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Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical and research to support and impact development decisions.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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We are seeking a highly motivated, experienced, and passionate individual to join our team as Pharmacovigilance Quality and Compliance Pharmacovigilance Coordinator at Ardelyx Inc. As a subject matter expert, you will play a pivotal role in ensuring the adherence of our pharmacovigilance activities to regulatory requirements, industry standards, company policies, and global regulations.
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QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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This role collaborates cross-functionally with key cross-functional partners including other GMA functions, Clinical Development/Operations, Regulatory Affairs, Corporate Communications/IR, Legal, Market Access and Commercial, and Research.
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Oversee quality assurance activities to ensure the integrity, accuracy, and compliance of clinical trial data within Veeva Vault applications, in accordance with regulatory requirements (e.g., FDA guidelines, GCP standards.
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Regulatory Toxicology & Safety Pharmacology is a global department within the Clinical Pharmacology and Safety Sciences (CPSS) function; we’re looking to recruit a talented and experienced reproductive toxicologist to join our reproductive toxicology team.
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Ensure robustness, reproducibility, and regulatory compliance of biomarker assays and data generated across clinical studies. Strong knowledge of biomarker technologies and methodologies, including genomics, proteomics, imaging, and flow cytometry, as applied to clinical research.
$150,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases.
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Experience at clinical-stage biotech or commercial-stage biotech/biopharmaceutical/pharmaceutical company(ies) is a plus. The ideal candidate will have strong law firm experience in securities laws, NASDAQ rules and regulations, corporate governance, and transactions; experience at biotech, biopharmaceutical or pharmaceutical company(ies) is a plus.
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3 years as a Clinical Trial Scientist or comparable role Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 - 3; ideally paired with experience in Oncology / Immuno-Oncology Good knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institution.
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Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.
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Support the development, implementation and maintenance of policies and procedures that enable the firm to remain in compliance with regulatory requirements. Stay up to date on relevant regulatory trends and assess their impact on our businesses and communicate and reflect any changes accurately in the marketing compliance program to ensure MIM maintains a robust marketing compliance program.
$58,875 - $98,125 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
clinical research pharmaceutical company regulatory compliance jobs Company: Wirb Copernicus Group in Waltham, MA
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