Senior Manager, Epidemiology

🕒 il y a 18 jours

🏄 California, Pennsylvania – Distant

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $141 600 - $212 400 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

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Jazz Pharmaceuticals

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 2003

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals est une entreprise biopharmaceutique dédiée au développement de médicaments innovants répondant à des besoins médicaux sérieux non satisfaits. Avec un fort engagement envers la recherche et le développement, Jazz se concentre sur la création de thérapies transformatrices, mettant en avant l'importance de la collaboration, de la diversité et de l'engagement des employés dans ses opérations. L'entreprise est fière de transformer la vie des patients grâce à ses offres de produits significatives et une culture qui favorise l'enthousiasme et la flexibilité.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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