FSP - Sr. Regulatory and Start Up Specialist in Brazil

Há 7 dias

São Paulo, Brasil IQVIA LLC Tempo inteiro

FSP - Sr. Regulatory and Start Up Specialist in Brazil page is loaded## FSP - Sr. Regulatory and Start Up Specialist in Brazillocations: São Paulo, Braziltime type: Full timeposted on: Posted Todayjob requisition id: R 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 Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. • Prepare site regulatory documents, reviewing for completeness and accuracy. • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. • Review and provide feedback to management on site performance metrics. • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. • Inform team members of completion of regulatory and contractual documents for individual sites. • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines. • Provide local expertise to SAMs and project team during initial and on-going project timeline planning. • Perform quality control of documents provided by sites. • May have direct contact with sponsors on specific initiatives.**Qualifications needed**• Bachelor's degree in Health Sciences• +3 years of experience in the Site Activation/Regulatory department in:* ICF customization* Preparation and submission of studies in startups to local and central ethics committees* Collection of essential documents from the sites* Preparation of initial DDCM & DEEC for ANVISA* Experience in annual and final study reports• Advanced level of English• Excel knowledge#LI-Remote #LI-NRJIQVIA 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.#J-18808-Ljbffr

  • Fsp - Sr. Regulatory And Start Up Specialist In Brazil

    1 semana atrás

    São Paulo, Brasil Iqvia Tempo inteiro

    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 Single Point...

  • FSP - Sr. Regulatory and Start Up Specialist in Brazil

    1 semana atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    Sao Paulo, Brazil | Full time | Home-based | R1518042Perform 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...

  • FSP - Sr. Regulatory and Start Up Specialist in Brazil

    Há 7 dias

    São Paulo, Brasil BZL IQVIA RDS Brasil Ltda Tempo inteiro

    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 Single Point of...

  • FSP - Sr. Regulatory and Start Up Specialist in Brazil

    Há 5 dias

    São Paulo, Brasil IQVIA Tempo inteiro

    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 Single...

  • Fsp - Regulatory & Start Up Specialist

    2 semanas atrás

    São Paulo, Brasil IQVIA Tempo inteiro

    Under moderate supervision, the **Site Activation Specialist**executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites...

  • FSP - Regulatory and Start-up Specialist

    2 semanas atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    Under moderate supervision, the Site Activation Specialist executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements  at the regional, or country level.Prepares and manages site documentation; reviews and negotiates site  documents and contracts with sites...

  • FSP - Regulatory and Start-up Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    Under moderate supervision, the Site Activation Specialist executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and...

  • FSP - Sr. Regulatory and Start Up Specialist in Brazil

    1 semana atrás

    São Paulo, São Paulo, Brasil IQVIA Tempo inteiro

    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 Single Point...

  • Fsp - Regulatory And Start-Up Specialist

    1 semana atrás

    São Paulo, Brasil IQVIA Tempo inteiro

    Regulatory Officer - Agrochemical Sector (International Scope)📍 Location: Netherlands (Relocation Support & Visa Sponsorship Provided)Are you an experienced regulatory professional with a passion for plant science, compliance, and international markets? A global player in the agrochemical and crop protection sector, headquartered in the Netherlands, is...

  • Line Manager Regulatory and Start Up

    1 semana atrás

    São Paulo, Brasil IQVIA LLC Tempo inteiro

    Line Manager Regulatory and Start Up page is loaded## Line Manager Regulatory and Start Uplocations: São Paulo, Braziltime type: Full timeposted on: Posted Yesterdayjob requisition id: R **Job Overview** Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs,...