Senior Manager, Epidemiology

Job not on LinkedIn

🔥 12 minutes ago

🏄 California, Pennsylvania – Remote

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $141.6k - $212.4k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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