- J&J Family of Companies (Spring House, PA)
- …(Dx) sub-teams of CDTs, working closely with partners across Global Development, Clinical , Finance, IT, Global Regulatory Affairs , Commercial, Business ... in planning via financial systems (PLW/User Community Tool (UCT), Beacon) to support clinical development plans. + In Partnership with TR team members (ex. TR Leads… more
- Merck (North Wales, PA)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... brochures + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD)… more
- Merck (West Point, PA)
- …acumen and expertise in data and data standards across Clinical Development, Medical Affairs , and Regulatory Affairs domains. . Apply domain knowledge to ... Information Architecture (BIA) group within our Research & Development Division's Clinical Development and Digital Solutions (CDDS) value team, the Business Strategy… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance ... data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE...a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,… more
- Charles River Laboratories (Wayne, PA)
- …one or more Charles River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in implementing the ... applicable regulatory requirements. ⦁ Assume a key role in designated Regulatory Affairs and Compliance projects and programs. ⦁ Participate in Corporate… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- University of Pennsylvania (Philadelphia, PA)
- …Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision ... regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory...the FDA, as well as, organize and maintain all regulatory affairs documentation/files as required. The … more
- Sumitomo Pharma (Harrisburg, PA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... the Regulatory reviewer for assigned products. This position is responsible...strategies to optimize the commercial success of products for clinical trials, labeling, etc. + Develop and maintain productive… more
- Merck (North Wales, PA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- University of Pennsylvania (Philadelphia, PA)
- … regulatory binder for each study. Prepare and process all regulatory documentation with research sponsors and clinical research organizations (CROs). ... binder for each study. Prepare and process all regulatory documentation with research sponsors and clinical ...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more