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The Director, Regulatory Affairs at CPS, Inc. will serve as the leading expert in Scientific & Regulatory Affairs, overseeing all facets of U.S. and international regulations (EU, CAN, AUS, and others), alongside the management of 3 rd party certifications for our entire product portfolio.
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ResponsibilitiesA day in the life of a Clinical Research Nurse at Hackensack Meridian Health may include:Assists the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit and accrual potential.
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Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Diabetes and Obesity Business Unit – Global Medical Affairs Senior/Executive Director is an integral member of the medical affairs team for strategic planning in the support of launch and commercialization activities to meet patients’ needs and ultimately enhance the customers’ experience in interacting with the company.
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The Bioanalytical and Biomarker Sciences and Technologies (BST) department at Takeda is seeking a strong scientific and strategic leader to join the group as a clinical pathology expert and as the Head of the Pathology team supporting nonclinical, clinical and exploratory pathology/IHC biomarkers to achieve proof-of-mechanism/concept and inform decision-making for programs across therapeutic areas and modalities.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Maintain clear communication channels with key stakeholders and partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to ensure team resources are focused on critical asset support and related initiatives.
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Title: - Clinical-Scientific - Research Associate - We are looking for a Global Value & Evidence (V&E; Health Economics and Outcomes Research) Research Associate (RA) to join our Duchenne muscular dystrophy (DMD) gene therapy (GTx) team within Rare Disease (RD) Global Access and Value (GAV.
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The role will interact cross-functionally with members of Clinical Affairs, Data Management, Medical Affairs, Regulatory Affairs and Global Assay Development to ensure high quality of data and analysis results used in regulatory submissions.
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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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This individual will leverage their deep subject matter expertise in HEOR ( economics, epidemiology, statistics, and health services/clinical research) to teach colleagues how to design and deliver compelling HEOR evidence that improves lives and advances UCB’s strategy.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
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Scientific/Regulatory experience, particularly in the areas of procurement contracts for clinical studies, bioanalytical, and regulatory services is highly recommended. Reports to Director, Indirect Procurement.
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Demonstrated problem solving abilities in overseeing clinical evidence generation and clinical strategy development Advanced degree (MSc, MPH, PhD) in epidemiology, health services research, health outcomes research, biostatistics, data science, or related field.
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We are seeking a highly motivated scientific investigator with medical expertise in women’s health and/or infectious diseases, and a keen passion for designing and conducting innovative clinical research of new, often first-in-class, investigational products, many in the areas of reproductive health, infectious diseases and maternal health.
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We research, develop, and commercialize innovative digital health products and solutions by bringing together the full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research and validation, software development, AI / Gen AI, and regulatory.
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clinical research scientific affairs jobs Title: director Company: Biophase
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