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Document methodologies, processes, and results comprehensively for reference and regulatory compliance. Familiarity with clinical trial data and CDISC standards. 3 years of proven experience in SAS programming including BASE SAS, SAS/STAT, SAS/MACRO, and SAS/GRAPH with a focus on integrated analysis.
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Completes charting in a thorough and timely manner Adequately manages patient flow in the Emergency Department Performs procedures as allowed by state law and under the direction of the supervising or collaborating physician Works within legal, regulatory, and ethical practice standards Actively participates in Emergency Department staff meetings and risk management education Completes required courses, i.e. HIPAA, EMTALA and other CME /CEU requirements.
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The Team Member will work closely with colleagues to prepare fresh and hot food, deliver 5-star guest service, clean and maintain the restaurant, and conduct other duties assigned by the Restaurant Management Team. This role manages payments responsibly, adheres to food service standards, and ensures cleanliness of all aspects of the restaurant in compliance with all policies, procedures, and regulatory requirements.
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As part of the Consulting leadership team, the Managing Director - Medical Affairs will contribute to setting business direction, strategy, and priorities and take ownership for driving the overall growth and scalability of the Medical Affairs consulting business.
$250,000 - $300,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Knowledge of the regulatory requirements and procedures for the development and filing of compliant contract forms associated with group annuity business. Support regulatory filings, using primarily the SERFF (including Interstate Insurance Compact) electronic filing system.
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Coordinate the preparation of regulatory reporting. Coordinate the preparation of regulatory reporting. iBuy is a rapidly expanding retail and wholesale distributor, specializing in consumer electronics, kitchenware, apparel, and more, but always looking to develop new categories and expand our reach.
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He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Client locations or contract manufacturing organizations (CMOs), or alliance partners.
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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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8+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC. Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Technical knowledge in maintenance/metrology management, broad understanding of facilities management, cGMP compliance, EHS and regulatory standards (e.g. EPA, OSHA, and DEA) Provides input in the development & execution strategy of calibrations (Cals), preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory standards.
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Know and comply to corporate policies, regulatory standards (SOX), internal business processes (PCI) and procedures while processing work and meeting/exceeding service performance and quality standards.
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Responsible for and manage all regulatory compliance (DOT, OSHA, BIC, DSNY, NYDEC/ NJDEP, etc.) Serve as a regulatory resource for the market area. Bachelor's degree in relevant field (Safety, Industrial Hygiene, Engineering, Environmental Science) or equivalent combination of education and technical experience.
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Acts as primary interface with national consumer affairs and the technical hotline in relation to customer requests, Better Business Bureau (BBB) arbitration, and Lemon Law cases. Prior to arbitration, works with NNA consumer affairs department to assess situations and identify applicable resolutions for NNA and the customer.
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Candidates must be able to demonstrate a robust understanding of pharmaceutical business transactions and regulatory issues, intellectual property law, licensing, and mergers and acquisitions. Support Senior Vice President – Legal Affairs in other tasks, including review and negotiation of lender and other strategic agreements.
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Work with cross-functional project teams (Product Development, Implementation & Support, Research & Implementation, Safety, Regulatory, Legal, Marketing) to review concepts/claims trackers and develop robust clinical programs to support Personal Care, Skin Health products.
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regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Bridgewater, NJ
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