- ICON Clinical Research (Blue Bell, PA)
- …Medical Director** specializing in **Pulmonology** to join our global Biotech Medical Affairs team. Working in a fast-paced, client-focused global ... **Stakeholder Communication & Leadership** + Engage with global stakeholders including regulatory authorities, key opinion leaders (KOLs), client medical teams,… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) ... regulatory / procedural deadlines. + Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and 21CFR803.… more
- University of Pennsylvania (Philadelphia, PA)
- …for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. ... comprised of 12 Research Teams that support disease/discipline specific medical oncology cancer programs within the ACC. The ACC...to research coordinator who provides study related support (eg, regulatory submissions and data entry). + May… more
- Merck (West Point, PA)
- …acumen and expertise in data and data standards across Clinical Development, Medical Affairs , and Regulatory Affairs domains. . Apply domain ... Computer Technology, Enterprise Architecture Management, Information Architectures, Life Science, Medical Affairs , Requirements Management, Strategic Management, Strategic… more
- Penn Medicine (Philadelphia, PA)
- …Risk Management/ Legal, Quality and Patient Safety, the Penn Medicine Academy, the Office of Medical Affairs (OMA), the Office of Patient Affairs (OPA), Penn ... RCAs. + Partner with risk managers, patient safety officers, regulatory affairs , and senior leadership to advance...key patient safety priorities and ensure with compliance with regulatory agencies. + Analyze data (ie, Safety… more
- University of Pennsylvania (Philadelphia, PA)
- …for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, and follow-up and regulatory documentation. ... Research Organizations (CROs) (ie, source documentation, case report forms, study and regulatory binders, and patient binders). + Resolve data queries with… more
- Sumitomo Pharma (Harrisburg, PA)
- …including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is ... and ensure patient safety. + Assist in signal detection activities including data assembly, signal validation, and signal evaluation. + Perform literature monitoring… more
- Pfizer (Collegeville, PA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... Support execution for all FIH programs through proof-of concept + Set the clinical data review strategy, ensure quality data and conduct review of emerging… more
- Merck (Upper Gwynedd, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5 more} **Preferred… more