risk...
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Clinical Operations Manager
7 meses atrás
Sao Paulo, Brasil MSD Tempo inteiroThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...
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Site Activation Specialist in Brazil
7 meses 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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Category Specialist
8 meses 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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Associate Site Contract Specialist
8 meses atrás
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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Poultry Specialist
6 meses atrás
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
6 meses atrás
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
6 meses atrás
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...