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Familiar with submissions to the FDA/regulatory entities. Familiar with submissions to the FDA/regulatory entities. Supporting the Head of Biostatistics in Oncology studies. Hands on experience with adaptive design experience.
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Knowledge and compliance to cGMP, FDA, Data Integrity, and other biopharmaceutical regulatory requirements preferred. Work with bacteriophages and associated analytical assays such as plaque assay, PCR, ELISA, gel electrophoresis and etc.
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The Apheresis Quality Specialist is a member of the Apheresis Core Facility at Kraft Family Blood Donor Center at BWH with accountability for programmatic quality oversight as directed of the Apheresis Unit, to ensure compliance with all applicable regulatory agencies (FDA, FACT, AABB, etc.
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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.
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Regulatory and laboratory experience in animal health technology including FDA/IMS milk testing, serology, bacteriology, parasitology and/or mycology preferred along with Certification in the examination of dairy products.
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Working knowledge of healthcare regulatory advice (e.g. Anti-kickback law, FCA, HIPAA, government price reporting, government contracting, antitrust) and experience in the manufacturer space (e.g. FDA, market access, supply chain channel strategy.
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One year of experience auditing laboratory documentation in a regulated environment (i.e. FDA, GLP, etc. 1 year of experience with FDA regulations (cGMP, GDPs, adherence to USP, BP, etc.
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In-depth knowledge of data management, including interpretation and implementation of FDA regulations/lCH guidelines, and GCP is required. Will work closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and expectations, and budget.
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Knowledge of other regulatory, compliance, and legal issues related to health care including (1) FDA Regulations (and other international equivalents); (2) ICH-GxP requirements; (3) global medical device and in vitro diagnostic registration requirements; (4) transparency laws; and (5) human biological specimen regulations.
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Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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Demonstrated knowledge of railway engineering regulatory requirements (i.e., AAR, AREMA, FTA, FDA, and FRA). Directs the strict implementation of maintenance alerts, FRA and FDA regulatory requirements, supplier maintenance instructions and SMPs.
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Participates in regulatory inspections and company audits including FDA/MHRA/EMA PV inspections; assists with prepares responses to audit findings that concern the DSPV department. Job Title: Senior Drug Safety Specialist.
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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF). Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations.
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Minimum 7 years of experience in delivering an effective compliance and ethics program and related legal work, including exposure to corporate compliance best practices, standards of business conduct, anti-bribery and corruption, privacy, and FDA and related healthcare regulations, with a portion of this time spent in a law firm or within a governmental agency.
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Regulatory, Legal, and ComplianceMaintains knowledge of applicable standards of CLIA, NYS CLEP, TJC, FDA, OSHA. Composes and maintains policies, procedures, maintenance records, records of orientation, training, competency assessment, quality control, and quality management as needed for reliable operations and regulatory compliance.
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