Medical Communications Specialist – Project Manager

🕒 Maio 13

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $62.000 - $85.000 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

👷‍♀️ Gerente de Projetos

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Esta empresa já patrocinou vistos H1B no passado.

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Integra LifeSciences

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💰 $16.500.000 Series B em 2017-07

Integra LifeSciences é uma líder mundial em tecnologia médica com sede em Princeton, New Jersey. Na Integra LifeSciences, somos movidos pelo nosso propósito de restaurar a vida dos pacientes. Inovamos caminhos de tratamento para melhorar os resultados dos pacientes e estabelecer novos padrões de cuidados cirúrgicos, neurológicos e regenerativos. Oferecemos um portfólio abrangente de marcas de liderança de alta qualidade, que incluem AmnioExcel®, Aurora®, Bactiseal®, BioD™, CerebroFlo®, CereLink®, Certas® Plus, Codman®, CUSA®, Cytal®, DuraGen®, DuraSeal®, DuraSorb®, Gentrix®, ICP Express®, Integra®, Licox®, MAYFIELD®, MediHoney®, MicroFrance®, MicroMatrix®, NeuraGen®, NeuraWrap™, PriMatrix®, SurgiMend®, TCC-EZ® e VersaTru®. Nossa empresa possui escritórios, instalações de fabricação e pesquisa na Ásia, Austrália, Europa, Oriente Médio e Américas. Para as últimas notícias e informações sobre a Integra e nossos produtos, visite www.integralife.com.

Descrição

• Edits medical writing deliverables as required • Manages medical writing referencing and literature software and problem solves team issues coordinating with IT and software developers • Supervises project tracking systems, timelines, deliverables, dashboards, and workflow processes • Collaborates with project managers and facilitates effective communication between EU MDR stakeholders and project teams • Oversees secure document storage and retrieval within designated systems • Ensures adherence to industry standards, organizational policies, and medical device regulations • Leads team meetings by setting agendas, monitoring action items, and disseminating meeting notes and resources across the Medical Communications team • Manages vendor relationships to maximize project deliverables and optimize outcomes • Maintains version control and organization of medical communication documents and files • Manages departmental procedures and documentation, ensures compliance with clinical, regulatory, and quality requirements • Updates and monitors Global Standard Operating Procedures and support preparation for Change Review Board evaluations • Administers document management on company intranet and route materials for signature approvals • Monitors project risks and assess stakeholder needs to ensure alignment with departmental objectives

🎯 Requisitos

• Bachelor’s degree in scientific or healthcare discipline or equivalent experience in similar role is required • Minimum of 2 years’ experience in medical writing focused on clinical evaluations and PMCF with experience in editing and formatting • Capable of managing multiple priorities in fast-paced settings • EU MDR regulatory knowledge • medical writing • strong attention to detail • proficiency in project management • advanced skills in MS Office • proficiency with Distiller-SR and reference management tools including EndNote and Perfect-It.

🏖️ Benefícios

• medical • dental • vision • life insurance • short- and long-term disability • business accident insurance • group legal insurance • savings plan (401(k))