- United Therapeutics (Harrisburg, PA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... Conduct field rides within field regions with direct reports to evaluate regulatory compliance and abilities to deliver 'best in class' training and education + Plan… more
- BioLife Plasma Services (Pittsburgh, PA)
- …medical emergencies, applying advanced knowledge of emergency care. * Ensures compliance with regulatory standards for plasma collection and maintains detailed ... regarding donor suitability. * Maintains accurate medical documentation, ensuring compliance with regulatory standards. * Supports public health initiatives by… more
- CSL Plasma (Philadelphia, PA)
- …+ In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates vein ... (SOPs). You will report to the Assistant Center Manager **The Role** + In compliance with SOPs perform all aspects of the pheresis procedure and plasma collection,… more
- Penn Medicine (Philadelphia, PA)
- …patient/nurse safety. In partnership with Department of Regulatory Services, ensures compliance with all federal, state and local regulatory standards and ... requirements, including JCAHO, Department of Health, funding agencies, FDA , HIPAA, HCFA, DPW and others for all procedural areas. Demonstrates understanding of… more
- Globus Medical, Inc. (Audubon, PA)
- …software craftsmanship, and test-driven development. + Understanding of an FDA design control environment. + Supports manufacturing, internal testing, and ... the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United… more
- Penn Medicine (West Chester, PA)
- …for their Entity, including sourcing, advertising, interviewing, reference checking and compliance with license requirements. + Partners with managers to facilitate ... and those functions that he/she has primary accountability for are in compliance with all federal, state and local regulatory standards and requirements, including… more
- University of Pennsylvania (Philadelphia, PA)
- …assessing staff performance at all phases of orientation, assess clinical staff compliance with protocol on ongoing basis to minimize issues of non- compliance ... mission. Prepare draft PS-IDE applications for faculty review and submission to FDA . Draft components of clinical protocols and informed consents documents in… more
- University of Pennsylvania (Philadelphia, PA)
- …Perform data QC and address queries. Show vigilance in participant safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA ... as the intersection of study execution, customer service, participant safety, and overall compliance in clinical research. To this end, the proper candidate will be… more
- Brenntag AG (Reading, PA)
- …technical documentation, regulatory adherence, and internal audit processes to ensure compliance with industry standards and corporate policies. + Develop and ... and quality manuals. + Hands-on expertise with regulatory frameworks and standards such as FDA , EMA, ICH guidelines, GMP, ISO 9001, SQF, GMP+, BRC, etc. + In-depth… more
- UPMC (Pittsburgh, PA)
- …+ Maintain laboratory Drug Master Files that will be submitted to the FDA . Assist to create and maintain the Laboratory Disaster Plan. Monitor annual laboratory ... as appropriate on various committees related to safety and regulatory compliance as requested and needed. + Research regulatory requirements, prepare and… more