- Stanford Health Care (Palo Alto, CA)
- …has been in treating B-cell lymphoma, where CAR T-cell therapy has become an FDA -approved standard of care. We are now expanding our efforts to develop cell ... Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -...not FDA -approved or are used for a non- FDA - approved indication (off-label use) require a patient-specific order… more
- Dentsply Sirona (York, PA)
- …the in-country representative when filing for certain jurisdictions (eg US FDA ). + Collaborates with global counterparts and other in-country representatives, Safety ... and submits high-quality, timely reports to health authorities (eg, FDA , EMA, MHRA, TGA, Health Canada) in compliance with...Deep understanding and application of global reporting requirements (eg, FDA 21 CFR Part 803, EU MDR, ISO 13485,… more
- Perdue Farms, Inc. (Accomac, VA)
- …interface with internal, external, customer and regulatory (USDA and/or FDA where applicable) inspectors regarding sanitation related non-conformance reports and ... by following and ensuring strict enforcement of Perdue Farms Standards, USDA, FSIS, FDA , GFSI, OSHA and customer requirements. 18. Leads or participates in the… more
- Terumo Neuro (Aliso Viejo, CA)
- …execution and operational excellence in accordance with ICH Good Clinical Practices, FDA regulations, guidance documents, and company SOPs. Provide oversight of site ... protocol, GCP, company SOPs, and all applicable regulations (eg, FDA ). + Understand, read, prepare, and deploy study documentation...4 weeks a month (75%-100%) 5. Strong knowledge of FDA regulations for clinical trials and clinical procedures. 6.… more
- Abbott (Casa Grande, AZ)
- …and finished products, while monitoring the environment to maintain compliance with FDA , GMP, and industry standards. If you thrive in a collaborative, ... tasks to deliver accurate results efficiently while maintaining compliance with FDA , GMP, and regulatory standards for infant formula and nutritional products.… more
- ManpowerGroup (Zeeland, MI)
- …within budget, and in compliance with food safety, quality, and cGMP/ FDA standards. The Project Engineer collaborates closely with other engineers, contractors, ... processes. + Manage documentation in compliance with cGMP and FDA standards, including presentations, reports, drawings, specifications, and workflow forms.… more
- Boehringer Ingelheim (Orlando, FL)
- …System. + Performs all Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When ... Previous account management experience. + Various regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company...and knowledge of territory. + Regulations such as EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company… more
- Biomat USA, Inc. (Kannapolis, NC)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- Sanofi Group (Cambridge, MA)
- …The intern will engage in literature review, case study analysis of an FDA or EMA-approved gene therapy, and exploration of advanced statistical techniques relevant ... an in-depth case study analysis of a gene therapy approved by the FDA or EMA, including trial design, statistical strategy, and regulatory feedback. + Explore… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. +… more