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Knowledge of FDA regulatory requirements is required. Maintain regulatory files throughout the protocol lifecycle and ensure all study related documents are updated per Human Subjects Protection Branch and Institutional Review Board requirements.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Engage and may lead CMC Subject Matter Expert activities and typically have deep/specialized area of expertise, both internally (for increased compliance, harmonization and efficiency) and externally (external advocacy and shaping the regulatory environment.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The role of an IT Compliance Manager is pivotal in ensuring that our organization adheres to regulatory standards, mitigates risks, and maintains robust governance processes. As an integral part of our team, you will collaborate closely with IT Organization, internal audit staff and external service providers to drive excellence in technology, cybersecurity, and regulatory audits.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Broad knowledge of trade compliance laws and regulations applicable to the Company’s business, including ITAR, EAR, and OFAC sanctions regulations. EchoStar has an exciting opportunity for a Trade Compliance Corporate Counsel.
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We are adding a Lead SOC Analyst to our high performing team supporting our FDA Contract. Be lead for shift (supervising Tier 1s), interface with FDA Watch Officers. Analyze and respond to security events and incidents from SIEM,Firewall (FW), Intrusion Detection Systems (IDS), Intrusion Prevention Systems (IPS), Antivirus (AV), Network Access Control (NAC) and other client data sources.
$106,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Conducting and managing quality control reviews for Reasonable Accommodation requests to ensure adherence to Fair Housing laws, performing quality control reviews for Davis Bacon Act compliance, and assisting in the development and auditing of the other Quality Control processes are also within their responsibilities.
$80,335 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Oversees compliance with the organizations anti-trafficking policy. Institutes and maintains an effective ethics compliance communication program for the organization, including promoting: (a) use of the anonymous reporting hotline; (b) awareness of Standards of Conduct; and (c) understanding of policies and procedures.
$300,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Medical Director works with a cross-functional team to ensure the medical/clinical integrity and quality of all drug, biological product, and medical device studies by Unither Bioengineering are conducted per all applicable regulations and in compliance with internationally accepted Good Clinical Practices (GCP) and that commercial, clinical, and research activities conducted by Lung Bioengineering is consistent with industry best practices.
Full-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Collaborate across Process Development, Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Finance and Technical Development for successful commercialization of late-stage portfolio.
$328,900 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Model Risk Management: Responsible for managing the Divisions model risk management program (hedging model and mortgage servicing rights valuation model) in accordance with regulatory requirements and corporate policy as determined by Enterprise Risk Management.
$225,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Review project plans, Construction Security Plans, construction blueprints, architectural drawings, and technical data to determine compliance with relevant Department of State (DoS) and Intelligence Community (IC) standards.
$196,225 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Security and compliance: Knowledge of DevSecOps principles and experience integrating security controls and compliance checks into IaC. The equal employment opportunity policy of the GEICO Companies provides for a fair and equal employment opportunity for all associates and job applicants regardless of race, color, religious creed, national origin, ancestry, age, gender, pregnancy, sexual orientation, gender identity, marital status, familial status, disability or genetic information, in compliance with applicable federal, state and local law.
$300,500Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Prepare high quality IT Compliance deliverables including planning memo, drafts of audit issues, IT Compliance periodic reports, and presentations. Reporting directly to the Sr. Director of Cybersecurity & Compliance, you will play a critical role in enhancing our operational effectiveness.
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The Scientist will provide subject-matter expertise in a range of translational research strategies, immunoassay techniques, assay development, and fit-for-purpose Regulatory approach. Experience and aptitude for development and implementation of translational or biomarker strategies, preparation of scientific publications, presentations, and regulatory documents is a plus.
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We are looking for a Compliance Director with at least twelve years’ prior experience working in a leadership role in the health care industry, and strong familiarity with regulatory laws and compliance, including fraud, waste and abuse.
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fda regulatory compliance jobs in Rockville, MD
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