- Merck & Co. (North Wales, PA)
- Job DescriptionTh e Health Literacy Specialist role in the Medical Writing & Disclosure (MW&D) department will be primarily responsible for preparing Plain Language ... es and standards to ensure compliance with internal policy, regulatory requirements, and health literacy principles . - Under...supervision of the MW&D Health Literacy Projects Lead, the Specialist will be responsible for : - Authoring accurate… more
- Merck & Co. (North Wales, PA)
- …Review Team (PRT) approvals, and production.Maintains working knowledge of regulatory guidance & delivers compliant programs.Manages creation and monitoring of ... Agency scope of work (SOWs) and Agency evaluation process. Accountable for the operational proficiency of Agencies and other channel outsourced vendors.Oversees the appropriate administration of promotional budgets for projects and deliverables.- Customer… more
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC, commercial, and other areas) as ... to the information that they need.Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common projects.… more
- Merck & Co. (Philadelphia, PA)
- …and / or improve Third Party/Supplier relationshipsKnowledge of Finance, Regulatory /Quality, Privacy and Legal expectations for Global ProcurementRole is expected ... to follow the current hybrid working model.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist A (Department of Otorhinolaryngology) Job Profile Title Clinical ... Research Regulatory Specialist A Job Description Summary The Clinical Research Regulatory Specialist position will assist in maintaining regulatory … more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title Clinical ... Research Regulatory Specialist B Job Description Summary The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine maintenance of… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Quality Assurance Specialist ( Regulatory ) CVPF(Center for Cellular Immunotherapy) Job Profile Title ... Research Coordinator Senior Job Description Summary The Quality Assurance Specialist will work within the Clinical Cell and Vaccine Production Facility (CVPF) for… more
- Globus Medical, Inc. (Audubon, PA)
- …possible. **Position Summary** **:** Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with ... Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps… more
- University of Pennsylvania (Philadelphia, PA)
- …Assurance Specialist (Abramson Cancer Center) Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary The Abramson Cancer Center ... The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase… more
- University of Pennsylvania (Philadelphia, PA)
- …with the current approved study documents, ICH GCP, and with the applicable regulatory requirements. + The Quality Specialist is to confirm documentation ... and much more. Posted Job Title Clinical Research Quality Specialist C (Office of Clinical Research) Job Profile Title... is to ensure the site subject binders and regulatory files are complete and up to date. +… more
- University of Pennsylvania (Philadelphia, PA)
- …off site and flexible hours. Clinical Research Coordinator B will assist the regulatory specialist in preparing for all local and Central Institutional Review ... responsibilities above, the Clinical Research Coordinator B will assist the regulatory specialist in preparing for all local and Central Institutional Review… more
- University of Pennsylvania (Philadelphia, PA)
- …coordinator activities such as: Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions. Communicate with study ... submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects occur throughout the… more
- Merck (West Point, PA)
- **Job Description** **Position Description** **Senior Specialist , Quality** The Senior Quality Specialist , with guidance from the Integrated Product Team (IPT) ... reliable release of quality products to the marketplace. The Senior Quality Specialist ensures all necessary documentation (CRs, IQ/OQs, PQs, QNs etc.) is approved,… more
- Penn Medicine (Philadelphia, PA)
- …you living your life's work? **Summary:** The Transplant Performance Improvement Outcomes Specialist is focused on the core components of quality, patient safety, ... and regulatory standard compliance for a designated solid organ transplant...designated solid organ transplant program(s). The Transplant (PI) Outcomes Specialist utilizes medical records, data systems, best practices, analysis… more
- Penn Medicine (Philadelphia, PA)
- …Pathology and Laboratory Medicine has an exciting opportunity for an experienced Technical Specialist in its Electron Microscopy lab which is located in the Gibson ... functions with residents/fellows, Medical Laboratory Science and other students. + ** Regulatory Compliance** : Works with the Division's Quality Assurance manager in… more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Research Specialist C/D (Center for Cellular Immunotherapy) Job Profile Title Research Specialist ... C Job Description Summary The Human Genome Editing Research Specialist will play a key role in managing the Human Genome Editing Lab (HGEL) at the Center for… more
- Penn Medicine (Philadelphia, PA)
- …Team!! Penn Medicine is seeking a full-time, day shift Inpatient Clinical Pharmacy Specialist , Neonatal at the Hospital of the University of Pennsylvania (HUP). The ... of the University of Pennsylvania is recruiting for a Neonatal Clinical Pharmacy Specialist ! The Hospital of the University of Pennsylvania (HUP) is Penn Medicine's… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Research Specialist C Job Profile Title Research Specialist C Job Description Summary ... Pennsylvania is seeking a highly motivated and organized Research Specialist . The research interests of the Center lie at...will be expected to develop and implement protocols and regulatory documents for the preparation of imaging contrast agents… more
- University of Pennsylvania (Philadelphia, PA)
- …and wellness programs and resources, and much more. Posted Job Title Research Specialist A (Department of Neurosurgery) Job Profile Title Research Specialist A ... management of laboratory tools, documentations and processes to ensure regulatory compliance and timely completion of project/program deliverables. Job Description… more
