Clinical Trial Reg Affairs Specialist Ii
hace 4 semanas
Prepares and reviews regulatory submissions
- Provides regulatory strategy as support RAL and RAL and/or technical advice to internal and external clients and acts as a liaison in executing strategies.
- Leads the development and implementation of project-specific processes for sponsors.
- Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
- Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
- Provides training and guidance to junior team members as appropriate.
- Participates in project launch meetings, review meetings and project team meetings.
- Supports business development activities, including project budgeting/forecasting.
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Director, Clinical Development Oncology
hace 4 semanas
Tlahuac, México Gilead Sciences A tiempo completoFor Current Gilead Employees and Contractors: At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight...
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Clinical Team Lead
hace 4 semanas
Tlahuac, México Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Clinical Aplication Specialist Medical Devices
hace 5 días
Tlahuac, México Recruiters and HR Advisors LATAM A tiempo completo**Vacante para la empresa Recruiters and HR Advisors LATAM en Benito Juárez, Ciudad de México**: **Clinical aplication specialist medical devices**: **Application specialist medical devices**: Empresa Trasnacional especialista en Medical Devices solicita: **3 VACANTES DE Clincal Specialist - Especialista de Producto Capacitador / Entrenador** Vacantes...
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Clinical Payments Associate
hace 6 días
Tlahuac, México ICON A tiempo completo**Overview**: Our client is looking for a Clinical Payment Associate to liaise across the CP&P team and with other departments such as local and global clinical teams and finance, to obtain necessary information required to configure the CTPS and resolve escalated issues. **Responsibilities**: Check vendor payee details across multiple systems for...
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Cra (Level Ii)
hace 4 semanas
Tlahuac, México Thermo Fisher Scientific A tiempo completoMonitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and...
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Clinical Specialist/ Neurovascular
hace 4 semanas
Tlahuac, México Medtronic A tiempo completo**Careers that Change Lives **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Conducts on-site education and / or consulting. - Supports field personnel in providing the best possible outcomes and service for Medtronic customers. - Partners with sales colleagues to develop and execute plans of sales for...
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Application Specialist
hace 4 semanas
Tlahuac, México Recruiters and HR Advisors LATAM A tiempo completo**Vacante para la empresa Recruiters and HR Advisors LATAM en Insurgentes Sur -Benito Juárez, Ciudad de México**: CLINICAL APPLICATION SPECIALIST - Capacitador. **3 VACANTES POR CRECIMIENTO INTERNO** Empresa Trasnacional especialista en Medical Devices solicita: **3 VACANTES DE Clincal Specialist - Especialista de Producto Capacitador /...
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Regulatory Affairs Specialist
hace 4 semanas
Tlahuac, México Edwards Lifesciences A tiempo completoMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...
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Site Manager/ Clinical Research
hace 6 días
Tlahuac, México Johnson & Johnson A tiempo completoEn Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad. La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y...
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Cra (Level I)
hace 4 semanas
Tlahuac, México Thermo Fisher Scientific A tiempo completoEssential Functions - Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable...
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Patient Safety Specialist
hace 4 semanas
Tlahuac, México SDZ MEX A tiempo completo2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers...
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Patient Safety Specialist
hace 4 semanas
Tlahuac, México SDZ MEX A tiempo completo2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers...
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Principal Professional, Quality Issue Management
hace 20 horas
Tlahuac, México Syneos - Clinical and Corporate - Prod A tiempo completo**Description** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything...
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Cra 1
hace 4 semanas
Tlahuac, México Novasyte A tiempo completoJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...
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16254-cra 2
hace 4 semanas
Tlahuac, México Novasyte A tiempo completoJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...
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Regulatory Affairs Associate Consultant
hace 20 horas
Tlahuac, México ClinChoice A tiempo completoAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice is searching for a **Regulatory Affairs Associate Consultant** to join one of our clients. **Main Job Tasks and Responsibilities**: -...
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Start-up & Regulatory Specialist
hace 4 semanas
Tlahuac, México Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Trial Resource Allocation Specialist
hace 2 días
Tlahuac, México Thermo Fisher Scientific A tiempo completoPlease add job description for Resource Analyst
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Rare Diseases Medical Educator
hace 1 hora
Tlahuac, México AstraZeneca A tiempo completo**RARE DISEASES MEDICAL EDUCATOR - NEUROLOGIST** **CDMX, MTY, GLD** - AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical...
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Trial Patient Payment Associate Ii
hace 4 semanas
Tlahuac, México Thermo Fisher Scientific A tiempo completo[10:06 AM] Paige Lewis **Summarized Purpose**: Provides administrative, reporting, contractual and financial support to the department related to the processing of payments to investigative sites. Responsibilities include data compilation, issue/risk resolution, and ensuring adherence to contractual guidelines and country regulations. **Essential Functions...