Study Start Up and Regulatory Affairs Specialist

🕒 Outubro 20

🇬🇧 Reino Unido – Remoto (RU)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 18%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.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.

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ERGOMED

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1997

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

ERGOMED é um grupo global que oferece serviços especializados para as indústrias de biotecnologia e farmacêutica. Opera sob diferentes linhas de serviço, incluindo Ergomed Clinical Research, PrimeVigilance, e ADAMAS Consulting, e é dedicada a fornecer capacidades completas de organização de pesquisa clínica (CRO). Com foco em oncologia, doenças raras e estudos complexos, também oferece serviços completos de farmacovigilância e informações médicas, bem como auditorias abrangentes de GxP. A Ergomed está comprometida em apoiar o desenvolvimento de medicamentos com presença global em cerca de 100 países.

Descrição

• Lead and coordinate activities required to achieve site initiation readiness • Provide subject matter expertise and ensure regulatory compliance • Serve as liaison between internal teams, clients, and external stakeholders • Deliver assigned study start-up and regulatory milestones within defined scope • Make independent decisions regarding regulatory processes and documentation approaches • Lead study start-up and regulatory activities for assigned countries or medium-complexity projects • Prepare, review, and quality-control regulatory and study start-up documentation, including submissions, essential documents, and translations • Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments • Review labels, patient information sheets, diary cards, insurance, and other documentation for ICH-GCP and country-specific compliance • Provide regulatory and Study Start-Up strategic input to internal and external customers • Develop regulatory strategies, Study Start-Up Plans, joint operating procedures, and core documents • Identify and escalate risks that may jeopardize project deliverables and support corrective/preventive actions • Perform other work-related duties as assigned

🎯 Requisitos

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience • Previous experience within the pharmaceutical or CRO industry or a regulatory body • Good knowledge of ICH GCP and national regulations for territories of competency • Good understanding of specific country requirements pertaining to Study Start-Up/Regulatory delivery in multiple countries within Europe and/or the Americas • Ability to lead study start-up and regulatory activities for assigned countries or medium-complexity projects • Ability to prepare, review, and quality-control regulatory and study start-up documentation • Knowledge of clinical site agreements, ancillary agreements, amendments, and country regulations • Ability to review labels, patient information sheets, diary cards, insurance, and related documentation • Ability to contribute to complex technical, scientific, and legal documentation • Ability to arrange and/or review translations of essential documents • Ability to develop regulatory strategies, Study Start-Up Plans, joint operating procedures, and core documents • Ability to identify and escalate project risks and support corrective/preventive actions

🏖️ Benefícios

• Flexible/remote work arrangements (employees can work remotely) • Work-life balance • Career growth opportunities • Collaborative international team environment • Trusted ownership and autonomy • Opportunity to contribute to meaningful work helping bring safe and effective pharmaceutical treatments to patients

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