- UPMC (Pittsburgh, PA)
- …+ Maintain laboratory Drug Master Files that will be submitted to the FDA . Assist to create and maintain the Laboratory Disaster Plan. Monitor annual laboratory ... as appropriate on various committees related to safety and regulatory compliance as requested and needed. + Research regulatory requirements, prepare and… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & ... abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding...to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company… more
- Merck (West Point, PA)
- …regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies ( FDA , EMA, JNDA, TGA). + **Leadership:** Establish, manage and support CMC ... teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion,...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los… more
- Sumitomo Pharma (Harrisburg, PA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... (written, verbal, electronic, etc.) that an employee encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable… more
- UPMC (Farrell, PA)
- …provides study development and implementation assistance, submissions to the FDA , IRB processing, patient recruitment, study coordination, study-specific training, ... strategies to manage the care of patients participating in research, ensuring compliance with protocol procedures, assessments, and reporting requirements as well as… more
- Lilly (Philadelphia, PA)
- …This position requires a strong technical background in analytical methods and compliance with CGMP regulations, ensuring the integrity of products from preclinical ... CMC + Manage day-to-day operations of AD/QC labs and AD/QC team and ensure compliance with cGMP regulations, SOPs and HSE procedures. Ensure readiness of AD/QC labs… more
- Evolent (Harrisburg, PA)
- …prior authorization and financial scope reconciliations, ensuring accuracy and compliance . + Conduct ongoing surveillance of coding updates from authoritative ... for Medicare & Medicaid Services (CMS), Food and Drug Administration ( FDA ), and various prior authorization lists, facilitating timely decision-making for clinical… more
- Biomat USA, Inc. (Williamsport, PA)
- …in compliance with local/state/federal codes and regulations, including OSHA, FDA , Fire, Building/Safety, etc. + Track and evaluate critical data to recommend ... requires an understanding of project requirements to ensure projects are in compliance with cGMP design, applicable codes, and environmental laws, rules, and… more
- ThermoFisher Scientific (Collegeville, PA)
- …new equipment. Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, and client criteria. Performs self and peer ... review of the data for accuracy and compliance with reporting requirements. Education and Experience: + At...PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance as appropriate + Ability to utilize Microsoft… more
- UPMC (Erie, PA)
- …provides study development and implementation assistance, submissions to the FDA , IRB processing, patient recruitment, study coordination, study-specific training, ... strategies to manage the care of patients participating in research, ensuring compliance with protocol procedures, assessments, and reporting requirements as well as… more