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Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management using the support and input of GRO, MCs, CROs and/or alliance partners.
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Lead NCATS Cybersecurity compliance efforts to follow the Risk Management Framework (RMF). · Ensure on time delivery of task order deliverables for cybersecurity compliance. Axle is seeking a Cybersecurity Compliance Lead to join our vibrant team at the National Institutes of Health (NIH) supporting the National Center for Advancing Translational Sciences located in Rockville, MD.
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The Cybersecurity Compliance Lead will support day-to-day and project-based security activities, POA&M remediations, vulnerabilities impact, and remediation process for the on-premises and cloud environments.
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15 years of experience in drinking water treatment with at least 5 years in water quality and treatment (water quality analysis, treatment evaluations, process design, regulatory compliance assessments, distribution water quality analysis, etc.
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Provide regulatory leadership on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives.
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Conducts regulatory research to maintain expertise and support compliance training and education related to Federal, State and local laws and regulations, enforcement initiatives, third party coding, billing and claims submission, financial arrangements with physicians, conflicts of interest and internal policies and procedures.
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As a not-for-profit entity, FINRA (Financial Industry Regulatory Authority) operates under the oversight of the SEC and sits at the nexus of broker-dealers, policymakers and investors. Reviews a full workload consisting of communications with the public including retail and institutional sales material submitted by firms pursuant to the filings review program, provides written comments on whether this material complies with applicable rules and provides revisions necessary to bring the sales material into compliance.
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Partner with the GSP and other functional specialists to lead the safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA). You will facilitate collaboration with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
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Minimum of fifteen (15) years of pharmaceutical experience with ten (10) years of regulatory affairs experience including two to three (2-3) years in Commercial Regulatory experience working with biologics, preferably Cell therapy products.
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The working environment is divided between field work (serving civil process papers, transporting prisoners and citizens, returning prisoners from out of County/State and maintaining custody of prisoners in a small detention setting) and time spent in a courtroom providing prisoner and courtroom security.
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This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data.
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Demonstrated knowledge of and experience applying the principles and methods of computer security and compliance programs as required by the Federal Information Security Management Act (FISMA) and National Institute of Technology and Standards (NIST) security policy, standards, procedures and guidelines.
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Westat is seeking a Legal Compliance Specialist to work closely with our in-house counsel in providing day-to-day consultation on legal compliance issues together with involvement in small- and large-scale corporate compliance/best practices initiatives.
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Knowledge of regulatory compliance standards (e.g., GDPR, HIPAA, PCI DSS). Benefits: 401(k) 401(k) matching Competitive salary Dental insurance Health insurance Paid time off Training & development Tuition assistance Vision insurance SDA Solutions LLC is seeking a Senior Cloud Security Architect to join our team and lead the design, documentation, and implementation of our cloud security strategy.
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Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
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regulatory compliance courtroom jobs in Gaithersburg, MD
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