- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... up to 10% of the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all… more
- University of Pennsylvania (Philadelphia, PA)
- …to participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory ... wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist-CC Job Profile Title Clinical Research Regulatory Specialist… more
- University of Pennsylvania (Philadelphia, PA)
- …approvals and associated site initiation documentation. Reporting to the Regulatory Affairs New Study & Continuing Review Manager , the Senior Regulatory ... wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Start-Up Specialist Senior-CC Job Profile Title Clinical Research … more
- PCI Pharma Services (Philadelphia, PA)
- …are properly followed and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective ... global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving… more
- Actalent (Philadelphia, PA)
- Job Title: Regulatory Affairs SpecialistJob Description We are seeking a full-time Clinical Research & Regulatory Affairs Specialist to work remotely for ... handle regulatory documentation for the NCI, organize and maintain all regulatory affairs documentation/files, resolve regulatory and data queries, and… more
- IQVIA (Wayne, PA)
- ** Manager , Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services ... practice Principals and other IQVIA teams to strengthen the Manager 's Medical Affairs and consulting expertise. +...life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would… more
- CSL Behring (King Of Prussia, PA)
- Associate Director, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Associate Director, Corporate and External Affairs , R&D Portfolio will ... Relationships:** + **Reports to:** Head of Corporate and External Affairs , R&D + **Direct reports to position:** 1 **Main...and partners. + Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities,… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …changes). Maintains functional knowledge of relevant safety codes and standards of regulatory bodies including but not limited to The Joint Commission (TJC), ... Protection Association (NFPA), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Association for the Advancement of Medical Instrumentation… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. +… more
- Wolters Kluwer (Philadelphia, PA)
- …The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic ... The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the...**Cross-Functional Collaboration:** Act as a liaison between engineering, product, regulatory affairs , clinical, and QA teams to… more
- University of Pennsylvania (Philadelphia, PA)
- …review proposals for compliance with sponsor and University policies and ensure Regulatory Affairs requirements are satisfied and that Conflict of Interest ... and resources, and much more. Posted Job Title Grants Manager A/B Job Profile Title Grants Manager ...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- University of Pennsylvania (Philadelphia, PA)
- …to ensure data is accurate, logical, and consistent with institutional and regulatory reporting requirements. The PDE Manager , with minimal direction, is ... and resources, and much more. Posted Job Title Process Development & Efficacy (PDE) Manager Job Profile Title Technical Operations Manager - Clinical Cell and… more
- University of Pennsylvania (Philadelphia, PA)
- …and resources, and much more. Posted Job Title Cardiac Surgery Program Manager (Department of Surgery) Job Profile Title Clinical Research Program Manager ... C Job Description Summary The Cardiac Surgery Program Manager will manage clinical research coordinators and associated research staff within Department of Surgery… more
- University of Pennsylvania (Philadelphia, PA)
- …and resources, and much more. Posted Job Title Clinical Research Nurse Project Manager (Department of Radiation Oncology) Job Profile Title Clinical Research Nurse D ... Job Description Summary The Clinical Research Nurse Project Manager will support all aspects of clinical research activities in the CRU that requires RN involvement,… more
- Organon & Co. (Plymouth Meeting, PA)
- …of industry experience in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... We are looking for an experienced Associate Director, Program Manager to join our team. This successful candidate will...drugs or devices which improve human health. The program manager may also be assigned to projects that contribute… more
- J&J Family of Companies (Spring House, PA)
- …more at https://www.jnj.com **Job Function:** Communications & Corporate/External Affairs **Job Sub** **Function:** Product Communications **Job Category:** ... currently searching for the best talent to join our team as a Senior Manager , Global Immunology Agile Communications! This is a hybrid in-person role with a location… more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Clinical Research Project Manager A Job Profile Title Clinical Research Project Manager A Job ... the Division with collaborating sites and external institutions. The project manager will interface with multiple investigators (internal & external), and will… more
- Penn Medicine (Philadelphia, PA)
- …including ACAs and/or RCAs. Partner with risk managers, patient safety officers, regulatory affairs , and senior leadership to advance key patient safety ... you living your life's work? **Summary:** The Patient Safety Manager reports to the Director of Patient Safety and...priorities and ensure with compliance with regulatory agencies. Analyze data (ie, Safety Net reports, patient… more
- University of Pennsylvania (Philadelphia, PA)
- …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 The Clinical Research Project Manager A/B will responsible for oversight, day-to-day management, execution and regulatory compliance of… more