- University of Pennsylvania (Philadelphia, PA)
- …ongoing protocol training/compliance meetings. Adheres to all University and other regulatory guidelines. The clinical trials will be conducted at Penn Presbyterian ... for reports, meetings, presentations, and response to sponsors. 5) Regulatory submissions inclusive of modifications and continuing reviews. Hybrid Eligible… more
- University of Pennsylvania (Philadelphia, PA)
- …well as completion of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance visits. + Assure ... compliance with the protocol and regulatory requirements includes collecting, recording, and maintaining data and...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- University of Pennsylvania (Philadelphia, PA)
- …This position requires significant dedication and resilience to acquire and apply regulatory knowledge with the duty to protect research patient safety and data ... requires significant dedication and resilience to acquire and apply regulatory knowledge with the duty to protect research patient...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- University of Pennsylvania (Philadelphia, PA)
- …with clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that Standard Operating Procedures (SOPs), ... Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously....allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- University of Pennsylvania (Philadelphia, PA)
- …Cardiology Clinical Research Unit (CCRU), overseeing clinical trial operations, regulatory compliance, research staff, and strategic program development across Penn ... across studies to meet enrollment and performance goals. + Regulatory & Quality Management -Oversee regulatory submissions...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- Merck (Montgomery County, PA)
- …collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will ... case management. + Act as **primary liaison** with commercial, medical affairs , market access, legal/compliance, pharmacovigilance, and external partners to ensure… more
- University of Pennsylvania (Philadelphia, PA)
- …have prior experience conducting clinical research while adhering to applicable regulatory policies for patient and data protection. Responsibilities include, but ... ensuring patient accommodation and relationship-building for longitudinal assessment; 4) Regulatory preparation and submission; and assisting with audit preparation… more
- University of Pennsylvania (Kennett Square, PA)
- …to ensure compliance with university and Governmental policies. Participate in regulatory agency inspections and follow up with compliance issues. Job Description ... and/or administration of medication and/or drug compounds. + Participate in regulatory agency animal inspections and coordinate improvement issues. + Coordinate and… more
- University of Pennsylvania (Philadelphia, PA)
- …* Attends study related meetings * Assists in obtaining appropriate signatures for regulatory forms * Assists in the preparation of documents needed for initiation, ... complete case report forms * Assists in preparation and submission of regulatory documents (including continuing review, amendments, and adverse event reporting) to… more
- University of Pennsylvania (Philadelphia, PA)
- …Job Responsibilities + Assist in the preparation and submission of regulatory documents (including continuing reviews, amendments, and adverse event reporting) to ... (IRB). + Assist in the preparation and processing of regulatory documentation with pharmaceutical companies and CROs. + Assist...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more