- Sumitomo Pharma (Tallahassee, FL)
- …and international travel **Key Core Competencies** + Knowledge and understanding of FDA , GCP, and ICH regulations and guidance + Thorough and up-to-date knowledge ... of therapeutic area including trends, advances, understanding of currently available therapies and competitive clinical landscape + Experience in conducting global clinical trials in both early- and late-stage clinical development, especially protocol… more
- HCA Healthcare (Sanford, FL)
- …care, acute inpatient medical rehabilitation, and complete imaging services. + US FDA -accredited with the Mammography Quality Standards Act and Program + Accredited ... for CT, mammography, MRI, nuclear medicine, and ultrasound by the American College of Radiology + CARF-accredited acute inpatient medical rehabilitation center + Joint Commission-accredited Advanced Primary Stroke Center Sanford, FL is a rapidly growing… more
- HCA Healthcare (Sanford, FL)
- …care, acute inpatient medical rehabilitation, and complete imaging services. + US FDA -accredited with the Mammography Quality Standards Act and Program + Accredited ... for CT, mammography, MRI, nuclear medicine, and ultrasound by the American College of Radiology + CARF-accredited acute inpatient medical rehabilitation center + Joint Commission-accredited Advanced Primary Stroke Center Sanford, FL is a rapidly growing… more
- United Therapeutics (Tallahassee, FL)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …MW processes, best practices, and process improvements. + Reviews new ICH and FDA guidelines regarding MW, evaluates their impact on the organization and makes ... recommendations on the need to develop and/or enhance SOPs and work processes. + Leads or supports process or innovation initiatives within the MW team and/or represents MW in other departmental innovation initiatives. + Provides relevant and timely project… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required. + ... Prepare and submit all federal, state and local permits in a timely manner. + Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are… more
- Biomat USA, Inc. (Boca Raton, FL)
- …understanding of the anti-D specialty plasma program and understands the FDA regulations/ requirements and helps to maintatin compliance with established SOPs ... for the processing of whole blood, frozen red blood cells, and deglycerolized red blood cells. + Develop understanding of other specialty plasma programs and the support provided by the laboratory for these. + Act as a reference in case of problems with… more
- Kelly Services (Clearwater, FL)
- …product meets all acceptable criteria per SOPs + Following all FDA /CGMP regulations regarding traceability and safety procedures + Supporting, encouraging, and ... participating in team-related activities + Assisting in training manufacturing associates + Reporting unusual conditions and problems to supervisor and manufacturing lead + Practicing good housekeeping **This job might be an outstanding fit if you:** + Have a… more
- Fujifilm (Tallahassee, FL)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** + Bachelor's degree in biomedical… more
- Fujifilm (Tallahassee, FL)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations and standards + Familiarity with ITIL Support Process Model and support levels + Stays up to date on the latest Synapse and IT products + Self-directed with excellent management skills + Demonstrated ability to transfer… more
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