- Sumitomo Pharma (Harrisburg, PA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Wolters Kluwer (Harrisburg, PA)
- …Manager** will be calling primarily on Librarians, Information Scientists, Heads of Global Regulatory Affairs , Directors of Medical Affairs , and the C-suite. ... They will both expand the customer base and grow existing customer business through strong product knowledge, effectively understanding customer needs and adeptly positioning Ovid's content and value proposition with our customers. The Senior Account &… more
- University of Pennsylvania (Philadelphia, PA)
- …regulations, GCP and IND/IDE in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and Quality ... the year. This allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with family-whatever your personal needs… more
- Pfizer (Collegeville, PA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong… more
- Highmark Health (Harrisburg, PA)
- …position serves as a key liaison between Claims Operations, Customer Service, Regulatory Affairs , IT, Legal and other departments, proactively identifying, ... assessing, and mitigating compliance risks. The Analyst will monitor regulatory changes, interpret their impact on operational processes, and implement effective… more
- KPH Healthcare Services, Inc. (Latrobe, PA)
- …to provide improved efficiencies, profitability, and customer service. + Responsible for all regulatory affairs as it pertains to pharmacy to ensure all ... locations are operating within state, federal and other regulatory guidelines, and corporate policies are adhered to + Responsible for the monitoring of bench… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies and optimize ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be… more
- UPMC (Johnstown, PA)
- …Assists at other UPMC Radiation Oncology locations if the need arises. + ** Regulatory Affairs Management** : Participates in regulatory compliance activities ... and maintains continuous departmental readiness for inspections and surveys. Follows all radiation safety standards. Wears radiation monitoring badge and ID badge at all times. Remains HIPAA compliant at all times. Completes clinical competencies annually as… more
- Envista Holdings Corporation (Quakertown, PA)
- …Quality Management System (QMS). The position will work together with Regulatory Affairs , Engineering, Operations, and Purchasing/Procurement to ensure product ... growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced… more