- 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
há 1 semana
Thermo Fisher Scientific Sao Paulo, BrasilProvides, 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 ...
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Accounts Payable Specialist
há 3 dias
GP Strategies Corporation Sao Paulo, Brasil**Accounts Payable Specialist (Especialista de Conta a Pagar - temporário/licença maternidade)** · GP Strategies Corporation is a global performance improvement solutions provider of training, eLearning solutions, management consulting and engineering services. GP Strategies' sol ...
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Compliance Specialist
há 1 semana
Johnson & Johnson Sao Paulo, BrasilAt Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. · Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the h ...
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Warranty Specialist
há 1 semana
Porsche Brasil Sao Paulo, BrasilIf you make hearts beat faster, your own has to be in the right place. · **Warranty Specialist (M/F/d)**: · - **Code number**:J · - **Entry level**:Professionals · - **Location**:Sao Paulo · - **Organization**:Porsche Brasil · **Tasks · **Tasks**Tasks*** · The Warranty Specialis ...
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Itcr Specialist
há 1 dia
Nestle Sao Paulo, BrasilResumo da Posição: · - Localização: São Paulo, Brazil · - Área / BU: Information Technology · - Reporte: IT Operations Manager - Workforce 360 · - Alguma pessoa interna mapeada? Sim · - Position summary · - To strengthen Workforce 360 IT Service Management, we are looking for an ...
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Contract Specialist
há 1 semana
Medpace, Inc. Sao Paulo, BrasilJob Summary: · Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, Contract Specialist to join our LatAm Site Contract Team within the Clinical Operations team. This position will report to the LatAm Senior Contract Manager and will p ...
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Das Immunology
há 4 dias
Bristol-Myers Squibb Sao Paulo, Brasil**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
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Site Activation Specialist in Brazil
há 4 dias
IQVIA Sao Paulo, BrasilUnder 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 s ...
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Project Management Specialist Brand Solutions
há 1 semana
WarnerMedia Sao Paulo, Brasil**_Every great story has a new beginning, and yours starts here._** · **_ Welcome to Warner Bros. Discoverythe stuff dreams are made of._** · **Who We Are ** · When we say, "the stuff dreams are made of," we're not just referring to the world of wizards, dragons and superheroes, ...
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Pl Product Manager
há 3 dias
Alexion Pharmaceuticals,Inc. Sao Paulo, BrasilAlexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris (eculizumab) and Ultomiris (ravulizumab) approved complement inhibitor to ...
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Finance Administrator/specialist
há 3 dias
Zhejiang Dingli Machinery Co., Ltd. Sao Paulo, Brasil**About Dingli**: · Dingli is an industry leading manufacture of Elevating Work Platforms (EWP) head quartered in Hangzhou, China and are listed on the Shanghai Stock Exchange (SSE). With a commitment to innovation and cutting-edge technology, Dingli has established itself as one ...
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Sr Cra
há 6 dias
Thermo Fisher Scientific Sao Paulo, BrasilPerforms and coordinates all aspects of the clinical monitoring and site management process. Conducts · remote or on-site visits to assess protocol and regulatory compliance and manages required · documentation. Manages procedures and guidelines from different sponsors and/or mon ...
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Gss Legal and Compliance Specialist
há 1 semana
NOKIA Sao Paulo, Brasil**Come create the technology that helps the world act together** · Nokia is committed to innovation and technology leadership across mobile, fixed and cloud networks. Your career here will have a positive impact on people's lives and will help us build the capabilities needed for ...
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Hccp Lead Specialist
há 1 semana
Johnson & Johnson Sao Paulo, BrasilAt Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. · Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the h ...
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Network Development Specialist
há 4 dias
Porsche Brasil Sao Paulo, BrasilIf you make hearts beat faster, your own has to be in the right place. · **Network Development Specialist**: · - **Code number**:J · - **Entry level**:Professionals · - **Location**:Sao Paulo · - **Organization**:Porsche Brasil · **Tasks · **Tasks**Tasks*** · We are looking for ...
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Purchasing Specialist
há 10 horas
Goldwind Sao Paulo, BrasilGoldWind Brazil has an opportunity for Purchasing Specialist, with the mission of managing the processes of purchasing transportation services, and assembly of components, acting in the support of commercial strategy and market analysis, with the objective of ensuring compliance ...
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PMO Specialist
há 1 semana
Vestas Sao Paulo, BrasilAs PMO Specialist you will: · - Lead the implementation of the portfolio of strategic initiatives defined for the Service LATAM team. · - Manage the project team, tracking the project execution to ensure high-quality deliverables. · - Communicate with internal and external stakeh ...
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Latam Retail Marketing Intern
há 10 horas
INTEL Sao Paulo, BrasilAt Intel we create world-changing technology that improves the life of every person on the planet. Our culture is centered on our values: · - We are bold and innovative, we create a space where everyone can contribute to their fullest potential and deliver their best work, our cu ...
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IT Support Specialist
há 4 dias
Overhaul Sao Paulo, Brasil**WHO WE ARE** · Overhaul is a supply chain integrity solutions company that allows shippers to connect disparate sources of data into the first fully transparent situational analysis engine designed for the logistics industry. Data that is transformed into critical insights can ...
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Sen. Credit Specialist
há 1 semana
Credit Suisse Sao Paulo, BrasilRisk Management · English · **We Offer** · Senior Credit Specialist #230629 · São Paulo - Brazil| Full-time | Credit Risk Management · **Your field of responsibility** · You will perform high-quality evaluation and risk assessment of new credit proposals and team up with the firs ...
Country Approval Specialist - São Paulo, Brasil - Thermo Fisher Scientific
Descrição
Usuários da profissão Country Approval Specialist em São Paulo
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Georgia Sanches
General Manager and Revenue Director