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CCSI is partnering with Monroe County Department of Mental Health to hire a FACT Facilitator. This position is employed by CCSI and working on behalf of Monroe County. Coordinated Care Services Inc (CCSI) seeks a talented Family Access and Connection Team (FACT) Facilitator to contribute their expertise in providing essential business services to our provider organizations and customers.
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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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Direct the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.
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Perform other functions as required or requested to achieve the mission and goals of the CCSI. Serving as the CCSI-community partner liaison. The Civic Engagement Facilitator will shadow the FWS Community Service Program Facilitator and possible take over the FWS Facilitator position in due course.
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In collaboration with cross-functional stakeholders and Safety Review Committee, provides medical safety expertise in the development of or review of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, CCSI and other labeling documents, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, RSI, PASS, RMPs, REMS, RTDs, PASS, INDs, NDAs, BLAs, and CTAs.
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Contribute to the development and maintenance of the Company Core Safety Information (CCSI), propose edits, manage approval of amendments and contribute to safety summaries to support changes to the CCDS.
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Presents the CCSI to the labeling committee, contributes viewpoint to Company Core Data Sheet (CCDS) development, and reviews final CCDS and associated product labels. Actively leads the development and maintenance of the Company Core Safety Information (CCSI), proposes edits and manages approval of amendments.
$244,055 - $363,771 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Internal Contacts: Physicians, nursing staff, laboratory staff, pharmacy staff, office staff, other Business Office staff, etc., and staff at other CCSI facilities. CCSI Decatur - Decatur, IL.
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Prepare Company Core Safety Information (CCSI) for marketed and investigational products and the Company Core Data Sheet (CCDS), • Lead the determination of Adverse Reactions section of the product label; leads and support the preparation and review of other safety relevant sections of the label.
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Serves Pathways to Success eligible youth identified within CSS (Care Coordination) at Tier level CCSI (Intensive Care Coordination) in line with the policies of program. Serves Pathways to Success eligible youth identified within CSS (Care Coordination) at Tier level CCSI (Intensive Care Coordination) in line with the policies of program.
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Become familiar with the CCSi workflow processes and procedures to program and integrate equipment for a fully functional system. Become familiar with the CCSi workflow processes and procedures to program and integrate equipment for a fully functional system.
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ESSENTIAL DUTIES AND RESPONSIBILITIES:Leads and manages the Exelixis Labeling Working Group on the development, review, approval, and maintenance of the Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), USPI, EU SmPC and Rest of World (RoW) labeling.
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The candidate should hold or be willing to obtain the CCNP Enterprise, CISCO Security, and CCSI (Cisco Certified Systems Instructor) certifications within a year of hire. The candidate should hold or be willing to obtain the CCNP Enterprise, CISCO Security, and CCSI (Cisco Certified Systems Instructor) certifications within a year of hire.
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Bayside Plumbing Group, a subsidiary of CCSI (Complete Conversion Services, Inc) is currently hiring PLUMBERS for immediate starts! Bayside Plumbing Group, a subsidiary of CCSI (Complete Conversion Services, Inc) is currently hiring PLUMBERS for immediate starts.
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Plumbers wanted for immediate start, long-term work in Baltimore AND DC Metro areas! If you're looking to begin your journey with your "forever home", send your resume or brief description of job skills and salary history today, for immediate consideration.
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