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Knowledge of Fixed Income regulatory reporting, including TRACE. Experience working with mortgage products, including TBA, Pools and CMO. Hands-on knowledge of the Relational and/or No-SQL (Oracle, Sybase, MongoDB, etc) is a plus.
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While providing executive leadership, the Regional CMO demonstrates in-depth knowledge and expertise for, hospital operations and compliance with regulatory bodies, clinical documentation, and end-to-end revenue cycle management.
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Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
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To ensure an effective implementation and support of the accreditation and risk management plan/program, the specialist works in collaboration with local leadership (President, Chief Operating Officer (COO), Chief Nursing Officer (CNO), and Chief Medical Officer (CMO.
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Responsible for building a pharmacovigilance infrastructure together with the CMO, and in collaboration with clinical, biostatics, regulatory, and other relevant functions. Advanced knowledge of Pharmacovigilance regulations and documentation requirements: in depth knowledge of GCP, clinical safety documentation and reporting of adverse events, regulatory requirements, pharmacovigilance methodology.
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The Senior Clinical Director, working closely with the CMO and COO,is responsible for developing and facilitating the quality assurance,risk management, regulatory compliance, and operational performanceimprovement activities for all clinical services.
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Your role will assist with Ongoing Physician Practice Evaluation (OPPE) and Focus Physician Practice Evaluation (FPPE) at the direction of VPQ and Market Quality Director, CMO and Chief of Staff.
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Effectively communicate (verbally and in writing) important results of medical safety and benefit/risk management evaluations when necessary, to the GMS Leadership Team, CMO, and the Pharmaceuticals Medical Safety Council (MSC.
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Partnering with the CMO, you will be key in leading the clinical development team in developing, sharing and embedding best practice ways of working across all the GPTs and clinical teams covering program design, delivery, reporting and in support of regulatory interactions and commercialization of Rocket’s exciting gene therapy portfolio to deliver highly differentiated transformative medicines.
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Collaborate with the Regional Director, Sr. Admin of CHS, Grant Manager, Chief Medical Officer (CMO) and QI Team to establish quality goals, objectives, and strategies for the Ryan White Program performance and outcomes to ensure effectiveness and efficiency in accordance with HRSA and Cooperative Health regulatory guidelines.
$80,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Remain well versed in regulatory requirements to assure appropriate design and execution of vaccine manufacture and toxicology studies via services of CMO and CROs. Knowledge and skills in chemistry and biochemistry (e.g. medicinal chemistry, bioanalytical chemistry, protein chemistry, protein expression.
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Responsible for clinical leadership in the BHS division, and with the CMO, provides advice/counsel the CEO, Board of Directors, and Senior Leadership on clinical, program, and regulatory matters.
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Broad understanding of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization) in oncology.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Head up the development team starting at the time of CTA/IND or proof of concept depending on the program, including all functions: clinical, regulatory, biostatistics, program management, clinical operations, tech ops/CMC, clinical pharmacology, research, and preclinical development, to design and execute clinical development plans for assigned projects.
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Works closely with pharmacovigilance vendor and manages all activities related to pharmacovigilance for clinical trials in compliance with regulatory requirements. Oversee and guide remediation of pharmacovigilance deficiencies cited during regulatory or internal audits.
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