Regulatory Specialist 2, Fsp
hace 2 semanas
**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
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Regulatory & Start Up Specialist 2, Cfsp
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**Regulatory & Start Up Specialist, c**FSP - US/CAN Support** Location: Mexico - Full home based **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.** This includes supporting **site...
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Site Activation Specialist
hace 1 semana
Desde casa, México IQVIA A tiempo completo**Site Activation Specialist for External Commerce (ComEx) - Homebased****Essential Functions**- Responsible for importations and exportation activities in Mexico for our FSP model- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.- Perform start up and site activation...
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Site Activation Specialist
hace 2 semanas
Desde casa, México IQVIA A tiempo completo**Site Activation Specialist for External Commerce (ComEx) - Homebased** **Essential Functions** - Responsible for importations and exportation activities in Mexico for our FSP model - Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. - Perform start up and site...
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Fsp - Regulatory & Start Up Specialist 2- Mex
hace 5 días
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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Regulatory Affairs Specialist
hace 2 semanas
Desde casa, México ICON A tiempo completoAs a Regulatory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**What you will be doing**:- Regulatory advice to drug development is key to ensuring our clients pursue first time right strategies to overall product development and to clinical programme...
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Regulatory Services Imports Specialist, Sponsor
hace 4 semanas
Desde casa, México IQVIA A tiempo completoThe** **Country Site Activation team is aiming to identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication.By joining us as a **Regulatory Services Imports Specialist in FSP **(Functional Services Partnership)**, **you will perform tasks at a country level associated with Study...
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Regulatory Affairs Specialist
hace 4 semanas
Desde casa, México ProductLife Group A tiempo completoIn the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico.**Responsibilities**:Provide guidance and support about Mexican and Central America legislationContribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...
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Regulatory Affairs Specialist
hace 4 semanas
Desde casa, México ProductLife Group A tiempo completoIn the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM.**Responsibilities**:Provide guidance and support about Mexican and Central America legislationContribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...
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Site Intelligence Specialist
hace 7 días
Desde casa, México Parexel A tiempo completoMexico, Remote**Job ID** R **Category** Clinical Trials**ABOUT THIS ROLE**:Parexel FSP is looking for a Site Intelligence Specialist in Mexico- The Site Intelligence Specialist (SIS) acts as a supportive team member for Regional Intelligence. Performs tasks for multiple Site Intelligence and Feasibility projects. Works under close supervision of Regional...
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Site Intelligence Specialist
hace 1 semana
Desde casa, México Parexel A tiempo completoMexico, Remote **Job ID** R0000029006 **Category** Clinical Trials **ABOUT THIS ROLE**: Parexel FSP is looking for a Site Intelligence Specialist in Mexico - The Site Intelligence Specialist (SIS) acts as a supportive team member for Regional Intelligence. Performs tasks for multiple Site Intelligence and Feasibility projects. Works under close...