- Olympus Corporation of the Americas (Center Valley, PA)
- …and strengthen market engagement. + Continuously monitor and interpret evolving global clinical and regulatory landscapes, as well as emerging industry guidance ... between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs, and investigational sites. + Ensure clinical studies are… more
- Penn Medicine (Radnor, PA)
- …departments/entities, academic involvement (research initiatives, resident program), special clinical programs, regulatory requirements, support of external ... the Nursing Professional Development team. + Ensures staff are compliant with clinical competencies and mandatory trainings. + Regulatory Compliance: + Assists… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- … clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is ... + Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy. + Working with experts and consultants in the field to… more
- Penn Medicine (Philadelphia, PA)
- …the Director, and members of the PTI leadership team to support clinical , quality, regulatory compliance, information systems, fiscal, and research goals ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- Penn Medicine (Philadelphia, PA)
- …on strategies and/or actions necessary to improve compliance to include regulatory , clinical performance, and/or safety outcomes. Develops, maintains, and ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- Merck (West Point, PA)
- …channels & decision-making processes between GCS and GCTO, including engagement with Clinical and Regulatory Organizations - communication channels + Monitor all ... of urgency and proactive approach to problem resolution + Understanding of regulatory frameworks in Clinical trials or clinical _supplies_ , GCP, GDP & GMP,… more
- Penn Medicine (Philadelphia, PA)
- …departments/entities, academic involvement (research initiatives, resident program), special clinical programs, regulatory requirements, support of external ... the Nursing Professional Development team. + Ensures staff are compliant with clinical competencies and mandatory trainings. + Regulatory Compliance: + Assists… more
- Penn Medicine (Radnor, PA)
- …departments/entities, academic involvement (research initiatives, resident program), special clinical programs, regulatory requirements, support of external ... the Nursing Professional Development team. + Assures staff are compliant with clinical competencies and mandatory trainings. + Regulatory Compliance: + Assists… more
- IQVIA (Philadelphia, PA)
- …in lieu of degree. Req * Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. * ie, Good Clinical Practice (GCP) ... in accordance with contracted scope of work and Good Clinical Practice. * Work with sites to adapt, drive,...* Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report… more
- Penn Medicine (Philadelphia, PA)
- …forums to discuss and address regulatory issues. Ensure compliance with regulatory policies and standards, supporting clinical integration by standardizing ... Policy Alignment: Ensure alignment of all system policies for patient care and clinical practice with regulatory standards and organizational goals. Develop and… more