Fsp - Regulatory and Start Up Specialist Mex

**Regulatory & Start Up Specialist, c**FSP.** 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 qualification**, site...

**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...

We are looking for a **Regulatory & Start Up Specialist** to join our cFSP team in a Home Based role! **Location**: Argentina & México **What You´ll Do** 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...

**Job Overview** Perform country-level tasks related to Site Activation (SA) activities at a global scope, ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and budgetary guidelines. This role may also involve maintenance activities. **Essential Functions**: - Serve as Single Point of...

**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...

**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,...

**Regulatory Publishing Specialist** The Regulatory Publishing Specialist provides experienced moderate, expedient and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product milestones. Serves in...

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Purpose**: - Clinical Trial Coordinator - Project Specialist is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. - CTC role was...

Mexico, 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...

At ICON, it’s our people that set us apart. 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. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

**Work Schedule** Other **Environmental Conditions** Office Trial Activation Approval Specialist I Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions,...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summarized Purpose**: Provides moderate, expedient, and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...

**Job Overview** **Essential Functions** - Assess Lifecycle Safety data for reportability to relevant authorities, including EudraVigilance, and track reportable cases. - Report to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups per legislation, within timelines, and in a format compatible with...

Job Overview Under general supervision, perform tasks at a country level associated with site activation 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...

**Summarized Purpose**: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local,...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - Collaborates with multiple team members in a matrix environment for the effective delivery of site activation or amendments within assigned projects. - Assists with coordination of the flow of information between internal teams, clients, or functional departments involved in site...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Purpose**: Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation...