- Merck (Harrisburg, PA)
- …management, communication, and networking skills + A thorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant ... to the pharmaceutical industry and its customers + Ability to organize, prioritize, and work effectively in a constantly changing environment + Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote) + Familiarity with… more
- Charles River Laboratories (Spring House, PA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. If you are interested in applying to… more
- CTG (Myerstown, PA)
- …and in hybrid environments. + Knowledge of regulatory compliance and FDA guidance for dissemination of medical information. **Experience:** + Proven experience ... in clinical, medical affairs, or related roles within radiology or medical science liaison functions. + Experience with advisory boards, speaker training, and investigator-initiated research. + Demonstrated ability to manage scientific discussions, data… more
- Rise Baking Company (York, PA)
- …using established laboratory/pilot lab/plant methodology, ensuring all experiments meet FDA food manufacturing guidelines; keep accurate and detailed records and ... documentation on lab work and data analysis + Interpret experiment results and translate them into actionable recommendations and business solutions + Lead/support the planning, execution, and reporting of plant trials and product validations for new products… more
- Commonwealth of Pennsylvania (PA)
- …in specialized training and inspections for various programs, including Shellfish, FDA Contract Inspections, and HACCP protocols, while also preparing detailed ... reports and documentation related to inspections for supervisory review. Additionally, your findings will inform critical decisions that affect food policies, regulations, and consumer safety. This position demands a proactive approach to identifying potential… more
- GE HealthCare (State College, PA)
- …instruments (micrometers, calipers, CMMs). + Maintain documentation in compliance with FDA , ISO 13485, and GMP standards. + Collaborate with quality assurance ... and engineering teams to ensure product conformity. + Maintain a clean and organized work area, adhering to cleanroom protocols when required. + Troubleshoot machining issues and suggest process improvements. + Experience with CAD/CAM/Mastercam software. +… more
- Sanofi Group (Swiftwater, PA)
- …current good manufacturing practices (cGMP) for all relevant regulatory agencies (eg FDA ). Positions within production facilities may change based off of business ... needs and seasonality. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies… more
- Penn Medicine (West Chester, PA)
- …all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.)Staying current with communications from the ... Patient Access Management Team while remaining flexible and readily adopts new processes and engages in practice operation changes.Coordinates clinical and administrative aspects of the new patient scheduling encounter.Perform within the expected outcome of… more
- Pfizer (Collegeville, PA)
- …and interacting with Regulatory agencies worldwide (Influenza/COVID-19) or the US FDA (COVID-19). At Pfizer Global Regulatory Sciences contribution is "end to ... end". The responsibilities of this position will include development, licensure and post-authorization involvement. **ROLE RESPONSIBILITIES** + Responsible for the production, updating and communication of global regulatory strategies for assigned projects/… more
- University of Pennsylvania (Philadelphia, PA)
- …Project Manager in submitting documents to regulatory authorities (eg IRB, FDA , etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer). + ... Ensure that all research is conducted safely and according to protocol. Includes maintenance of study source documents and essential regulatory documents; reporting of adverse events; understanding of good clinical practice (GCP); and ensuring compliance with… more