- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …who contribute to product ideation, concept development, product verification, and validation , legal and regulatory compliance, demonstration of product value, and ... of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world as needed + Determining… more
- Innovation Foods LLC (Millville, NJ)
- …government requirements. Act as a liaison for regulatory compliance agencies (USDA, FDA , Kosher, Halal, and others) Coach and counsel employees when appropriate in ... relationships and associated microbiology. Must have experience with filing FDA Scheduled Processes and prior experience with process authorities and… more
- Sumitomo Pharma (Trenton, NJ)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Merck (Rahway, NJ)
- …to project / engineering work process and deliverables (eg equipment fabrication, FAT, SAT, Validation etc.) + Must be innovative and drive new ideas, but also have ... options, technology selection and regulatory posture + Demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC. Strong experience in… more
- Cytel (Trenton, NJ)
- …support for CMC-related studies, including formulation development, stability studies, process validation , and analytical method validation . + Collaborate with ... + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want our employees to succeed and… more
- System One (Park Ridge, NJ)
- …+ Sterilization & Microbiological Expertise + Lead development, optimization, and validation of sterilization processes including ethylene oxide, dry heat, gamma ... Leadership & Scientific Rigor + Oversee microbiological method development, validation , and data interpretation for regulatory submissions + Manage complex… more
- Integra LifeSciences (Plainsboro, NJ)
- …in-process and finished good products, raw materials, water, stability studies, and validation studies. This position is responsible for operating in compliance with ... all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the...for testing. + Assist as needed in test method validation , implementation, and execution. + Report any equipment and… more
- Actalent (Hackensack, NJ)
- …preparation and development of protocols, informed consent forms, monitoring plans, and validation plans. + Oversee submission of IND Applications to FDA ... as needed. + Design case report forms and liaise with data analysts for database development. + Coordinate study manuals of procedures for site coordinators, pharmacists, and laboratory technicians. + Develop and present training materials for investigators… more
- Insight Global (Edison, NJ)
- …and support) SDLC/ITIL (incident/priority/resolution) - Familiar with GxP systems, Computer System Validation and in the support of FDA regulated systems and ... business (knowing you cant plug and play just understanding) - 2-3 days on-site Warsaw, IN/Raynham, MA (prefer MA) Experience in application development and support preferred. Training with certification (Green or Black Belt) in Process and/or Design… more
- Hovione (East Windsor, NJ)
- …equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes ... by clients and health authorities, in the scope of the Qualification and Validation area - Lead functional teams or projects by coordinating and overseeing project… more