- University of Pennsylvania (Philadelphia, PA)
- …approvals and associated site initiation documentation. Reporting to the Regulatory Affairs New Study & Continuing Review Manager , the Regulatory ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer...cutting-edge oncology treatments. Contingent upon funding. The CRU OCCR Regulatory Affairs Office seeks a full-time … more
- Veterans Affairs, Veterans Health Administration (Lebanon, PA)
- …& Sciences Care Line (BH&S), under the general supervision of the Business Manager for BH&S. The incumbent advises management on the establishment and progress of ... data for V-Tel clinics. Supports, coordinates, and assists managers and Business Manager in optimizing access to care and clinic utilization. Monitors, documents and… more
- Takeda Pharmaceuticals (Exton, PA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- CSL Behring (King Of Prussia, PA)
- …Team (PST), Clinical Development Team (CDT), and within Global Regulatory Affairs (GRA). **Experience** + Bachelor's degree (four-year university degree) ... an important leadership role as part of the Global Regulatory Affairs (GRA) GPS Leadership Team. You...including but, not limited to TA Leads and Global Regulatory Leads (GRLs). + Collaborate with manager … more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 67683 Date: Jan 11, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **Thank you for your interest in our Sr ... Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global...and SMEs (Subject Matter Experts) in R&D, quality assurance, clinical affairs , labeling, to align on deliverables… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Project Manager B (Abramson Cancer Center) Job Profile Title ... Clinical Research Project Manager B Job Description Summary The Abramson Cancer Center...the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies. Job Description Job Responsibilities + Manage single… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Project Manager A/B Job Profile Title Clinical Research ... Project Manager A Job Description Summary Clinical Research Project Manager A Responsible for... A Job Responsibilities + Manage single and multi-site clinical trials (including study start up, regulatory … more
- Globus Medical, Inc. (Audubon, PA)
- …to FDA + Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting ... patients can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k)… more
- University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Sr. Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job Profile Title ... phase clinical trials. Job Description The Sr. Clinical Trials Project Manager position works within...processes, procedures, and templates/tools to align with the changing regulatory landscape and new scientific innovation. + Ensuring the… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …which includes the following Olympus business functions: i) Research & Development, ii) Regulatory Affairs , iii) Quality Management and iv) Medical & Scientific ... and machine learning for predictive modeling and data analytics in R&D. *Collaborate with Regulatory Affairs team(s) to align the IT architecture to facilitate … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …other than @Olympus.com, it is likely not legitimate._ **Job Description** The Clinical Quality Assurance Manager reports directly to the Executive Director ... GCP, Industry guidelines, and Olympus policies and processes for the conduct of clinical studies. **Job Duties** + Maintain, and monitor Olympus GCP processes and… more
- University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A (Department of Endocrinology, Diabetes and Metabolism) Job ... Profile Title Clinical Research Coordinator A Job Description Summary This entry-level...requires significant dedication and resilience to acquire and apply regulatory knowledge with the duty to protect research patient… more
- University of Pennsylvania (Philadelphia, PA)
- …Will problem-solve the challenges to implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB are completed in ... auditing, and study close-out visits for complex Phase I-IV clinical trials. They will interface with regulatory ...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- University of Pennsylvania (Philadelphia, PA)
- …relating to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is an integral and ... closely with our clinical research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The ACC received an… more
- University of Pennsylvania (Philadelphia, PA)
- …preferred. Experience with medical imaging studies and a general familiarity with regulatory compliance and reporting are highly desirable. Clinical Research ... health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B/C (Department of Radiology) Job Profile Title Clinical… more
- University of Pennsylvania (Philadelphia, PA)
- …experience (or equivalent combination of education and experience). Phlebotomy and regulatory experience preferred. Clinical Research Coordinator C: Bachelor's ... website (https://coronavirus.upenn.edu/) for the latest information. Posted Job Title Clinical Research Coordinator B/C (Infectious Diseases) Job Profile Title … more
- University of Pennsylvania (Philadelphia, PA)
- …and ongoing protocol training/compliance meetings. Adheres to all University and other regulatory guidelines. The clinical trials will be conducted at Penn ... the Project Manager within the Interventional Radiology division of the Clinical Imaging Core. The CRC-A will have the following responsibilities: 1) Coordinate… more
- University of Pennsylvania (Philadelphia, PA)
- …resources, and much more. Posted Job Title Quality Assurance Specialist ( Regulatory ) CVPF(Center for Cellular Immunotherapy) Job Profile Title Research Coordinator ... Summary The Quality Assurance Specialist will work within the Clinical Cell and Vaccine Production Facility (CVPF) for the...issuance and external audits, DFPs, CAPAs review. + Assisting Manager as needed to help with raw materials release,… more
- University of Pennsylvania (Philadelphia, PA)
- …Responsibilities Clinical Research Coordinator A: Under direct supervision of senior clinical research coordinator or project manager , the primary role of ... calls to participants; includes tracking participants through the timepoints, and assists regulatory submissions as needed. Clinical Research Coordinator B: In… more
- University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B/C (Department of Medicine) Job Profile Title Clinical ... As part of the Department of Medicine, the DOM Clinical Trials Unit supports a diverse group of investigators,...review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects… more