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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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Support Danaher Diagnostic Operating Company Medical and Scientific Affairs and Government Affairs organizations on their strategy so that it maximizes patient impact at scale. Prior roles in industry Medical and Scientific Affairs and/or Government Affairs functions a plus.
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Reporting to the CSO, Danaher Diagnostics, this position will provide medical/clinical, scientific, and technological insights and related expertise to the Diagnostics Operating Companies (OpCos) in developed economies and high-growth market countries/regions.
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Cultivate engagements between Danaher and biopharma key opinion leaders (KOLs) in neurology and related disease areas; possess in depth knowledge of biopharma drug pipelines in neurology and anticipate the diagnostic needs of pharma (from Research Use Only (RUO) to Clinical Trial Assay (CTA) to In Vitro Diagnostics (IVD) inclusive of Companion Diagnostics (CDx) and Lab Developed Tests (LDTs.
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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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The Administrative units include the Offices of the Dean, Vice Dean, Associate Dean for Student Affairs, Associate Dean for Research, Associate Dean for Clinical Affairs, Associate Dean for Extramural Clinical Practices, Assistant Dean for Dental Education and Informatics, Assistant Dean for Educational Support and Faculty Development, Assistant Dean for Academic Success and the Assistant Dean for Business Operations and Financial Affairs.
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As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of clinical and scientific data e.g., therapeutic benefit, safety and medical value); educational initiatives ,scientific communications, and digital engagement.
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In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their studies.
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The CS also has a strategic role in partnership with Medical/Scientific Affairs to develop operating plans and study strategies in support of the Clinical Development and Life Cycle plans.
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The Postdoctoral Clinical Research Fellows is a 12-month position designed to assist in the research at the Advent Health Research Institute (FHRI) and participates in Industry/National Institute of Health (NIH)/Pharmaceutical and government sponsored and investigator-initiated research that supports the FHRI scientific research plan.
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The Medical Science Liaison (MSL) is a field-based scientific expert that executes Pacira’s medical affairs strategy. The primary role of the MSL is to conduct scientific exchange with Health Care Providers (HCPs), communicate clinical and business insights to Pacira, and support evidence generation initiatives in the assigned therapeutic area(s) within a specified territory.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.Demonstrated organizational leadership skills at both functional and enterprise levels.
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Collaborate with cross-functional teams, including Biology, Biologics, Clinical Operations, Clinical Development, and Regulatory Affairs functions, to align biomarker and CDx strategies with overall program objectives.
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Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it.
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clinical scientific affairs jobs Company: Biophase
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