- Parexel (Harrisburg, PA)
- …Regulatory Authority meetings) **Literature review (as applicable)** + Review of literature for product safety assessment and potential safety issues + ... therapeutic area training), as requested, at internal and external meetings (such as investigator meetings) + Provide medical safety expertise to client per… more
- Parexel (Harrisburg, PA)
- …for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in ... of clinical trials (eg enrollment, database release), to safeguard the quality of investigator sites (eg patient safety , site quality and compliance with GCP),… more
- Parexel (Harrisburg, PA)
- …for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in ... of clinical trials (eg enrollment, database release), to safeguard the quality of investigator sites (eg patient safety , site quality and compliance with GCP),… more
- Pfizer (Collegeville, PA)
- …Oversees and performs proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety ... of the benefit-risk profile across Pfizer's portfolio and to advocate for patient safety from first-in-human and throughout a product 's lifecycle. The SSRM … more
- J&J Family of Companies (Horsham, PA)
- …the US Medical Affairs Immunology team, where you will influence product development, scientific communication, and evidence generation efforts, ensuring alignment ... development, regulatory communications, academic and community-based IBD HCP and investigator interactions, support of execution, and supervision of clinical studies… more
- University of Pennsylvania (Philadelphia, PA)
- …in clinical research ranging from observational trials to investigational product trials, including both investigator -initiated and industry-initiated trials. ... in clinical research ranging from observational trials to investigational drug/ product trials, including investigator -initiated, government funded, and… more
- University of Pennsylvania (Philadelphia, PA)
- …support the fast-paced day-to-day operations of multiple clinical trials, investigator -initiated studies, and translational biobank projects focused on dermatologic ... QC and address queries. * Show vigilance in participant safety , protocol compliance and data quality. * Adhere to...to study timelines and procedures. Meet with the Principal Investigator to review subject status, assess required next steps,… more
- CSL Behring (King Of Prussia, PA)
- …of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). The GCPL is accountable for the strategic leadership of the ... the Clinical Development Plan (CDP), the Project Strategy Document (PSD), Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms (ICF),… more
- J&J Family of Companies (Horsham, PA)
- … Product Portfolio Management, Report Writing, Research and Development, Safety -Oriented, SAP Product Lifecycle Management, Statistics, Technical Credibility, ... for humanity. Learn more at https://www.jnj.com **Job Function:** R&D Product Development **Job Sub** **Function:** R&D Digital **Job Category:**… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …+ Serve as part of Otsuka's internal speaker bureau in support of product educational needs across the ecosystem. + Collect and submit medical insights that ... with Otsuka's clinical trials program, including registrational, post-marketing and Investigator -Sponsored Trials (ISTs), health economic outcomes research, other specific… more
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