Regulatory Specialist 2, Fsp

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 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...

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...

In 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 legislation Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...

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 legislation Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and...

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

**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...

Responsible for supporting the SRPs and investigator for Targeted Sites: **Clinical Trial Site Activation & Conduct** - Assist with study site activation activities to ensure timely site activation - Register investigator sites in Client registries, as required - Support and/or coordinate central Investigator Review Board (IRB) submissions when needed. -...

**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,...

Job Overview Perform monitoring and site management work for a variety of protocols, site and therapeutic areas. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference...

**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...

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 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...

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)...

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...

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...

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...

**The Otte Polo Group is a U.S. based conglomerate of businesses offering tech support, domestic and international contact center, answering services, and 3PL fulfillment solutions. Our brands include Geeks on Site, Responsive Call Center, Phase V Fulfillment, amongst others. We operate from several US offices, and a few in Latin America. We take pride in...

**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...

IQVIA Biotech, a global full service CRO providing flexible and tailored clinical solutions to smaller biotech companies, is seeking additional talent within our **Site File Operations team**. Our **Site File Specialist II **opportunity requires: BS/BA/BSc, or equivalent, plus 2 years of related experience; regulatory document review experience preferred....