- Merck & Co. (North Wales, PA)
- …a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projectsAssist ... Job DescriptionOur Clinical Research team push the boundaries...clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Key Functions: Specific Responsibilities Evaluating pre-… more
- Merck & Co. (North Wales, PA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Pain, Neuroscience, Neuroscience Research , Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance, Scientific… more
- Merck & Co. (North Wales, PA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology.… more
- Merck & Co. (Upper Gwynedd, PA)
- …(including discovery research , biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout sites in the USA, UK… more
- Merck & Co. (North Wales, PA)
- …Affairs , Manufacturing, Global Marketing, Global digital data and analytics, PDT/ Research & Development, Policy, Regulatory , Legal/Compliance teams, and other ... skills and executive presence Understanding of the US commercial and regulatory requirements Marketing Communications and Market Research experience Required… more
- CSL Behring (King Of Prussia, PA)
- …active inputs from key stakeholders in medical affairs , sales, commercial development, clinical research and development, regulatory affairs , etc. ... Operations input is provided in the development of Target Product Profiles, clinical research protocols and Target Labeling copy through appropriate channels… more
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- Organon & Co. (Plymouth Meeting, PA)
- … Epidemiology and Economics will report to the headquarters Director of Medical Affairs Outcomes Research . Focusing on Dermatology, in this role, you will ... be responsible for establishing/continuing economic Modelling research programs that include developing, design and delivering health economic modelling projects.… more
- Organon & Co. (Plymouth Meeting, PA)
- …work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing ... 1 to 2a study protocols, in collaboration with internal (biostatistics, clinical operations) and external (contract research organization [CRO], bioanalytical… more
- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... and approval in one key region (EU, US, Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health… more
- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... and approval in one key region (EU, US, Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health… more
- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Affairs Specialist Job Profile Title ... Clinical Research Regulatory Specialist B Job Description Summary ...Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff… more
- University of Pennsylvania (Philadelphia, PA)
- …as the primary point of authority for the Physician-Investigators and clinical research staff on regulatory affairs matters. The Associate Director for ... Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job Description...the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical … more
- Penn Medicine (Philadelphia, PA)
- …PA + Hours: 8hr Days **Summary** : The Senior Corporate Director of Regulatory Affairs for Penn Medicine provides leadership and strategic direction across ... Management and Leadership: Manage and provide leadership to all entity directors of regulatory affairs , ensuring alignment with Penn Medicine goals and … more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B...cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time … more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …and database software. Screens, recruits, and assesses potential participants for research or clinical demonstration eligibility; reviews medical charts and ... designs, protocols, and data collection method; (2) ensuring compliance with research protocols, ethical standards, and regulatory guidelines. OR, Education:… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …diverse backgrounds and beliefs - Adaptability: Flexibility in adapting to changing clinical situations, work schedules, regulatory environments, and advances in ... includes in-person and telehealth Veteran encounters. Although the Hospice Clinical Director is the primary provider in the Hospice...program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). You may be required… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …Medical and Surgical specialties using ionizing radiation in a clinical /academic/ research setting under a single Nuclear Regulatory Commission (NRC) broad ... and the CMCVAMC's Community Living Center (CLC). The DMP supports the clinical operations, research programs, and teaching activities that deal with… more
- University of Pennsylvania (Philadelphia, PA)
- …all applicable institutional regulatory review committees. In collaboration with clinical research teams and investigators he/she will prepare, and process ... call home for work and play. Posted Job Title Clinical Research Specialist Job Profile Title Temporary...Affairs Specialist post-site initiation. He/she will participate in regulatory staff meetings, research team meetings, and… more
- University of Pennsylvania (Philadelphia, PA)
- …reporting and all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs). Assist with creation of master trial ... programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B Job Profile Title...data and regulatory files per GCP.Work with Regulatory Affairs Specialist to prepare for audits,… more
