Regulatory & Start Up Specialist I - Central Hub

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...

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...

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...

**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...

**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...

**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,...

**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...

External Job Description **Job Overview** A Central Monitor is a key skilled and clinically experienced team member of IQVIA Central Monitoring Department. Provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts. **Essential Functions**: -...

**POSITION TITLE**: Regulatory Affairs Specialist **REPORTS TO**: Manager, Regulatory Affairs or Designee **BASIC FUNCTIONS**: **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory...

The Site Activation Partner I (SAP I) is responsible for leading or supporting operational activities from start up to close out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. Responsibility within a country and may span over more...

**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...

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...

**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...

Parexel is looking for multiple Clinical Study Team Assistant I in Mexico, Argentina or Brazil! The Clinical Study Team Assistant I (CSTA I) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating...

**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 - Acts as liaison with internal stakeholders in the provision of these services. - Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: assessment of regulatory documents, preparation and assembly of global regulatory...

The Clinical Study Team Assistant I (CSTA I) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating Procedures (SOPs). The role collaborates with global study team members and is responsible for...