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Engage regularly with colleagues within Corporate Communications (Social Media & Corporate Brand Storytelling); across External Affairs (Patient Engagement & Advocacy and Government Affairs); and cross-functionally in Employee Communications, Market Access, Medical Affairs, HEOR, Legal, Regulatory and Investor Relations to understand each functions objectives and drive an aligned approach to product communications and stakeholder message harmonization.
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Pharmaceutical industrial engineering knowledge (pharmaceutical design, development, manufacturing, and regulatory requirements) to optimize technical transfer from lab-scale to kilo lab/pilot plant production; Implement hazard operability analysis and risk assessment skills to draft batch records and safety reports; Analyze lab and production data using NMR instrumentation, data interpretation, Chromatography to ensure FDA regulatory compliance and maintain quality standards.
$93,000 - $120,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Understanding and familiarity with FDA and European regulatory requirements, guidelines. Organizational skills to coordinate multi-discipline projects Experience in participation in regulatory inspections a plus.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
RemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Support activities related to FDA compliance activities including GMP inspections, recalls and MDR's as assigned by the Director, Regulatory Affairs. + Provide guidance to CMSC Business Unit Managers and Engineering Managers in FDA regulatory submission preparation.
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Thorough understanding and working experience in drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Knowledge of FDA regulations and GCP/ICH guidelines a plus. Collaborate effectively with clinical, regulatory, CMC, non-clinical and other cross-functional team members to drive project delivery.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines.
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Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.
$21.65 an hourFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Complete all work in compliance with established cGMP, FDA, OSHA, USDA, EPA, ISO and Quality System regulations, as applicable, to assure output meets established quality and regulatory specifications.
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The Mfg Lab Technician performs laboratory activities in the manufacturing lab including Buffer and antibody manufacturing. AA/AS/BA/BS degree in biological science or biochemistry field OR. Facilitate in the development of documents, and update documents pertaining to lab procedures and product manufacturing to maintain cGMP and ISO compliance, and increase efficiency.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Experience in clinical research, familiarity with oncology protocols, clinical trials operations, GCP, NCI guidelines and federal regulations both FDA and HHS. Knowledge and familiarity of e-regulatory systems (Veeva), DocuSign, ImageNow and other applications used in the conduct of clinical research along with the relevant regulations.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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5 years of experience related to legal, regulatory compliance auditing, clinical research, or health information management services. Experience 2-5 Years' experience as a Clinical Research Associate, Clinical Research Coordinator, Clinical Research Nurse Coordinator and proven experience as an Lead Auditor.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Leads the planning, conduct and reporting of GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits, to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Identify new research opportunities beyond the OpCo or Platform core R&D efforts and support strategic IP management, as well as guidance around FDA and international regulatory matters, partnering with Platform and OpCo legal counsel.
ExpandApply NowActive JobUpdated 2 days ago
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