- Pfizer (Collegeville, PA)
- …investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents. + Provide leadership to early stage clinical scientists ... with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists. Meet regularly with the Pfizer Oncology group… more
- Penn Medicine (Philadelphia, PA)
- …Focus energy on collaboration and not blame Support Established Workflow and Regulatory Documentation: Building work practices and team processes compliant with ... regulatory requirements and program goals and initiatives Ensures adequate...and concerns, electronic and medical record documentation processes Ensure Regulatory Compliance: In Partnership with Program leadership, ensure compliance… more
- Penn Medicine (Philadelphia, PA)
- …teaching functions with residents/fellows, Medical Laboratory Science and other students. Regulatory Compliance: Works with the Division's Quality Assurance manager ... in functioning as liaison to accrediting / regulatory agencies in preparation for inspections, site visits, documentation of compliance, deficiency corrections,… more
- Penn Medicine (Philadelphia, PA)
- …the Division's Quality Assurance manager in functioning as liaison to accrediting/ regulatory agencies in preparation for inspections, site visits, documentation of ... Federal, State, and local government agencies and professional accrediting agencies' regulatory requirements impacting lab operations including AABB, CMS (Center for… more
- Penn Medicine (Philadelphia, PA)
- …teaching functions with residents/fellows, Medical Laboratory Science and other students. ** Regulatory Compliance** : + Works with the Division's Quality Assurance ... manager in functioning as liaison to accrediting / regulatory agencies in preparation for inspections, site visits, documentation of compliance, deficiency… more
- Penn Medicine (Berwyn, PA)
- …supervision and direction in regards to all administrative, financial, regulatory , quality, human resources, patient/employee satisfaction, and clinical aspects for ... resident program), special clinical programs, multiple clinical specialties, complex regulatory requirements, management of external partnerships/collaborations. Ensures management of… more
- Brenntag AG (Reading, PA)
- …external auditing programs to ensure that all operations meet the strict regulatory , industry, and corporate standards unique to these highly regulated sectors. The ... necessary updates of the regional quality manual, ensuring it reflects current regulatory standards, industry best practices, and operational needs. + Develop and… more
- Merck (West Point, PA)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- Sumitomo Pharma (Harrisburg, PA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- UGI Corporation (Denver, PA)
- …annual LIURP budgets, through ongoing management and reporting compliant with regulatory requirements, this role will coordinate all internal and external resources, ... program metrics. Additionally, this role is responsible for managing and supporting all regulatory filings that involve LIURP such as Base Rate Case Filings and… more