- Merck (West Point, PA)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- Sumitomo Pharma (Harrisburg, PA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Fujifilm (Harrisburg, PA)
- …States. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... changes, post-market surveillance, and product obsolescence. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a… more
- Sanofi Group (Pittsburgh, PA)
- …role, the TEM will assist patients and caregivers with accessing Sanofi's FDA -approved 14-day T1D infusion therapy. The CE provides disease and product information ... also ensure full compliance with all corporate and industry policies and legal and regulatory requirements, for all field activities and report all AEs. This is a… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... well as clinical performance and utility of assays. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more
- Sanofi Group (Swiftwater, PA)
- …in accordance with current good manufacturing practices (cGMP) for all relevant regulatory agencies (eg FDA ). Positions within production facilities may change ... as needed. **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the...between 1 to 50 pounds per health center + Regulatory audit understanding and awareness **About You** + You… more
- Sanofi Group (Swiftwater, PA)
- …in accordance with current good manufacturing practices (cGMP) for all relevant regulatory agencies (eg FDA ). Positions within production facilities may change ... Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the...between 1 to 50 pounds per health center + Regulatory audit understanding and awareness **About You** **Basic Qualifications:**… more
- Penn Medicine (Yardley, PA)
- … Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.) ... to emergency/code situations. + CCA MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Penn Medicine (Exton, PA)
- …/ Regulatory + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... + Clinical Care Associates (CCA) MAs - if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- University of Pennsylvania (Philadelphia, PA)
- …The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement ... be expected to adhere to all University of Pennsylvania, FDA , and GCP guidelines. The CRC-B/C will be responsible...of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance… more