- Globus Medical, Inc. (Audubon, PA)
- …in a timely manner + Communicating any and all product concerns to Manager , Quality, Accounting, and Product Development Management as necessary + Following all ... Medical's Quality Policy and Employee Handbook to ensure total conformity with the FDA and other government agencies + Assisting Shipping Dept. as needed, possibly… more
- Parexel (Harrisburg, PA)
- …applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, corporate ... content review. **Document Project Management** + Act in the capacity of project manager /lead for medical writing projects, which may entail serving as the primary… more
- UPMC (Bridgeville, PA)
- …productivity. + Maintain assigned vehicle in a clean and orderly condition; inform Manager of Pharmacy of mechanical problems. + Pick up sharps containers and ... compliance with State, local, and Federal laws and/or regulations (including FDA , DOT,OSHA,etc.) + Maintain confidentiality of patient information. + Document… more
- Penn Medicine (Philadelphia, PA)
- …materials as needed. + Promptly performs call-backs as directed by provider and manager . + Provides patients with follow up care instructions as instructed by ... with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc.). + Flexible and readily adopts new… more
- University of Pennsylvania (Philadelphia, PA)
- …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 a timely manner. ... Essential: 1),Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all other applicable review + Other duties and responsibilities as… more
- University of Pennsylvania (Philadelphia, PA)
- …compliance and data quality. * Adhere to all University of Pennsylvania, FDA and GCP guidelines. * Effectively and independently managing multiple trials while ... for participant recruitment. * Work closely with the Clinical Research Program Manager on study start-up activities. Job Description Job Responsibilities + Lead… more
- Xylem (Philadelphia, PA)
- …+ Responsible for documentation requirements in accordance with other government agencies ( FDA , EPA, DOT). + Work closely with cross-functional teams and other ... EEI filings. + Other responsibilities as assigned by the Trade Compliance Manager . **Skills and Qualifying Experience:** + 5+ years Trade Compliance related… more
- University of Pennsylvania (Philadelphia, PA)
- …and research related presentations. Works closely with the Principal Investigator, manager , and study team to identify problems and develop solutions. Implement ... and data entry + Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines + Assure compliance with the protocol and regulatory requirements… more
- Parexel (Harrisburg, PA)
- …Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (eg Clinician, ... + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent in English and in… more
- Penn Medicine (Philadelphia, PA)
- …hours required. **Summary:** + The Medical Assistant (MA) assists the practice manager and physicians in maintaining a patient/customer focus, supports the delivery ... with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and readily adopts new processes… more