- ThermoFisher Scientific (Allentown, PA)
- …Thermo Fisher Scientific to support the Packaging Engineering of Commercial Drug Products. This role includes design, development, qualification, documentation, and ... and fully automatic packaging of ambient and cold chain commercial drug products including auto injectors. Additionally, you will lead serialization activities… more
- Norstella (Harrisburg, PA)
- …life-saving therapies. Norstella supports pharmaceutical and biotech companies across the full drug development lifecycle - from pipeline to patient. Our mission is ... strategic, clinical, and commercial decision-making. We help our clients: + Accelerate the drug development cycle + Assess competition and bring the right drugs to… more
- Charles River Laboratories (Wayne, PA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- Walgreens (Pittsburgh, PA)
- …analyzing results; and implementing changes. Helps ensure area Pharmacies adhere to regulatory compliance, standard operating procedures and FDA regulations. + ... by increasing focus on healthcare services (eg patient consultation, medication management, drug therapy reviews, and retail, clinical, or wellness services such as… more
- Parexel (Harrisburg, PA)
- …when applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, ... to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator… more
- GE HealthCare (State College, PA)
- …communication, and stakeholder engagement skills. **Preferred Attributes** + Experience with FDA , ISO 13485, and healthcare regulatory standards. + Familiarity ... optimization across supply chain functions. Enable scalable production and regulatory compliance through advanced manufacturing technologies. **Key Responsibilities** +… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …the client partnership to ensure alignment and consensus + Participate in Regulatory Inspections and Customer Audits, etc + Participate in site and customer ... regulations, required; prefer experience in multiple regions (eg EU, ANVISA, FDA , Etc.) + Experience working with customers - Contract manufacturing experience,… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to UPHS, JCAHO, GCP and other regulatory standards. Job Description Job Responsibilities Clinical Research Nurse C Responsibilities ... trials. Participate in the conduct of audits by study sponsors, CROs, the FDA , the Eastern Oncology Group, the University of Pennsylvania's CTSRMC, and other groups.… more
- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …and maintains accurate records in compliance with accrediting agencies such as CAP/TJC/ FDA /AABB/CLIA. Uses independent judgment to consult and provide guidance to ... in a testing designated position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to be tested will be denied… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death &… more