Empleos actuales relacionados con FSP - Regulatory and Start Up Specialist MEX - Ciudad de México, Ciudad de México - IQVIA Argentina
-
Regulatory and Start-Up Specialist
hace 2 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewWe are seeking a highly skilled Regulatory and Start-Up Specialist to join our team at IQVIA. As a key member of our FSP team, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs),...
-
Regulatory and Start-Up Specialist
hace 2 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewWe are seeking a highly skilled Regulatory and Start-Up Specialist to join our team at IQVIA in a Home-Based role.Key ResponsibilitiesAct as the Single Point of Contact (SPOC) for investigative sites, ensuring seamless communication and coordination with the Site Activation Manager (SAM), Project Management team, and other departments.Ensure...
-
Regulatory Specialist
hace 6 días
Ciudad de México, Ciudad de México IQVIA A tiempo completoRegulatory and Start Up SpecialistWe are seeking a highly skilled Regulatory and Start Up Specialist to join our team in Mexico. As a key member of our FSP team, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard...
-
Regulatory Compliance Specialist
hace 6 días
Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completoJob OverviewMEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to join our team. As a key member of our clinical development team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the assigned countries.Key...
-
Regulatory and Start-Up Expert
hace 1 semana
Ciudad de México, Ciudad de México IQVIA Argentina A tiempo completoRegulatory and Start-Up ExpertJoin IQVIA Argentina as a Regulatory and Start-Up Expert and take on a challenging role in site management. As a key member of our team, you will be responsible for participating in end-to-end site management from feasibility to site closure. Your primary focus will be on serving as a point of contact for investigative sites and...
-
Country Start Up Specialist
hace 7 días
Ciudad de México, Ciudad de México Medpace, Inc. A tiempo completoJob OpportunityMedpace, Inc. is seeking a highly organized and detail-oriented Regulatory Submissions Coordinator to support our team in Mexico. As a key member of our Regulatory Submissions department, you will play a vital role in ensuring the timely and accurate submission of regulatory documents.Key ResponsibilitiesProvide administrative support for...
-
Study Start Up Manager
hace 2 semanas
Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Submissions Manager to join our Study Start Up team in Mexico City. This role plays a critical part in the clinical trial management process at Medpace.Key ResponsibilitiesManage and execute all aspects of global start-up efficiently;Perform quality checks on submission documents and site essential...
-
Country Start Up Specialist
hace 7 días
Ciudad de México, Ciudad de México Medpace, Inc. A tiempo completoJob OpportunityMedpace, Inc. is seeking a highly organized and detail-oriented Regulatory Submissions Coordinator to support our team in Mexico. As a key member of our Regulatory Submissions department, you will play a vital role in ensuring the timely submission of regulatory documents and providing exceptional support to our projects.Key...
-
Regulatory Specialist
hace 2 semanas
Ciudad de México, Ciudad de México Fortrea A tiempo completoJob Overview:As a leading global contract research organization (CRO), Fortrea is seeking a highly skilled Regulatory Specialist to join our team. With a passion for scientific rigor and decades of clinical development experience, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access,...
-
Country Start Up Specialist
hace 2 semanas
Ciudad de México, Ciudad de México Medpace, Inc. A tiempo completoJob SummaryMedpace, Inc. is seeking a highly skilled Regulatory Submissions Coordinator to join our team in Mexico. As a key member of our Regulatory Submissions department, you will have the opportunity to work on various projects, gaining valuable experience and developing your skills.Key ResponsibilitiesProvide daily support to the department and...
-
Regulatory Compliance Specialist
hace 2 semanas
Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completoJob SummaryMEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to join our team. As a key member of our clinical development team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the assigned countries.Key...
-
Regulatory Specialist for Clinical Research
hace 7 días
Ciudad de México, Ciudad de México IQVIA A tiempo completoRegulatory & Start Up SpecialistWe are seeking a highly skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role.Key Responsibilities:Perform country-level tasks associated with Site Activation (SA) activities in accordance with local and international regulations, SOPs, project requirements, and contractual guidelines.Act as the...
-
Regulatory Specialist for Site Activation
hace 7 días
Ciudad de México, Ciudad de México IQVIA A tiempo completo{"Job Overview": "We are seeking a highly skilled Regulatory Specialist to support our FSP team in a Home Based role. As a key member of our team, you will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures...
-
Country Start Up Specialist
hace 2 semanas
Ciudad de México, Ciudad de México Medpace, Inc. A tiempo completoJob Summary:We are seeking a highly organized and detail-oriented Regulatory Submissions Coordinator to join our team at Medpace, Inc. As a key member of our Regulatory Submissions department, you will play a vital role in supporting the preparation and submission of regulatory documents to competent authorities.Key Responsibilities:Provide day-to-day...
-
Regulatory Affairs Expert
hace 7 días
Ciudad de México, Ciudad de México 520 ICR Mexico - MEX A tiempo completoSenior Regulatory Affairs SpecialistAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at 520 ICR Mexico - MEX. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.Key...
-
Regulatory and Start-Up Specialist
hace 6 días
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewThis position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members.Key ResponsibilitiesParticipate in the development of in-house model process documents.Act as a primary site contact for end-to-end study activity,...
-
Area Study Start Up Lead
hace 7 días
Ciudad de México, Ciudad de México AbbVie A tiempo completoJob SummaryThe Area Study Start Up Lead is responsible for the on-time, budget, and quality delivery and execution of start-up and maintenance activities for assigned pipeline and Global Medical Affairs clinical studies within the area. This role reports to the Area SSU Head and serves as a single point of accountability for site start-up and maintenance...
-
Regulatory Compliance Specialist
hace 2 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at IQVIA in a Home-Based role. The successful candidate will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures...
-
Area Study Start Up Lead
hace 2 semanas
Ciudad de México, Ciudad de México AbbVie A tiempo completoAbout AbbVieAbbVie is a leading biopharmaceutical company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. Our mission is to make a remarkable impact on people's lives across various therapeutic areas, including immunology, oncology, neuroscience, and eye care.Job DescriptionThe Area Study Start...
-
Regulatory Submissions Manager
hace 2 semanas
Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Submissions Manager to join our Study Start Up team at the National Museum of Wildlife Art. This is a full-time, office-based position that plays a key role in the clinical trial management process.Key ResponsibilitiesEfficiently manage and successfully execute all aspects of global start-up;Perform...
FSP - Regulatory and Start Up Specialist MEX
hace 3 meses
We 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 guidelines. May also include maintenance activities.
Essential Functions
• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.
Qualifications
• Bachelor Degree in life sciences.
• +3 years of clinical research experience within regulatory area: submissions, knowledge of ICF, presentations to ethics committee, COFEPRIS.
• Fluent English: written and oral communication skills
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
#J-18808-Ljbffr
