- J&J Family of Companies (Spring House, PA)
- …precision, robustness, drug tolerance) and review associated reports according to regulatory expectations and departmental SOPs. + Lead troubleshooting and assay ... Drive effective communication and cross‑functional collaboration with R/D Clinical, Regulatory , Pharmacokinetics, CMC, Quality Assurance, and Data Management teams.… more
- CSL Behring (King Of Prussia, PA)
- …plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development ... with program objectives. + Partner with Therapeutic Area (TA) leadership, Regulatory , Safety, and other functions to integrate statistical strategy into clinical… more
- Edwards Lifesciences (Pittsburgh, PA)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. + Leading in the development of technical training on GCPs,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- UMB Bank (Harrisburg, PA)
- …This team provides timely, accurate, and seasoned judgment related to regulatory compliance risk, suggests strategies for mitigating risk, promotes a strong ... culture of compliance, and fulfills regulatory expectations of administering effective compliance monitoring and other mandated programs. As a Compliance Testing… more
- ICON Clinical Research (Blue Bell, PA)
- …Site Specialist II **Role Summary:** Support preparation, process and tracking of regulatory and site level critical documents and of site activation tasks required ... on program of studies to proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local… more
- Cytel (Harrisburg, PA)
- …complex consulting engagements, and guide clients in shaping optimal regulatory and clinical development pathways. **Strategic Consulting & Thought Leadership** ... in Quantitative Clinical Pharmacology, Pop-PK/PK-PD modeling, MIDD, and quantitative regulatory strategies. + Lead the development and dissemination of innovative… more
- Duquesne Light Company (Pittsburgh, PA)
- …a wide variety of substantive and complex analytical, business, rate-making and regulatory filings review that affects the operations of the Company. In addition, ... **Job Duties and Responsibilities:** + Prepares and assists with preparation of regulatory filings for the provision of retail electric services. Prepares and… more
- CSL Behring (King Of Prussia, PA)
- …and quality in safety data management across the R&D organization, supporting regulatory readiness and scientific integrity. **The Role** + Maintain PV data ... standards, taxonomies, and controlled vocabularies with global regulatory requirements (eg, ICH, EMA, FDA) + Lead governance...studies, and functions + Collaborate with teams (eg, Safety, Regulatory , Clinical, IT) to embed PV data standards into… more
- Penn Medicine (Philadelphia, PA)
- …and innovative for patient needs. DOO ensures compliance with regulatory bodies. **Responsibilities:** Department Strategic Planning & Change Management: + ... of quality patient care and customer satisfaction. + Ensure that all regulatory requirements are met. + Ensures effective utilization of tools, materials, staff,… more