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The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
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Must have experience in designing, identifying, managing, and updating, appropriate hardware and software for networking, programming, cloud computing, and cyber security instructional space; experience in designing and delivering courses in digital forensics, ethical hacking, cloud computing, risk management, and regulatory compliance preferred; Certified Information Systems Security Professional industry certification preferred.
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Settles claims by determining insurance carrier’s liability, client’s instructions and authority levels required by obtaining demands and making offers to claimants, issuing settlement checks, making filings with regulatory agencies, disposing of salvage, pursuing subrogation when appropriate.
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Experience supporting client ROE proposals in regulatory proceedings using models such as single and multi-stage DCF, Risk Premium, and CAPM.Excellent presentation skills and writing ability.
$160,000 - $200,000 a yearExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Fundamental reading, writing, math and computer /POS skills are required; must meet the minimal criteria in background check. Focuses on developing a people and guest-centric culture that consistently delivers excellent guest service and food quality while ensuring compliance with policies, procedures, and regulatory requirements.
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Our teams apply eDiscovery leading practices and leverage analytics technology, as well as traditional legal research and writing, to assist government attorneys and agency staff through the litigation or information request process.
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4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D. 2 years relevant industry experience preferred.
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These duties include providing oversight and general support of the compliance processes including, but not limited to, conducting supplier audits, authoring annual product review reports, conducting internal audits, supporting client audits, supporting external regulatory audits (e.g. FDA, EU), writing effective audit reports, following up on audit responses and commitments (both internal and external), and oversight and enforcement of GMP regulations.
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Security environments including: operational knowledge of malware detection and response methodologies, operating system hardening, incident response, policy writing, regulatory compliance, data classification, vulnerability management, best practices.
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Experience developing, working with, and interpreting complex regulatory and financial models. Experience testifying as an expert witness before regulatory commissions. 10+ years of professional experience in an electric and/or natural gas rate design role.
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As one of the world’s leading law firms, we serve a broad range of clients with market-leading practices in private equity, M&A and other complex corporate transactions; investment fund formation and management; restructurings; high-stakes litigation and trials; and government, regulatory and internal investigations.
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The candidate will support renewable energy technology, policy, market, financing, and regulatory projects through data collection and analysis, literature reviews, industry interviews, writing, and spreadsheet analysis.
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Demonstrated experience and proficiency in ERP security, programming language, writing computer scripts, or computer forensics. Enterprise Application and ERP Solution Security Analyst , you will provide technical expertise for security access management, regulatory compliance, security policy, and application-level security compliance.
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The Structural Engineer will draft and analyze temporary work designs for assigned construction projects to ensure constructability with contract documents, specifications and regulatory requirements.
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At least 1 year of experience in Biotech manufacturing or technical writing experienceManufacturing process knowledge preferred. Manage eBR review comments, answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the minimal aid of document owners, coordinate delivery timelines for eBR support documents for approval of batch recordsAssist with testing and validation of eBRs, operations and electronic work instructions.
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writing regulatory jobs
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