- Integra LifeSciences (Plainsboro, NJ)
- …and implement calibration procedures to ensure equipment meets performance and regulatory requirements. + Analyze calibration results and provide accurate reports ... of calibration activities, adhering to Good Laboratory Practices (GLP) and regulatory requirements. + Collaborate with laboratory personnel to support technical… more
- Sanofi Group (Morristown, NJ)
- …patient safety/pharmocovigilance, patient focused drug development, portfolio management, global regulatory and digital partners to foster innovation and ensure best ... digital biomarkers.Cultivaterepresentation of Sanofi at key industry conferences (eg DIA, FDA industry workshop) and academic forums. + Establish and maintain… 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
- Sanofi Group (Morristown, NJ)
- …contribution of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health authorities + ... with R&D and Clinical Development teams to write, review, edit, and approve key regulatory documents + Engage Key External Leaders (KOLs) to apply for support for… more
- Kelly Services (Mahwah, NJ)
- …document related changes in accordance with change management procedures and relevant regulatory requirements for medical devices. This role will be a key player ... business activities while remaining compliant with applicable internal and external regulatory requirements including but not limited to Site, Division, Corporate, … more
- Sanofi Group (Morristown, NJ)
- …Safety and Pharmacovigilance (PSPV) and country PV offices in anticipation of regulatory inspections and audits. + Active involvement in the preparation, conduct, ... and follow-up of GxP regulatory inspections impacting PV until closure. + Active involvement...knowledge of International (ICH/CIOMS), EU (Good PV practices), and FDA regulations in the domain of Pharmacovigilance. + Fluent… more
- Penn Medicine (Cherry Hill, NJ)
- …methods as required). + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, ... etc) Change Management: + Flexible and readily adopts new processes and is engaged in practice operation changes. Education or Equivalent Experience: + HS Diploma/GED AND 2+ years medical office experience OR 2+ years customer service experience required.… more
- Novo Nordisk (Plainsboro, NJ)
- …Ensures all programming is done compliantly, with close partnerships with legal, regulatory , compliance and medical + Pipeline Communications + Accountable for the ... directing US media and advocacy strategies for Food & Drug Administration ( FDA ) advisory committee meetings + Measurement + Designs and delivers initiatives with… more
- Penn Medicine (Somers Point, 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
- Bristol Myers Squibb (Summit, NJ)
- …in ensuring workplace safety, employee health protection, and compliance with regulatory standards. The ideal candidate will have comprehensive experience in both ... compounds, and high-containment processes. + Ensure compliance with OSHA, ACGIH, NIOSH, FDA , and other applicable health and safety regulations and guidelines. +… more