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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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The Prostate Cancer Radiopharmaceutical Senior Medical Science Liaison (MSL) is a key member of Global Medical Affairs, communicating scientific, clinical and technical information within the medical community, developing and maintaining strong collaborative relationships with Key Opinion Leaders and serving as a therapeutic and radiopharmaceutical expert with internal audiences.
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CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development. Director, CMC Regulatory Affairs. 15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Stay current with scientific literature and emerging technologies in the field of immunohistochemistry and clinical trial research and advancements in IHC technologies, biomarker discovery, and regulatory requirements for companion diagnostics, and integrate new methodologies into development strategies.
$120,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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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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Identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate working with Clinical Affairs Lead, Clinical Epidemiologist/Medical/Scientific Affairs Lead and Partner representatives.
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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 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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As a subject matter expert, you will be required to keep up to date with the latest scientific and clinical advancements in veterinary dermatology. This may include setting up collaborations with third parties to develop in-vitro assays, in-vivo disease models, establishing the preclinical and clinical development strategy for dermatology projects with our development teams, study protocol development, interpretation of study data, etc.
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Experience in other Medical Affairs functions (i.e., Publication Planning, Scientific communications, HEOR, etc.) Acquires and maintains a level of medical-scientific knowledge in endocrinology and/or rare disease involving clinical issues related to company’s products; able to interpret and disseminate pertinent scientific/clinical data and evaluates current and new information as it applies to company’s therapies.
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He/she will work in close collaboration with Luminex Research Departments, Regulatory Affairs, Scientific Affairs and Sales & Marketing to ensure effective and efficient conduct of clinical research activities in accordance with applicable regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products.
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Serve as an internal resource to scientific and clinical teams with software and data science needs at the Child Mind Institute and collaborating centers. General-purpose programming support for scientific and clinical projects.
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As the Belfer Center celebrates 50 years of impactful research and policy analysis at the nexus of science and international affairs, we are launching a major program on Emerging Technology, Scientific Advancement, and Global Policy.
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Work closely with the Head of Scientific Affairs & Strategic Partnerships and Scientific Affairs team to produce rapid, thoughtful responses to content-related requests from across Pfizer Oncology (CSO, Medical strategy, BoD, Investor Relations, colleagues, etc.
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clinical scientific affairs jobs Title: director Company: Biophase
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