- NTT DATA North America (Pittsburgh, PA)
- …certification (nice-to-have, but not mandatory). + Knowledge of healthcare regulations and compliance standards (eg, HIPAA, FDA ). Education: + Bachelor's degree ... projects. + Perform detailed data analysis to support business decisions, ensuring compliance with industry regulations. + Track and report on remediation progress,… more
- NTT DATA North America (Pittsburgh, PA)
- …certification (nice-to-have, but not mandatory). Knowledge of healthcare regulations and compliance standards (eg, HIPAA, FDA ). Education: Bachelor's degree in ... projects. Perform detailed data analysis to support business decisions, ensuring compliance with industry regulations. Track and report on remediation progress,… more
- Organon & Co. (Plymouth Meeting, PA)
- …time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures (centralized, mutual recognition, decentralized) + Independently manage ... Represent our company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies, including telephone calls and… more
- PCI Pharma Services (Philadelphia, PA)
- …equipment set ups, repairs and installation to meet customer requirements. + Assure compliance to GMP's, SOP's, FDA , DEA and OSHA rules and regulations. ... + Interact with all customers and management to achieve objectives. + Able to balance multiple issues simultaneously in a fast pace environment + Coordinate resources with requirements that are driven by the production schedule. + Instruct mechanics on their… more
- University of Pennsylvania (Philadelphia, PA)
- …with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is ... the conduct of audits by study sponsors, CROs, the FDA , and other entities as required. + Process and...and/or CROs. + Show vigilance in patient safety, protocol compliance , and data quality. + Adhere to all University… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... softwareEssential Functions + Performs internal quality audits and effectiveness reviews ( FDA 's QSR, ISO 13485, MDD, CMDR) Conducts supplier evaluations and audits… more
- University of Pennsylvania (Philadelphia, PA)
- …visits. Participate in study team meetings and ongoing protocol training/ compliance meetings. Demonstrate vigilance in patient safety, protocol compliance ... , and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Job Description Clinical Research Coordinator BWith minimal supervision, the… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The ... specifications for new product development . Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project . Manages all aspects… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The ... specifications for new product development + Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project + Manages all aspects… more
- Sumitomo Pharma (Harrisburg, PA)
- …relevant external advertising & promotional regulations or codes of practice (eg, FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding ... of promotional materials, eg Marketing and their Agencies, Legal, Compliance , and Medical Affairs. + Provide appropriate oversight of...with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on … more