FSP - Regulatory and Start Up Specialist
hace 6 horas
FSP - Regulatory and Start Up Specialist page is loaded## FSP - Regulatory and Start Up Specialistlocations: Mexico City, Mexicotime type: Full timeposted on: Posted Todayjob requisition id: R1520119**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 qualification**, site level regulatory green light and site **maintenance/close-outs**.**Essential Functions*** Participate in development of in-house model process documents.* For assigned sites and countries, serve as a primary site contact for end-to-end study activity.* Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.* Utilize systems and tools to track assigned activities and produce reports and metrics as needed.* Oversee essential document collection, tracking & 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 (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate or maintain sites for a study as appropriate.* **Qualifications*** Bachelor’s Degree in Life Science, Business Administration, Finance or related field or work experience equivalent.* Minimum of one year of relevant experience in the biopharmaceutical/CRO industry, **including experience in EC submission in Mexico.*** ICF customization experience* **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 skillsIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more atIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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FSP - Regulatory and Start Up Specialist
hace 2 semanas
Mexico City IQVIA A tiempo completoFSP - Regulatory and Startup Specialist Join to apply for the FSP - Regulatory and Startup Specialist role at IQVIA. 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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FSP - Regulatory and Start Up Specialist
hace 5 horas
Mexico City IQVIA A tiempo completoFSP - Regulatory and Startup Specialist Join to apply for the FSP - Regulatory and Startup Specialist role at IQVIA. 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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Mexico City IQVIA LLC A tiempo completoA global provider of clinical research services is seeking a Regulatory and Start Up Specialist in Mexico City. This role involves end-to-end site management, acting as a point of contact for investigative sites, and ensuring compliance with regulatory requirements. The ideal candidate will have a Bachelor’s degree in Life Sciences or related fields and at...
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Regulatory Submissions Coordinator
hace 5 horas
Mexico City Medpace A tiempo completoA clinical research organization in Mexico City is seeking a Regulatory Submissions Coordinator to support Regulatory Submissions and gain vital experience in study start-up. Responsibilities include providing support activities, ensuring compliance, and conducting document quality control. Requirements include a Bachelor's degree in Life Sciences, 1-3 years...
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Study Start Up Manager
hace 3 semanas
Mexico City Medpace A tiempo completoStudy Start Up Manager Join Medpace as a full‑time, office‑based Regulatory Submissions Manager in Mexico City. This role plays a key part in the study start‑up process, building on your experience in clinical trials and regulatory submissions. You will use your expertise to develop and grow your career while supporting our LATAM clinical trial...
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Study Start Up Manager
hace 5 horas
Mexico City Medpace A tiempo completoStudy Start Up Manager Join Medpace as a full‑time, office‑based Regulatory Submissions Manager in Mexico City. This role plays a key part in the study start‑up process, building on your experience in clinical trials and regulatory submissions. You will use your expertise to develop and grow your career while supporting our LATAM clinical trial...
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Regulatory Start-Up Lead – LATAM Trials
hace 5 horas
Mexico City Medpace A tiempo completoA leading clinical research organization in Mexico City is seeking an experienced Regulatory Submissions Manager for a full-time, office-based role. This position is crucial for the study start-up process, requiring a bachelor's degree in life sciences and at least 4 years of relevant experience. Candidates should be fluent in English and the local language...
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LatAm Regulatory Submissions Lead — Clinical Trials Start-Up
hace 2 semanas
Mexico City Medpace A tiempo completoA leading clinical research organization in Mexico City is seeking a Regulatory Submissions Manager to oversee the start-up process for clinical trials. This office-based role requires at least 4 years of relevant experience, strong communication, and leadership skills. Ideal candidates will manage global start-up activities and ensure the quality of...
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Experienced Study Start Up Specialist
hace 5 horas
Mexico City Medpace A tiempo completoJoin Medpace at our Mexico City office! As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining vital experience in study start up! You will be a productive member of the team, and will be mentored and supported as you develop your skills. Working directly with...
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LatAm Regulatory Submissions Lead: Study Start-Up
hace 2 semanas
Mexico City Medpace A tiempo completoA leading clinical research organization in Mexico City is seeking a Regulatory Submissions Manager to oversee the start-up process for clinical trials. Candidates should have at least 4 years of relevant experience with strong communication and leadership skills. The role is office-based with a focus on managing global start-up activities and ensuring the...
