- University of Pennsylvania (Philadelphia, PA)
- …The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement ... mission. Prepare draft PS-IDE applications for faculty review and submission to FDA . Draft components of clinical protocols and informed consents documents in… more
- Sumitomo Pharma (Harrisburg, PA)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- IQVIA (Pittsburgh, PA)
- …(samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. + Maintains accountability for all pharmaceutical ... samples in accordance with FDA and PDMA guidelines. + Utilize the sales automation...global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare… more
- Teleflex (Wayne, PA)
- …of people's lives. Through our vision to become the most trusted partner in healthcare , we offer a diverse portfolio with solutions in the therapy areas of ... and world-class products can shape the future direction of healthcare . Teleflex is the home of Arrow (TM) ,...* Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical… more
- CTG (Myerstown, PA)
- …delivering training in-person, virtually, and in hybrid environments. + Knowledge of regulatory compliance and FDA guidance for dissemination of medical ... Liaison (MSL) in Radiology, providing scientific and medical information to healthcare providers and researchers. + Develop and execute clinical/medical education… more
- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …Pathology and Laboratory Medicine Program at the VA Pittsburgh Healthcare System. The incumbent is primarily responsible for accessioning/processing/plating ... cultures, urine, feces, wounds, tissue, etc. advises laboratory personnel or healthcare workers on the appropriate collection and handling of specimens. assists… more
- Merck (West Point, PA)
- …and supervision on all technical issues. + Strong knowledge of cGMP, FDA , EMA, and other international regulatory requirements. + Strong analytical ... comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement… more
- University of Pennsylvania (Philadelphia, PA)
- …The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement ... review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects...and data qualify. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Clinical Research Coordinator C is… more
- University of Pennsylvania (Philadelphia, PA)
- …the lab. + Assist the Research Project Manager in submitting documents to regulatory authorities (eg IRB, FDA , etc.) and/or review/monitoring boards (ie, DSMB, ... The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …Quality Inspection of all incoming batches per current approved procedure + Support regulatory inspections ( FDA , DEA, VAWD/NABP, PADOH etc.) + Carry out other ... Warehouse activity will be preferred + Knowledge of GMP and regulatory requirements for the pharmaceutical industry. + Strong proficiency with applicable… more