- Cytel (Harrisburg, PA)
- …& Compliance :** + Ensure all processes and deliverables meet regulatory requirements and internal quality standards. + Support audit readiness and continuous ... others to do the same. Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at… more
- Sumitomo Pharma (Harrisburg, PA)
- …Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …of Pharmaceuticals Warehouse activity will be preferred + Knowledge of GMP and regulatory requirements for the pharmaceutical industry. + Strong proficiency with ... responsible for batch disposition and other quality functions in the pharmaceutical distribution center. Job Responsibilities Note: These statements are not intended… more
- Merck (North Wales, PA)
- …In-depth expertise in local regulatory frameworks, ethical standards, and pharmaceutical compliance requirements. + Proven capability to cultivate and ... Team Leadership, Executive Leadership, Healthcare Delivery Systems, Medical Affairs, Pharmaceutical Compliance , Scientific Communications, Scientific Exchange, Strategic… more
- UPMC (Pittsburgh, PA)
- …for someone who has an interest in oncology and thrives off providing amazing pharmaceutical care. This is a full-time position that will work daylight hours, Monday ... package. Apply today to learn more! The Lead Pharmacy Technician provides pharmaceutical care to patients within the UPMC Health System by demonstrating proficiency… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- University of Pennsylvania (Philadelphia, PA)
- …reviews, amendments, and adverse event reporting. + Prepare and process all regulatory documentation with pharmaceutical companies and CROs. + Obtain the ... CVs and medical licenses, record of IRB certification and compliance ). + Resolve regulatory related queries with IRB, study sponsors and CROs. Qualifications… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust ... appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product… more
- Fujifilm (Harrisburg, PA)
- …risks affecting the Medical Device businesses, including with respect to healthcare regulatory compliance , anti-kickback statutes, the False Claims Act, US ... HLUS' Medical Device businesses on substantive legal topics relevant to healthcare regulatory compliance , as assigned by Division General Counsel. + Contribute… more
- J&J Family of Companies (Horsham, PA)
- …partners to understand MSL and HCP educational needs and provide solutions within compliance and regulatory confines. + Develop and maintain effective working ... + Experience in Oncology or related therapeutic areas. + Experience in pharmaceutical health care compliance environment for external communication of scientific… more