Principal Rassu Specialist

Join The Cti Team; Portugal; On-site; EUR 60,000 - 90,000; Full time

Job summary

A CTI, empresa global de pesquisa clínica, procura um Principal RASSU Specialist para liderar atividades regulatórias em estudos clínicos em Portugal. O candidato ideal tem sólida experiência em conformidade regulatória, preferencialmente em CROs, e domínio de requisitos de IRB/EC locais.

Principais funções: assessorar equipas, preparar e submeter documentação regulatória, adaptar ICF conforme pedidos de IRB e manter a qualidade de arquivos e rastreabilidade segundo SOPs.

Qualifications

• Associates ou bacharel em área de saúde (ou equivalente)
• Mínimo de 8–10 anos de experiência regulatória em indústria farmacêutica ou CRO
• Fluência no inglês falado e escrito

Responsibilities

• Assistir/assessorar equipes de projeto quanto a requisitos regulatórios para estudos clínicos
• Realizar avaliações de conformidade conforme requisitos dos países e notificar os gerentes de projeto de achados
• Revisar e adaptar documentos do estudo de acordo com requisitos de cada país/site
• Conduzir submissões a IRB/IEC e outros órgãos regulatórios conforme necessário
• Coletar, verificar e assegurar a qualidade de documentação regulatória
• Interagir com equipes e CPCs, CRAs e PMs para correções de documentos
• Preparar pacotes regulatórios conforme SOPs e realizar QC de documentação
• Adaptar o Formulário de Consentimento (ICF) conforme solicitações de IRB/EC
• Preparar/ QC de formulários de aplicações clínicas (CTA, XML)
• Responder a cartas de deficiência de IRB/IEC/CA
• Auditar internamente regulatórios e treinar equipe regulatory
• Desenvolver SOPs e monitorar atualizações de processos
• Gestão de orçamentos de sites e contratos por país/região

Skills

Regulatory experience

English (fluent)

Education

Associate’s or bachelor’s degree

Job description

Principal RASSU Specialist

Empresa : Join The Cti Team Tipo de Emprego : Periodo Integral Portugal

Descrição do Emprego - Principal RASSU Specialist

** Please submit your application in English **

WhatYou'llDo:

• Assist/Advise project teams on all regulatory requirements for clinical studies
• Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings
• Review and adapt study specific documents according each country and sites requirements
• Perform / oversee IRB/IEC/ and/ or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirements
• Receive and process study documentation from sites, check content and quality as well as completeness
• Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review
• Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements and /or perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements
• Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracy
• Preparation and/or quality check and filing of site adapted ICF according to local requirements
• Prepare or/and QC Clinical Trial Application forms (e.g. CTA, XML), where applicable
• Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
• Respond to Deficiency Letters from IRB/IEC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements
• Compiling and/or assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
• Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed
• Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
• Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
• Independently prepare for Sponsor or Agency audits and inspections
• QC and QA of various study related Regulatory documents and reports
• Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
• Attend internal and external study meetings and regulatory status reports for each site and country during study meetings
• Independently represent the Regulatory Department in capabilities and bid defense presentations
• Independently train and mentor less experienced Regulatory staff and other CTI functional department staff regarding regulatory work
• Develop relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs
• Sites budgets and Sites contracts management, depending from Countries/Regions

WhatYou'llBring:

• Associate’s or bachelor’s degree in allied health field such as nursing, pharmacy, or health science or the equivalent relevant experience
• A minimum of 8 - 10 years relevant pharmaceutical or CRO Regulatory experience
• Fluent in spoken and written English

AboutCTI

• AdvanceYourCareer–Weinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals.
• JoinanAward-WinningTeam–Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you’llhaveopportunitiestogivebacktoyourcommunityandtheworld.
• MakeaLastingImpact–AtCTI,yourworkdirectlycontributestoadvancingmedicine.You’llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost.

PleaseNote

• WewillnevercommunicatewithyouviaMicrosoftTeamsortextmessage
• Wewillneveraskforyourbankaccountinformationatanypointduringtherecruitmentprocess

Sobre a empresa

Join The Cti Team

CTI, a full-service contract research organization, was founded in 1999 to provide therapeutic expertise to the pharmaceutical and biotechnology industry across a range of services.

Ler mais sobre a empresa