REMS Project Manager

🕒 Outubro 6

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷‍♀️ Gerente de Projetos

👻 Score fantasma 10%

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.

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UBC

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2003

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A UBC é uma empresa dedicada a melhorar os resultados dos pacientes, conectando terapias especializadas aos pacientes que delas necessitam. Eles oferecem soluções modernas e personalizadas, focando em acesso, segurança e geração de evidências para produtos biofarmacêuticos. A UBC é especializada em desenvolvimento de evidências, gestão de riscos e acesso do paciente, utilizando dados do mundo real e tecnologias inovadoras para otimizar a jornada de saúde e garantir o uso eficaz de medicamentos.

Descrição

• Plan, organize and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope • Oversee all aspects of project conduct from start-up through close-out • Execute operational aspects of assigned project activities and special projects • Manage projects according to scope of work and contracted budget • Manage project revenue and invoicing • Ensure projects follow UBC and applicable client SOPs • Develop plans and processes to achieve contracted milestones • Monitor project progress and compliance against established plans • Prepare project timelines and coordinate deliverables • Prepare meeting agendas and create minutes and action logs • Track project budgets against contract milestones • Serve as UBC’s primary sponsor contact • Coordinate and facilitate internal and external project meetings • Resolve project team member questions • Supervise functional areas supporting projects and cross-functional project teams • Ensure project training occurs and assist with training • Develop content and lead internal and external kick-off meetings • Negotiate budgets and assist with contract-language remediation • Present project information at bid defenses, client meetings, and monthly project review meetings • Maintain audit-ready project documentation • Participate in sponsor and regulatory audits as required • Coordinate investigator meetings as required • Assist with protocol development, patient/subject consent forms, REMS, and REMS supporting documents as required • Lead process-improvement activities • Establish, implement, and track project and initiative metrics • Coordinate and ensure maintenance of the Trial Master File as required • Perform CSS and CRA duties as needed • Perform other duties assigned by management • Supervise the project team

🎯 Requisitos

• Bachelor’s Degree or equivalent experience • Previous managerial, or relevant experience, required • Very good written verbal and non-verbal communication skills • Very good supervisory skills • Very good interpersonal skills • Very good presentation skills • Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution • Solution driven • Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.) • 10% travel as required

🏖️ Benefícios

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match* • Tuition reimbursement • Flexible work environment • Discretionary PTO (Paid Time Off) • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short term disability • Long term disability • Life insurance • Discount programs