Senior Medical Editor, Regulatory Documents, QC

🕒 Abril 23

🌵 Arizona, Maine, +3 estados a mais – Remoto

🌵 Arizona – Remote 🦞 Maine – Remote 🏖️ New Jersey – Remote 🏈 Ohio – Remote ⚓ Rhode Island – Remote

💵 $62.000 - $108.600 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 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

Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements • Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed • Perform QC review of documents • Verify data in documents against the source tables, figures, and listings and format tables • Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor if deliverables are at risk • Provides technical support and expertise as appropriate • Conducts training of medical editing staff and functions as a mentor • Serves as project lead for deliverables of assigned complex and/or large medical writing projects • Serves as a member of the medical writing team for projects with medical writing deliverables • Copyedits assigned documents • Performs quality review of assigned documents to ensure accuracy

🎯 Requisitos

• Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards • Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed • Perform QC review of documents • Verify data in documents against the source tables, figures, and listings and format tables • Monitors timelines and budgets for assigned projects • Provides technical support and expertise as appropriate • Conducts training of medical editing staff and functions as a mentor • Advises medical writers, medical editors, and study teams on quality review • Serves as project lead for deliverables of assigned complex and/or large medical writing projects • Serves as a member of the medical writing team for projects with medical writing deliverables • Copyedits assigned documents • Performs quality review of assigned documents to ensure accuracy • Contributes to the development of process improvement tools

🏖️ Benefícios

• Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time