- Penn Medicine (Philadelphia, PA)
- …Continuously improve unit/department operations to maintain and exceed internal/external regulatory compliance and achieve clinical excellence. * Participates in and ... staff. * Identify unit quality metrics, review and track regularly. * ** Regulatory Compliance (In partnership with Leadership Team):** Ensures compliance with all… more
- Pfizer (Collegeville, PA)
- …analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions. + Provides statistical input to study designs and can ... collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to...of experience in clinical trials. High aptitude in: * FDA /EMA and other regulations * ICH GCP guidelines *… more
- Penn Medicine (Philadelphia, PA)
- …Continuously improve unit/department operations to maintain and exceed internal/external regulatory compliance and achieve clinical excellence. Participates in and ... to capture patient safety trends.Supports the Nurse Manager in ensuring regulatory compliance:(In partnership with Leadership Team) Ensures compliance with all… more
- Envista Holdings Corporation (Quakertown, PA)
- …growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced ... role will work cross-functionally with other business areas including Regulatory , Marketing, Quality Control, Operations, etc. to drive innovation...+ Experience in Design Control/ DFM / GMP / FDA / ISO 9001/ ISO 13485 standards + Experience… more
- University of Pennsylvania (Philadelphia, PA)
- …mission. Prepare draft PS-IDE applications for faculty review and submission to FDA . Draft components of clinical protocols and informed consents documents in ... collaboration with faculty. + Regulatory -Financial-Training/Continuing Education: Negotiate clinical trial agreements and budgets; conduct study initiation;… more
- Norstella (Harrisburg, PA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- University of Pennsylvania (Philadelphia, PA)
- …Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, initial ... responses to IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute to Informed Consent… more
- Sumitomo Pharma (Harrisburg, PA)
- …using SAS + Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc. + Executing Pinnacle ... 21 Checks + Knowledge about CDISC and Regulatory Guidelines + Demonstrate coaching skill to mentor Statistical...to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge… more
- J&J Family of Companies (Malvern, PA)
- …+ Author or coordinate appropriate IND/IMPD/BLA/MAA sections & interact with regulatory agencies to address product characterization related inquiries. + Effectively ... + Stay up to date with industry standards, guidelines, and regulatory requirements related to Advanced therapies, comparability studies and product characterization.… more
- US Tech Solutions (Easton, PA)
- …business and operations. + Prepare for and support internal and external regulatory inspections and audits. + Lead the development, revision, and lifecycle ... and related controlled documents. + Interact as needed with the FDA and other governmental inspection agencies, ensuring accurate, professional representation of… more