Specialist, Regulatory and Site Activation

Vaga não está no LinkedIn

🕒 6 dias atrás

🇲🇽 México – Remoto

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🚔 Conformidade

👻 Score fantasma 25%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Lifelancer

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2020

💼 Consultoria

🏥 Saúde

📦 Logística

💰 Pre Seed Round em 2022-03

Consulting • Healthcare • Logistics

Lifelancer é uma plataforma de contratação de talentos impulsionada por IA que conecta empregadores a profissionais qualificados nos setores de Ciências da Vida, Farmacêutico e TI. Ela permite que indivíduos criem perfis exibindo suas habilidades, sejam correspondidos com empregos ou projetos internacionais bem remunerados, e facilita a contratação e folha de pagamento para empregadores em vários países. A plataforma visa simplificar o processo de contratação com uma captação eficiente usando IA e suporte de conformidade.

Descrição

• Support regulatory submissions, site activation, and maintenance for awarded projects • Plan, initiate, and track documents required for regulatory submissions • Collect, review, and provide country, site, and ethics committee requirements • Support end-to-end site start-up from site identification through site activation and maintenance • Serve as the primary point of contact for sites and country-level regulatory and site activation activities • Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents • Review and advise on country timelines • Communicate submission status and action plans to the Regulatory Affairs Manager and project team • Collect, receive, and perform initial reviews of study-specific site regulatory and essential documents • Track regulatory documents by site and country and follow up as needed • Identify country/site risks and develop mitigation strategies • Advise on country regulatory strategies • Maintain communication with sites to ensure timely completion of start-up and maintenance activities • Provide updates on changing regulatory requirements and support interpretation of new regulations • Maintain the regulatory intelligence database for the assigned country • Comply with SOPs, ICH GCP, and applicable regulations • Perform local quality control of submission dossiers when required • Act as a contact point for translation review of submission documents • Perform other assigned duties

🎯 Requisitos

• Minimum 2-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or another related science • Minimum 2 years of experience in clinical research, preferably in site activation and/or regulatory-related function • Preferred minimum of one year of previous experience within the pharmaceutical/CRO industry • Good knowledge of ICH GCP, relevant clinical research conduct guidance, and country regulations • Fluent in the local language • Working knowledge of English • Strong organizational and management skills • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills • Excellent written and verbal communication skills • Proficiency in Microsoft Word, Excel, and PowerPoint • Aptitude for contemporary digital systems is helpful • Ability to handle multiple tasks in a fast-paced, changing, deadline-oriented environment • Ability to prioritize and adapt between detailed and strategic activities while maintaining delivery timelines and quality • Ability to initiate and develop relationships with local investigators and key site personnel

🏖️ Benefícios

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible, hands-on leadership • Equal employment opportunities • Employee experience focused on respect and inclusion