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ATEC’s Scientific Affairs team is responsible for regulatory, testing, and research activities in support of the company’s initiatives. The Clinical Research function, as a sub-function of Scientific Affairs, includes planning, coordinating, and overseeing the successful execution of preclinical and clinical research studies and large-scale data collection efforts in partnership with our surgical practice partners.
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This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
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Regulatory Compliance Knowledge : Well versed in regulatory requirement sand guidelines related to DME billing including Medicare regulations. The Senior DME billing code compliance and appeals specialist will play a crucial role in ensuring that our DME product complies with the billing codes and regulations set by Medicare and all federally funded payers.
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Work with the Provost & Dean of Faculty, Program Director, and Country Coordinators, to ensure that any academic, administrative and student affairs associated with the program are resolved. Take appropriate measures to protect the health and safety of students in partnership with SIT Student Affairs and local staff.
$28,000 - $32,000ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up.
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This role, Network Compliance Auditor (FSR) Nurse, performs all aspects of a Facility Site Review (FSR), using regulatory requirements, to test, monitor, document and report the overall level of compliance of the First Tier, Downstream and related entities (FDR) to ensure compliance with all applicable requirements; SCAN, Federal, State and National Committee for Quality Assurance (NCQA) requirements.
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Lead the Company’s ESG data collection, analysis and reporting efforts from start to finish, adhering to best practices aligned with relevant regulatory reporting requirements. As our in-house Sustainability Data Manager, you'll play a pivotal role in advancing Topgolf Callaway Brands' Global Sustainability Program.
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Your responsibilities encompass refining ESG data collection, analysis, consolidation, and reporting processes across our brands. Detailed knowledge of ESG data and reporting frameworks (i.e. GRI, TCFD, SASB, CDP, etc.
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Provide strategic guidance to clients engaged in regulatory processes with the FERC. Strong understanding of regulatory compliance and permitting programs at the federal, state, and local levels.
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The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.
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Senior Calibration Technician is the highest-level technician position within Transcat with a minimum of six (6) years commercial calibration experience preferred.
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ATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.
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Maintain current knowledge and expertise, within the CMC regulatory environment (ICH, FDA, EMA, PMDA, etc.) Author and compile drug product CMC sections of US FDA and Ex-US regulatory applications, and submissions of IND and CTA, including amendments and annual updates.
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Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements, including electronic data submissions and CDISC implementation. Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements, including electronic data submissions and CDISC implementation.
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The Flow Cytometry Supervisor role involves leading daily operations within the department, ensuring regulatory compliance, and managing technical challenges. At least one year in a supervisory capacity with a California State Clinical Laboratory Scientist License (CLS.
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regulatory affairs jobs Title: sr regulatory affairs associate in Carlsbad, CA
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