Regulatory and Start-Up Specialist
hace 2 meses
Job Overview
This 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 Responsibilities
- Participate in the development of in-house model process documents.
- Act as a primary site contact for end-to-end study activity, ensuring seamless communication with cross-functional teams.
- Provide detailed updates related to study and site activity during study team meetings.
- Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
- Oversee essential document collection, tracking, and review.
- Support the collection of country and site-level intelligence.
- Support Ethics Committee and Regulatory Authority submissions.
- Where required, complete, manage, and/or support country and site-specific activities required to activate or maintain sites for a study.
Requirements
- Bachelor's Degree in Business Administration, Finance, Science, or related field or work experience equivalent.
- Minimum of three years of relevant experience in the biopharmaceutical/CRO industry, including experience in EC submission in the US.
- Fluent English: written and oral communication skills.
- Proficiency with Veeva Vault and all applications of Microsoft Office.
- Ability to negotiate complex contract and payment terms.
- Goal-oriented, self-starter with proven ability to work independently.
- Able to proactively identify issues and provide potential solutions for resolution.
- Detail-oriented.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Good interpersonal skills.
About IQVIA
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.
-
Regulatory and Start-Up Expert
hace 11 horas
Ciudad de México, Ciudad de México IQVIA A tiempo completoRegulatory & Start Up SpecialistWe are seeking a skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role.Location: Argentina & MéxicoJob Summary:We are looking for a detail-oriented and organized Regulatory & Start Up Specialist to perform site activation activities in accordance with local and international regulations, standard...
-
Regulatory and Start-Up Specialist
hace 3 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),...
-
FSP Regulatory and Start-Up Specialist
hace 4 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob Title: FSP Regulatory and Start-Up SpecialistJob Overview:We are seeking a highly skilled Regulatory and Start-Up Specialist to join 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...
-
Regulatory and Start-Up Specialist 2, cFSP
hace 3 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoSite Management Specialist, Regulatory and Start-UpLocation: RemoteJob 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. This includes supporting site qualification, site level regulatory green light and...
-
Regulatory Specialist
hace 1 mes
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.Location: Argentina & MéxicoKey Responsibilities:Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating...
-
Regulatory Specialist
hace 1 mes
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 Specialist
hace 2 meses
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 and Compliance Specialist MEX
hace 1 semana
Ciudad de México, Ciudad de México IQVIA A tiempo completoWe are looking for a highly skilled Regulatory and Compliance Specialist to join our team in a Home Based role. This role will focus on 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), project requirements, and...
-
Regulatory Compliance Specialist
hace 3 semanas
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 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 Responsibilities:Maintain awareness of...
-
Study Start Up Associate II
hace 4 semanas
Ciudad de México, Ciudad de México Icon A tiempo completoJob SummaryWe are seeking a highly skilled Study Start Up Associate II to join our team at ICON. As a key member of our team, you will be responsible for collecting, preparing, reviewing, approving, processing, and tracking regulatory and site-level critical documents required for study site activation.Key ResponsibilitiesCollect, prepare, review, approve,...
-
Regulatory Compliance Specialist
hace 2 meses
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...
-
Study Start Up Associate II
hace 4 semanas
Ciudad de México, Ciudad de México Icon Plc A tiempo completoAbout ICONAt ICON, we pride ourselves on being a world-leading healthcare intelligence and clinical research organization. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.We advance clinical research by providing outsourced services to pharmaceutical,...
-
Operations and Start-Up Leader
hace 4 semanas
Ecatepec de Morelos, México Nestle Operational Services Worldwide Sa A tiempo completo**Job Purpose:**As a CAPEX project team member, you will play a crucial role in ensuring vertical start-up and sustained performance by properly preparing and leading the start-up phase.**Key Responsibilities:**Assist in the development of User Requirement Specifications during the project design phase by identifying local site operational...
-
Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo**About the Role**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Worldwide Clinical Trials. As a key member of our team, you will be responsible for planning, initiating, and tracking documents required for regulatory submissions, essential documents collection, review, and provision of country/site/EC requirements to...
-
Regulatory Affairs Specialist
hace 2 semanas
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo**Role Overview**At Worldwide Clinical Trials, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for planning, initiating and tracking documents required for regulatory submissions, essential documents collection, review and provision of country/site/EC requirements to support achievement of site...
-
Study Start Up Associate II
hace 3 semanas
Ciudad de México, Ciudad de México Icon A tiempo completoJob SummaryThe Study Start Up Associate II will be responsible for collecting, preparing, reviewing, approving, processing, and tracking regulatory and site-level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines, and the principles of ICH/GCP.This role will also...
-
Regulatory Submissions Manager
hace 4 semanas
Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completoRegulatory Submissions ManagerWe are seeking a highly skilled Regulatory Submissions Manager to join our Study Start Up team in Mexico City. This role plays a key part in the clinical trial management process at Medpace, where you will utilize your expertise to develop and grow your career.ResponsibilitiesManage and execute all aspects of global start-up...
-
EHS/HSE Content Manager and Regulatory Specialist
hace 2 semanas
Ciudad de México, Ciudad de México ERM A tiempo completoEHS/HSE Content Manager and Regulatory SpecialistAt ERM, we're redefining the way organizations manage their environmental, health, and safety (EHS) regulatory requirements. We're looking for a skilled EHS/HSE Content Manager and Regulatory Specialist to join our team and help us achieve our mission. About the RoleThis is a senior-level position that...
-
Regulatory Submissions Manager
hace 4 semanas
Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completoRegulatory Submissions ManagerWe 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.ResponsibilitiesManage and execute all aspects of global start-up efficiently;Perform quality checks on submission documents and site...
-
Regulatory Specialist
hace 1 mes
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob Title: Regulatory & Start Up Specialist 2, cFSPLocation: Mexico - Full home basedJob Overview:This 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. This includes supporting site qualification, site level...