- University of Pennsylvania (Philadelphia, PA)
- …preparation of research protocols and documents. + With the help of the project manager , manage/coordinate/organize the daily work of research assistants for ... QA activities, and handle monitor/audit visits with CROs, the FDA and other entities. + Correspond regularly with the...QA activities, and handle monitor/audit visits with CROs, the FDA and other entities. + Correspond regularly with the… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Information Systems Security Professional (CISSP), Certified Information Security Manager (CISM), Certified Information Systems Auditor (CISA), Certified in ... and standards, including NIST, ITIL, GDPR, and ISO. + Understanding of FDA cybersecurity guidance, ISO 13485, IEC 81001-5-1, and NIST Cybersecurity Framework.… more
- AbbVie (North Chicago, IL)
- …for US and foreign patent prosecution, listing patents in the FDA 's Orange Book, analyzing freedom-to-operate issues, addressing contractual issues, evaluating ... on a broad range of matters involving the Food and Drug Administration ( FDA ), Federal Trade Commission (FTC), Office of Inspector General (OIG), and other applicable… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... inception (Phase 1-3) to successful product approval by the FDA and other regulatory agencies. + Design and review...to maintain awareness of research activities and represent a project and/or the company + Participate in cross-functional teams,… more
- Philips (Plymouth, MN)
- …specific regulatory tasks in support of a regulatory filing or department project with direct support from management or more senior regulatory affairs specialists. ... Under the supervision of the Regulatory Affairs (RA) Manager or a more senior Regulatory Affairs Specialist, a...CMDR, MDSAP and all other applicable regulations. + Applying FDA , ISO, EU, and other applicable regional regulations **You… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …of what happens in our global development organization + Completing a hands-on project that has an impact on the business + Engaging with Regeneron leadership ... + Collaborating with a specific hiring manager and other interns + Establishing connections with Regeneron's...sessions + Getting paid for your hard work! **Internship Project Specifics:** The summer intern will be placed on… more
- Fresenius Medical Center (Ogden, UT)
- …management to determine feasibility of solution opportunities. Documents and communicates project plans and process workflows as required. PRINCIPAL DUTIES AND ... development of others' abilities to service the various controls systems. + Participates in project teams with a focus to ensure projects are completed both on time… more
- BD (Becton, Dickinson and Company) (Hunt Valley, MD)
- … project goals + Provides guidance to Package Engineering Manager to accomplish departmental and organizational strategies including cost reduction, reduced ... Diagnostic Solutions BU and reports directly to the Packaging Engineering Manager . This position supports the organization's central initiatives by driving growth… more
- ThermoFisher Scientific (Wilmington, NC)
- …templates and other protocol specific documents as required. + Collaborates with the project manager to prepare, organize, and present at client meetings, ... monitoring clinical activity timelines and metrics, providing status updates to the project manager , regularly reviewing projects using tracking and management… more
- HCA Healthcare (Nashville, TN)
- …+ Individual will receive negotiation guidance and oversight from legal and manager but is mostly expected to execute based on their individual experience/knowledge. ... Minimal oversight and guidance will be provided by the negotiator's manager . + Individual will participate in continuous improvement initiatives in the negotiation… more