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...

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...

Job Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Essential Functions - Oversee the execution of Site Activation (including pre-award/bid defense activities)...

**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,...

The** **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...

Unleash Your Potential:It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.:Join IQVIA and see where your...

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...

Job OverviewDirect and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.Essential Functions Oversee the execution of Site Activation (including preaward/bid defense activities) and/or...

**Unleash Your Potential**: **It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.**: **Join IQVIA and...

**Help create a healthier world**:START RIGHT HERE AT IQVIA.**: **Proficiency in English, both verbally and written are necessary.**: **Please submit resume in English.**: **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...

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...

**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...

Site Activation Specialist for External Commerce (ComEx) - HomebasedEssential 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 activities...

Study start up associates are integral in ensuring that clinical research sites are prepared and have the necessary tools and approvals needed to start the trial. As a study start up associate at ICON working in contracts your main role is to review and negotiate clinical site investigator contracts and budgets. Maintain communication with Investigative...

**Primary Responsibilities**: - Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction: - Management and oversight of Study Team shared spaces - TMF maintenance, compliance, and oversight - Analyze, interpret, and follow up on metrics - Management and oversight of Study...

**Job Description**: 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, as applicable in alignment with global...

In 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...

As 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...

Clinical Study Team Assistant II, FSP -The Clinical Study Team Assistant II (CSTA II) is an essential part of the Core Study Team and is responsible for driving and/or supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The role collaborates with global study team members and is...