- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …+ Meets routinely with product -specific CS&PV team members to review and communicate product safety issues. + Reviews each product (eg, IND/NDA Periodic, ... + Serves as liaison, in conjunction with Regulatory Department, with regulatory agencies on product safety issues. + Serves as mentor and resource for CS&PV… more
- Parexel (Trenton, NJ)
- …Regulatory Authority meetings) **Literature review (as applicable)** + Review of literature for product safety assessment and potential safety issues + ... therapeutic area training), as requested, at internal and external meetings (such as investigator meetings) + Provide medical safety expertise to client per… more
- Parexel (Trenton, NJ)
- …for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in ... of clinical trials (eg enrollment, database release), to safeguard the quality of investigator sites (eg patient safety , site quality and compliance with GCP),… more
- Parexel (Trenton, NJ)
- …for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in ... of clinical trials (eg enrollment, database release), to safeguard the quality of investigator sites (eg patient safety , site quality and compliance with GCP),… more
- Sanofi Group (Morristown, NJ)
- …from health authorities, ethics committees/ IRBs, external partners + Management of product safety alerts + Ensuring the GPV's position is well ... + Provide PV and risk management expertise to internal and external customers + Safety expert for product must have an attitude of continuous learning and… more
- Sanofi Group (Morristown, NJ)
- …questions from health authorities, ethics committees, IRBs, external partners + Management of product safety alerts + Ensuring the GPE position is well ... Expert:** + Provide PV and risk management expertise to internal and external customers + Safety expert for product + Maintain knowledge of product , … more
- Sanofi Group (Morristown, NJ)
- …under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver ... of integrated development plans (IDP) + Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access… more
- Sanofi Group (Morristown, NJ)
- …under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver ... and propose related corrective action plans + Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access… more
- Munich Airport NJ LLC (Newark, NJ)
- …A. The Sprinkler Technician will maintain fire protection systems and be the first investigator for all fire alarms as well as the primary point of contact for ... violations or non-conformance issues. + Act as a first investigator for fire alarms/fire protection systems within Terminal A...the fire protection systems and FACP to ensure the safety of the terminal. + Strong problem solving and… more
- Bayer (Whippany, NJ)
- …and partners; + Support registration, market access, commercialization, and maintenance of product licenses (eg, Core Data Sheet, Periodic Safety Update Report, ... development of an endorsed Clinical Development Plan in line with the Target Product Profile, designed for successful regulatory approval and market access for one… more