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Regularly contribute to external efforts such as International Society of Quality-of-Life Research (ISOQOL), International Society of Pharmacoeconomics & Outcomes Research (ISPOR), CPATH, DIA, FDA initiatives, National Institute of Health (NIH) initiatives etc.
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You will work directly with our R&D and Compliance Manager on new product development, herbal formulation,clinical research, claim substantiation, educational content, and DSHEA, FDA, and FTC compliance regulations.
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In depth knowledge of regulatory and scientific guidance including FDA & EMA guidances, FDA qualification documentation, ISPOR Task Force papers, etc. Lead regulatory EMA/FDA dossier development.
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As a key stakeholder, the Director represents the investigator/research team when working with internal regulatory groups such as the IRB, OCR, Clinical Trials Scientific Review and Monitoring Committee (CTSRMC), Data Safety and Monitoring Committee (DSMC), and DOCM, as well as external entities including pharmaceutical companies, contract research organizations, the FDA, and the NCI's National Clinical Trials Network (NCTN) groups.
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Perform cochlear implant evaluation, activation and long-term post-operative cochlear implant care for FDA approved cochlear implant devices. Perform cochlear implant evaluation, activation and long-term post-operative cochlear implant care for FDA approved cochlear implant devices.
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Agri-food industry technology and processes, project or product engineering in food or dairy processing plant, knowledge of main dairy process equipment (HTST, separator, membrane systems, mechanical, electrical and control systems associated) and FDA and USDA regulations.
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Strong knowledge of general food safety programs and policies, to include government regulations, OSHA, FDA, USDA, AIB, HACCP, GMP, TTB and Allergen Program. Assists the QA Manager, Continuous Improvement Manager, Food Safety Officer, Plant Chemist and R&D Department to obtain FSSC Certification and excellent audit ratings.
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This role will include activities prior to shipment as well as transactional entry activities aligned with US Customs, Census, FDA, USDA, FWS, CDC, and other Partner Government Agencies (PGA) requirements.
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ICON Patient Centred Outcomes (PCO) is part of ICON plc, a leading global Clinical Research Organization headquartered in Dublin, Ireland. Masters degree in outcomes research or related discipline, PhD strongly preferred.
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Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC). The Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes' biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others.
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Provide legal counsel to Abbott’s Electrophysiology team on compliance, risk management, and other legal issues in the context of federal and state regulatory requirements, including those relevant to sales and marketing of products to health care professionals and reimbursement by government programs areas, for example, fraud and abuse (Anti-Kickback Statute, False Claims Act), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act.
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The Senior Project Engineering manager reports directly to the Plant Director and has one direct report, the junior project engineer. Senior Project Engineering Manager (food or dairy)Our client is a multinational multicontinent dairy manufacturer.
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We are helping them find a talented Senior Project Engineering Manager that will take the leadership in that direction. Once approved, this person's role is to develop the project timeline coordinating with equipment vendors and other contractors to install the food processing and packaging lines and manage the entire process.
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In-depth knowledge and experience with GLP and/or GCP regulations and industry standards (EPA, OECD, FDA, EU guidance) HistoWiz has over 1,000 paying customers globally from top academic institutions (e.g. MSKCC, Harvard, Stanford, HHMI) and pharmaceutical companies (e.g. CRISPR, Johnson & Johnson, Regeneron.
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Support cochlear implant recipient needs including assistive device and rehabilitation recommendations. Ability to obtain and interpret objective measures of cochlear implant function including intraoperative measurements.
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