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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities.
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You will be responsible for: Design, implement, analyze, and report findings from targeted statistical research studies; provide consultation and guidance to researchers on experimental design, statistical research methodologies, and scientific standards for in vivo/in vitro studies, asay development, biomarker researches, and genetics/omics data analyses etc to advance drug development research.
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PhD and/or MD in relevant scientific field such as pharmacokinetics, pharmacometrics, clinical pharmacology, biological/pharmaceutical sciences, bioengineering, biostatistics. Lilly is looking for inventive, motivated and eager scientists to join the Global Pharmacokinetics/Pharmacodynamics and Pharmacometrics Team. PK/PD & Pharmacometrics scientists are functional leaders in research and development throughout the value chain from preclinical lead molecule identification to clinical post-drug approval.
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Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies or programs and contribute to development of modern program/trial design methodologies with a focus on real world evidence (RWE) gathering, analysis and interpretation.
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The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.
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Review identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs.
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Preferred experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring and scientific expertise.
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Education, Knowledge, Skills and Abilities Preferred: BSN PreferredMandatory education on human subject research and GCP (CITI Training and Certification)Knowledge of clinical trials and the regulation (local, state, and federal) of suchFamiliarity with basic scientific and healthcare principles and terminologyAbility to work in a fast-paced environment and manage competing tasks and demandsLicenses and Certifications Required:NJ State Professional Registered Nurse License.
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The Research Associate will work under the direction of the Douglas Dillon Senior Fellow for Africa Studies, focusing on U.S. foreign policy with respect to political and security issues, civil society, democracy, corruption, and religion in Sub-Saharan Africa.
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Work closely with multidisciplinary scientific groups including discovery specialists and in vivo team members. I am partnered with an exciting Biotech company out of Thousand Oaks, CA looking to grow their team with a Research Associate / Senior Research Associate.
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Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent.
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Serve as Medical Affairs therapeutic area expert on Global Publications and Scientific Message Platform committees and other support for Scientific Communications. Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
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Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products.
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MSLs provide medical information through scientific exchange in a fair- balanced manner and provide clinical/scientific support for Bristol Myers Squibb and the Medical Affairs department at the direction of Medical Affairs management.
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clinical research scientific affairs jobs Title: director Company: Regeneron Pharmaceuticals Inc
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