- RWJBarnabas Health (Long Branch, NJ)
- …that all IRB activities and documents are in compliance with OHRP and FDA regulations + Attends local and national conferences and seminars and other ... requested by the Chair and Senior Research Administrator to keep abreast of regulatory and legislative requirements related to research + Facilitate and maintain IRB… more
- Penn Medicine (Voorhees, NJ)
- …self and assigned area(s) are compliant with all applicable federal, state, and local regulatory standards (ex OSHA, TJC, DOH, FDA , HIPAA, etc.) + Oversees the ... + Clinical Care Associates (CCA) MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more
- Penn Medicine (Voorhees, 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. Education or Equivalent Experience: + Required: + HS Diploma/GED + 2+ years of medical office experience, or 2 years of customer service experience. (Advanced degrees… 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
- 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
- Integra LifeSciences (Plainsboro, NJ)
- …and Drug Administration and DOT/IATA, ISO 13485, and other applicable regulatory agencies. **SUPERVISION RECEIVED** Under direct supervision of the Warehouse ... required logs, books, records, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …of the Clinical Study Reports and may support the development of regulatory documents; may perform quality review + Maintains compliance in accordance with ... FDA , EMEA, ICH and GCP guidelines as well as...& medical writing skills. Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. Proven track in clinical… more
- Vitalief (Livingston, NJ)
- …and issue correspondence reflecting IRB deliberations and decisions. + Provide regulatory and methodological guidance to investigators, staff, students, and IRB ... members. + Maintain compliance with OHRP, FDA , ICH/GCP, and institutional regulations. + Manage IRB databases, tracking systems, and protocol documentation. + Assist… 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
- Norstella (Trenton, NJ)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... and education materials regarding benefits offerings, wellness programs, and regulatory requirements (eg, ACA, HIPAA, ERISA). + Collaborate with Payroll,… more