Associate Ii, Tmf Operations - Brazil - Remote

buscojobs Brasil; Criciúma; Teletrabalho; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

Uma empresa global busca um Associate II para operações TMF, responsável pela gestão de documentos essenciais em conformidade com práticas regulatórias e melhores práticas da indústria. O cargo envolve desafios em um ambiente dinâmico e oferece oportunidade de contribuir para a equipe global na entrega de objetivos departamentais.

Qualificações

• Experiência de 1-2 anos em áreas relevantes.
• Conhecimento de trabalho em industrias altamente reguladas (desejável).
• Proficiente na utilização de repositórios eletrônicos de documentos.

Responsabilidades

• Processar, revisar e resolver documentos rejeitados do Trial Master File (TMF).
• Executar controle de qualidade periódico do TMF para garantir conformidade regulatória.
• Fornecer suporte administrativo para o RMC Lead.

Conhecimentos

Habilidades interpessoais

Proficiente em Microsoft Word

Proficiente em Microsoft Excel

Formação académica

Grau universitário (preferencialmente em Ciências da Vida)

Ferramentas

eTMF

Descrição da oferta de emprego

What the Associate II, TMF Operations does at Worldwide

The Associate II, TMF Operations is responsible for the processing, maintaining and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, ALCOA principles, country regulations and industry best practice. The Associate will support the delivery of department objectives in ensuring the management essential documents. This is a global role and will require working with Worldwide Project Team members.

What you will do

• Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.
• Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
• Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
• Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
• Escalate any TMF Quality issues in a timely manner to RMC Lead.
• Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).

What you will bring to the role

• Proficiency in use of an electronic document repository or eTMF, and document recognition skills.
• Strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
• Sound judgment and ability to identify decisions requiring supervisory approval.
• Proficiency in Microsoft Word and Excel.

Your experience

• University Degree preferred (Life Science desirable)
• 1-2 years of relevant experience
• Knowledge of working within a highly regulated industry (desirable)