- Edwards Lifesciences (Harrisburg, PA)
- …Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs , Biostatistics, R&D, QA and Marketing on clinical data ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- PNC (Pittsburgh, PA)
- …management, line of business, finance, risk management, internal audit, legal, and regulatory affairs partners across PNC. Your work will contribute directly ... + Works with internal teams including business lines, finance, risk management and regulatory affairs . + Executes business strategy and coordinates responses and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …issues, protocol deviations, and potential noncompliance. + Collaborate with Clinical Operations, Regulatory Affairs , and Medical Affairs to embed quality ... quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role… more
- Merck (West Point, PA)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs , clinical operations, and CMC teams. + **Reporting & ... implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert...robust study design and high-quality PET data collection. + ** Regulatory support** : Familiarity with regulatory and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Disclaimer** This job description is intended to describe ... lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D,… more
- West Pharmaceutical Services (Williamsport, PA)
- …and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs , personnel, department resources, and continuous improvement ... processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... study protocols are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans. The Clinical… more
- FirstEnergy (PA)
- …a subsidiary of FirstEnergy Corp. This position is in the Pennsylvania Rates & Regulatory Affairs group. The preferred reporting location is Reading, PA, however ... + Help shape the overall strategic direction for FirstEnergy through various regulatory proceedings (including supporting the writing of testimony and the discovery… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more