Country Approval Asociate
hace 3 meses
**Work Schedule**
Other
**Environmental Conditions**
Office
Trial Activation Approval Specialist I
Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. - Coordinates, under guidance, with internal functional departments to ensure Consulta de detalles: Petición de puesto: R-01203605 Trial Activation Approval Specialist I 11:20 04/09/2023 Página 2 de 3 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 have contact with investigators for submission related activities. - May act as a key-contact at country level for either Ethical or Regulatory submission-related activities. - Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. - Assists in developing country specific Patient Information Sheet/Informed Consent form documents. - Assists with grant budgets(s) and payment schedules negotiations with sites. - Enters and maintains trial status information relating to SIA activities onto PPD, or client (where contracted) 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
hace 3 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable...
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Country Approval Associate
hace 7 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. - Coordinates, under...
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Principal Ctry Approval Spec
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - Prepares, reviews and coordinates local regulatory submissions and strategies (MoH, EC, approvals, viral safety dossiers, import license) in alignment with global submission strategy. - Technical expertise and coordination oversight for projects in collaboration with relevant...
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Site Activation Partner I
hace 2 meses
Desde casa, México Parexel A tiempo completoThe Site Activation Partner I (SAP I) 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 client standards. Responsibility within a country and may span over more...
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Fsp - Site Managment Coordinator
hace 6 meses
Desde casa, México IQVIA A tiempo completoJob Overview Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general...
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Site Activation Specialist
hace 6 meses
Desde casa, México IQVIA A tiempo completo**Job Overview** Under moderate supervision, 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 and sponsors;...
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Regulatory & Start Up Specialist I - Central Hub
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**Job Overview** Perform country-level tasks related to Site Activation (SA) activities at a global scope, ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and budgetary guidelines. This role may also involve maintenance activities. **Essential Functions**: - Serve as Single Point of...
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Regulatory & Start Up Specialist, Cfsp
hace 6 meses
Desde casa, México IQVIA A tiempo completoWe are looking for a **Regulatory & Start Up Specialist** to join our cFSP team in a Home Based role! **Location**: Argentina & México **What You´ll Do** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project...
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Regulatory Specialist 2, Fsp
hace 6 meses
Desde casa, México IQVIA A tiempo completo**Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Essential Functions** - Under general supervision,...
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Fsp - Regulatory and Start Up Specialist Mex
hace 6 meses
Desde casa, México IQVIA A tiempo completoWe are looking for a **Regulatory & Start Up Specialist** to join our FSP team in a Home Based role! **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary...
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Site Monitor
hace 6 meses
Desde casa, México Parexel A tiempo completoMexico, Remote **Job ID** R0000020557 **Category** Clinical Trials **ABOUT THIS ROLE**: Parexel FSP is hiring a Site Monitor to support the Mexico region. The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.Monitoring will be conducted in line with the Study...
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Ejecutivo de Ventas
hace 6 meses
Desde casa, México bright A tiempo completoWork with our **Commercial Sales team** and play a critical role in achieving Bright’s goals by aligning the **Commercial Sales team** with the company's priorities. You'll be responsible for **explaining to Business Owners and staff about energy generation, production, and efficiency and comparing our current model with the possibility of switching to...
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Sr Site Contract Spec
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...