- Charles River Laboratories (Wayne, PA)
- …client visit and regulatory inspection find.ings. + Provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of ... of a variety of processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures. In the… more
- Pfizer (Collegeville, PA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong… more
- Constellation (Kennett Square, PA)
- …+ Strong written and oral communication skills + Approval of VP Licensing & Regulatory Affairs required to obtain this classification (and recommendation of Sr. ... includes bonus and 401(k). **PRIMARY PURPOSE OF POSITION** Performs advanced regulatory /technical problem solving and provides analysis/insights in support of plant… more
- Merck (North Wales, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be… more
- Merck (Harrisburg, PA)
- …immunology, neurology, cardiometabolic and others as needed by the pipeline. + Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- UPMC (Johnstown, PA)
- …Assists at other UPMC Radiation Oncology locations if the need arises. + ** Regulatory Affairs Management** : Participates in regulatory compliance activities ... and maintains continuous departmental readiness for inspections and surveys. Follows all radiation safety standards. Wears radiation monitoring badge and ID badge at all times. Remains HIPAA compliant at all times. Completes clinical competencies annually as… more
- Envista Holdings Corporation (Quakertown, PA)
- …Quality Management System (QMS). The position will work together with Regulatory Affairs , Engineering, Operations, and Purchasing/Procurement to ensure product ... growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced… more
- UPMC (Williamsport, PA)
- …+ Use effective communication and interpersonal skills to explain treatment-related procedures. Regulatory Affairs Management + Participate in regulatory ... compliance activities to maintain departmental readiness for inspections and surveys. + Adhere to radiation safety standards; wear radiation monitoring and ID badges at all times. + Maintain HIPAA compliance. + Complete annual clinical competencies as… more
- Merck (West Point, PA)
- …teams, including research and development, regulated bioanalytical, clinical research, regulatory affairs , and quality assurance, to provide scientific ... vaccine bioanalytical outsourcing, ensuring alignment with corporate objectives and regulatory requirements. The Senior Director will oversee a multidisciplinary… more
- Legrand NA (Canonsburg, PA)
- …accountability and excellence. + Cross-functional collaboration:Partner with Quality Assurance, Regulatory Affairs , and other departments to coordinate ... role ensures that all controlled documentation is accurate, accessible, compliant with regulatory standards, and aligned with company goals. As a key stakeholder,… more