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Experience with industry cross-collaboration amongst functions involved in product launches (medical affairs, commercial/marketing, market access, clinical development, regulatory, etc. Experience in conducting and reviewing prospective/retrospective observational studies; economic modeling studies; familiarity with COA/PRO development, validation research and clinical trial implementation.
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Ability to guide early clinical trial design with COA strategies in alignment with Regulatory, Commercial and Market Access objectives, with the ability to lead HEOR contributions to clinical trial documents (e.g., protocols, protocol manuals, clinical study reports.
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Provides HEOR strategic expertise under the supervision of the manager, to support clinical trial design and efficient implementation of HEOR-related contributions (e.g., COAs). Independently identifies appropriate internal and external data resources and external experts to execute strategies and research activities led by HEOR.
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Conduct Health Economics and Outcomes Research projects under the supervision of the manager to support the Value Proposition to Regulators, Payers, Patients, Prescribers, and Policy-makers. Experience in drafting of study reports, creation of presentation materials from study reports, ability to present scientific research to non-scientific audiences.
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M.S. or Ph. D. in health economics , health services research, pharmaceutical sciences, or related discipline. Assures alignment of research activities with Scientific Research Annual Plan; communicates any changes from plan in timely manner.
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Monitors scientific, regulatory and reimbursement/access trends, events and policies for their potential to affect current research responsibilities in order to provide advice/guidance on best course of action.
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Applies extensive technical knowledge and experience to plan, execute, and interpret research and data collection activities. Brand plan, early clinical trial design with COA strategies.
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Familiarities and expertise into COA/PRO for early clinical trial. Experience in conducting HEOR-related projects (e.g., real-world evidence [RWE] generation, economic modeling, perform literature reviews), including the ability to develop study protocols and output reports (e.g., manuscripts, posters, final reports, data on file.
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Experience in devising robust HEOR-related evidence-based strategies to inform early asset programs, enable differentiated product labeling and positioning, and help optimize reimbursement and access.
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The Emory University School of Medicine is ranked among the nation’s finest institutions for education, biomedical research, and patient care, and the Department of Pediatrics was recently ranked #1 in such departments in the U.S. in research funding by the NIH. Both Children’s and Emory support the ongoing professional and leadership development of physicians while maintaining a healthy balance between academics and clinical work and rewarding excellence and productivity in both.
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As a Regulatory Affairs Specialist, you'll play a pivotal role in upholding our mission by ensuring regulatory compliance and promoting the well-being of pets worldwide. As a Regulatory Affairs Specialist, you'll be an integral part of our mission-driven team, working collaboratively to ensure that our products meet the highest standards of safety, quality, and regulatory compliance.
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Join us as we continue to grow, the Clinical Research Coordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines.
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Licenses and Certifications Preferred: Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC.
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About GWUH: GW Hospital is a 385-bed tertiary care, academic medical center located in downtown Washington, DC. Featuring a Level 1 Trauma Center and a Level 3 NICU offers clinical expertise in a variety of areas including cardiac, cancer, neurosciences, women’s health, and advanced surgery including robotic and minimally invasive surgery.
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STATE VETERANS' SERVICE OFFICER – MIAMI FLORIDA DEPARTMENT OF VETERANS’ AFFAIRS Bureau of Field Services VA Medical Center Miami, Miami - Dade County Starting Annual Salary: $44,480.02 Paid Bi-weekly Excellent retirement package and optional deferred compensation plan.
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clinical research affairs jobs Title: director Company: Biophase
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