- Merck (West Point, PA)
- …platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and ... management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …inventory of pharmaceutical samples to field representatives. + Ensure compliance with regulatory tracking and reconciliation requirements. + Coordinate with ... working with field support or commercial operations teams. + Knowledge of compliance requirements related to pharmaceutical samples. **Preferred:** + … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** ... trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible… more
- UPMC (Altoona, PA)
- …external groups. They also support and/or lead patient care quality and regulatory compliance initiatives designed to improve medication-use processes or ... assessment, detection, mitigation, and prevention of medication-related adverse events and regulatory non- compliance . Pharmacists serve as resources and liaisons… more
- Lilly (Philadelphia, PA)
- …transfer, cGMP manufacturing, analytical development, release, quality control, and regulatory expectations for pharmaceutical products. + Direct experience ... Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority assets… more
- Merck (West Point, PA)
- …and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation. Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC Data Analyst,… more
- Sumitomo Pharma (Harrisburg, PA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Sumitomo Pharma (Harrisburg, PA)
- …during IND submissions, clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with regulatory ... 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
- Charles River Laboratories (Wayne, PA)
- …and reports and inspections of a variety of processes to assure compliance with applicable regulatory requirements, international standards, and corporate ... client visit and regulatory inspection find.ings. + Provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of… more
- Guthrie (Sayre, PA)
- …has broad oversight responsibilities across core domains: + Clinical Research Operations in compliance and in regulatory areas. + Supports research and scholarly ... in STEM discipline). + Minimum 3-5 years of direct experience in clinical or pharmaceutical -sponsored research or regulatory fields such as the FDA, NIH, or HHS.… more