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Knowledge of the AMA, ACCME, PhRMA and FDA regulations associated with promotion and industry-supported scientific education activities. The key external stakeholders for this role may include organizationalleadershipC-Suite roles (CEO, CFO, CBO), VP Finance, VP Clinical Ops, Specialty Pharmacy, Outreach Coordinator, Infusion Site Directors / Enrollers,PatientAccess Managers, and the Reimbursement Teams.
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Communicate with class, USCG, FDA and any other required regulatory agency to resolve any regulatory or inspection issues raised during construction of the vessel. Bachelor’s degree in Marine Engineering, Mechanical Engineering, or Naval architecture, or Associate’s degree in Engineering Technology, Drafting or equivalent with 4 years’ experience in shipbuilding.
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Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc) Specimen management: obtain specimens for testing if applicable (including performing phlebotomy and anterior nares nasal swab collections), performs laboratory and screening tests, records results in EMR and reconciles with logs where appropriate, documents and reports findings to providers, performs all quality controls as per Point of Care Testing guidelines, prepares specimens for transport as necessary.
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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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3) Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
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The HVAC Production Engineer should expect to engage in regular field work in the shipyard's fabrication shops, dry docks, warehouse, and onboard vessels as part of the above activities. At least 2 years of experience with design or installation of HVAC systems and duct work.
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Successful candidates must be flexible regarding work locations: While the majority of our practices are within University City/Center City Philadelphia, we also have a large presence throughout the region, i.e. (i.e. Delaware County, Chester County, Montgomery County, Bucks County, Philadelphia County, and New Jersey.
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Keeps current on knowledge of Sterile Processing standards, regulations, protocols, products, and equipment according to AAMI, AORN, Commonwealth of PA Department of Health, Joint Commission, FDA, and CDC.
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Other / Regulatory: Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and readily adopts new processes and engages in practice operation changes.
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Extensive knowledge of GLP, GCP, ICH and FDA biologics regulations. Our name - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer.
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In-depth knowledge of U.S./Canada import regulations, including but not limited to C-TPAT, ISA, Drawback, Recon, Valuation, Classification mgt, Broker management, Free Trade Agreements (FTAs), Food & Drug (FDA) and other Partner Agencies (PGAs), risk assessment, Country of Origin (COO) determination and marking, First Sale, and Free Trade Zones (FTZs) Strong analytical skills with the ability to interpret complex regulatory requirements.
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Working to drive day to day research activities and supporting multiple components of the clinical trial, while adhering with FDA, IRB, Pennsylvania, and related regulations. The Program for Maternal Health Equity (PMHE) at the Center for Urban Bioethics (CUB) is seeking a Research Associate to join our team.
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Coordinates quality improvement and assurance activities in the Blood Bank to ensure safe patient care, compliance with internal policies and procedures, and external (FDA, CAP/AABB, Joint Commission, FACT, NJDOH) regulatory compliance.
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Certification or eligibility as Medical Laboratory Scientist (MLS) or Specialist certification through American Society of Clinical Pathology (ASCP) or equivalent preferred. Blood Bank: 3-5 years of relevant experience in immunohematologic testing and Blood Bank quality systems with progressive increase in supervisory responsibilities.
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Responsible for overall management of the trial(s) to ensure compliance with study protocol, FDA, NIH and IRB policies. Complete annual reports to Institutional Review Board, CTSA, FDA and other regulatory agencies.
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fda job in Philadelphia, PA
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