- Penn Medicine (Plainsboro, NJ)
- …to the staff, and develop/implement action plans to improve performance. + Regulatory Compliance: (In partnership with Leadership Team). + Ensures compliance with ... all federal, state and local regulatory standards and requirements, including TJC, Department of Health,...and requirements, including TJC, Department of Health, funding agencies, FDA , HIPAA,and others. + Identify the competencies required for… more
- BeOne Medicines (Pennington, NJ)
- …and vendor qualification. + Development of all necessary SOPs, ensuring regulatory compliance in conjunction with being appropriate both clinical and commercial ... or adverse events requiring documented review and action. + Participation in regulatory and customer inspections/audits. + Subject matter expert in GMPs: 21 CFR… more
- Penn Medicine (Atlantic City, NJ)
- …/ Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... + Flexible and readily adopts new processes and engages in practice operation changes. + Access Center Responsibilities (if appropriate): + Coordinates clinical and administrative aspects of the new patient scheduling encounter. + Perform within the expected… more
- Sokol Materials & Services (Skillman, NJ)
- …integrity principles + Proven attention to details + Comfortable working in an FDA regulated environment. About the Role DUTIES AND RESPONSIBILITIES: * Provide QA ... decisions on non-conformances using a solid understanding of Quality Systems and regulatory requirements. * Review and approve documents related to Quality, Quality… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …understanding of important topics including clinical trial design, drug development, regulatory decision making and public policy. . Responsible for comprehensive ... education programs, as well as planning around key data announcements, regulatory milestones and launch planning for late-stage pipeline candidates. . Maintain… more
- RWJBarnabas Health (West Orange, NJ)
- …radiology emergency on-call program. Staff assists management in meeting regulatory requirements and department/organizational goals. Performs other duties as ... + Assist Manager in maintaining and fulfilling the department/organization's regulatory requirements and goals. Complies with system, hospital and departmental… more
- Sanofi Group (Morristown, NJ)
- …a manner that advances the company's strategy while addressing legal and regulatory risks and preserving and protecting the company's integrity and reputation. The ... highly valued. Ability to identify potential legal issues (focusing on promotional matters, regulatory issues, and fraud and abuse) as well as proposed solutions to… more
- BioLife Plasma Services (Trenton, NJ)
- …gain hands-on experience in operational production, including financial, regulatory , administrative, marketing, quality, facilities, and people management. Gain ... customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and Employee… more
- Taiho Oncology (Princeton, NJ)
- …concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance. + Responsible for ... safety reports. + Provides medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc. + Chairs the GSMT for responsible… more
- Sanofi Group (Bridgewater, NJ)
- …the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions ... development strategies for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project… more