Senior Manager, Epidemiology

🕒 Setembro 11

🏄 California, Pennsylvania – Remoto

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $141.600 - $212.400 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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👻 Score fantasma 23%

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• Aberta há 62 dias.
• As vagas desta empresa costumam ser preenchidas em 21 dias.

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Jazz Pharmaceuticals

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2003

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

A Jazz Pharmaceuticals é uma empresa biofarmacêutica dedicada ao desenvolvimento de medicamentos inovadores que atendem a necessidades médicas não atendidas. Com um forte compromisso com pesquisa e desenvolvimento, a Jazz foca em criar terapias que transformam vidas, enfatizando a importância da colaboração, diversidade e engajamento dos funcionários em suas operações. A empresa se orgulha de transformar a vida dos pacientes por meio de suas ofertas de produtos significativas e uma cultura que promove entusiasmo e flexibilidade.

Descrição

• Conduct or outsource literature searches to identify epidemiology data on disease incidence, prevalence, mortality, natural history, demographics, co-morbidities, treatment patterns and concomitant medications • Contribute epidemiology data to regulatory submissions supporting Clinical Development Programs and other processes requiring epidemiological data • Provide top of the patient funnel data for forecasting and commercial purposes • Identify appropriate US and EU secondary data sources, including administrative claims and EMR databases • Lead Requests for Proposal and Statements of Work for outsourced epidemiology studies • Support multi-disciplinary non-interventional Phase IV study teams and deliver study-related regulatory submissions • Develop statistical analysis plans with project biostatisticians • Manage external investigators, project managers and operational leads at CROs and Data Providers • Communicate with US and EU Regulatory Leads regarding submission deliverables and PMR/PMC timelines • Develop partnerships with Clinical Development, Medical Affairs, Biostatistics and Regulatory Affairs stakeholders • Communicate study plans, timelines, budgets, progress reports and study results to internal teams • Present research findings at scientific congresses and co-author peer-reviewed manuscripts • Ensure compliance with applicable laws, regulations and regulatory guidelines

🎯 Requisitos

• Advanced degree (MS, MPH, MSPH, or PhD) in epidemiology or a related discipline (health services research, outcomes research, public health, pharmaceutical sciences) • At least 2 years of experience in the pharmaceutical industry, CRO or in academia • Experience with rare disease studies • Project management experience in planning, budgeting, resourcing and executing the operational tasks required to complete a research study • Experience successfully coordinating cross-functional processes • Experience analyzing secondary data sources (administrative claims and EMR databases) • Excellent oral and written communication skills in English • Solid understanding of epidemiology and biostatistics • Experience managing multiple projects and reprioritizing work when necessary • Capable of working remotely with minimal supervision • Proficiency with MS Word, Excel and PowerPoint • Ability to travel approximately 10% time • Therapeutic area experience in oncology; strong knowledge of SEER data and use of SEER*Stat platform • Experience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews) • Experience conducting post-marketing safety studies of marketed medicines • Experience supporting Clinical Drug Development, Safety, Forecasting and Medical Affairs teams within a biopharmaceutical company • Experience authoring protocols, study reports, and epidemiology sections of RMPs for regulatory submissions to FDA, EMA and other health authorities • Data analysis programming skills (SAS, Stata, R) or recent hands-on experience using an RWE platform technology

🏖️ Benefícios

• Discretionary annual cash bonus or incentive compensation • Discretionary equity grants • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation • Remote work arrangement

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