- Edwards Lifesciences (Allentown, PA)
- …up. **How you'll make an impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior ... lives. This is an exciting opportunity for an exceptional Clinical Scientist professional to join a team that is...for a dynamic portfolio of products across TMTT. The Senior Manager will be an experienced medical device professional… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all ... development activities in support of domestic and international clinical development initiatives. The Senior Director, GCD...Neurology is highly desired. Minimum of five years of clinical research experience (post Academia). + Requires… more
- Sanofi Group (Swiftwater, PA)
- …computational systems biology, or applied mathematics + 7+ years' experience in pharmaceutical clinical research with at least 3 years modelling experience + ... **Job Title:** Senior Lead Clinical Modeler-Vaccines **Location:** Cambridge,...implement novel methodologies and invest in expanding expertise across clinical , regulatory , and commercial domains + Demonstrate… more
- ICON Clinical Research (Blue Bell, PA)
- Clinical Scientist ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment ... clinical trial protocols, ensuring adherence to scientific and regulatory standards. + Conducting data analysis and interpretation to...sciences, medicine, or a related field. + Experience in clinical research or a related scientific role,… more
- Organon & Co. (Plymouth Meeting, PA)
- …site personnel and investigators. Competencies + Phase 1 study operations + ICH/GCP + Clinical research + Clinical development + Vendor selection and ... as the point of contact for study-related vendors, including the study contract research organization (CRO) and/or clinical study sites or other vendors, as… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …data, including facilitating the resolution of data queries under the guidance of the Clinical Research Associate (CRA), Data Management and/or the Clinical ... and collection of study-specific documents required in the site's Regulatory Binder. + Assist in tracking study activies and...Minimum of two (2) or more years experience in clinical research , with medical device and/or pharmaceutical… more
- University of Pennsylvania (Philadelphia, PA)
- …Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job Description Summary With the oversight ... Affairs assists the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities… more
- Penn Medicine (West Chester, PA)
- …to finish working closely with the Abramson Cancer Center One Penn Medicine Cancer Clinical Research (ADD OCCR) Regulatory coordinators to manage, review, ... + The Associate Director Oncology Research Operations reports directly to the Senior Director of Magnet, Clinical Advancement and Community Impact at Penn… more
- Sumitomo Pharma (Harrisburg, PA)
- …of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical ... Health Authorities + Assist with development of the global regulatory functional plan through research , review and...to electronic regulatory submissions and working with regulatory templates + Understanding of EU Clinical … more
- Sumitomo Pharma (Harrisburg, PA)
- …understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical ... staff Phases I-IV Research & Development Activities + As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as… more
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