- Sanofi Group (Morristown, NJ)
- …legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA / regulatory issues and fraud and abuse) as well as proposed ... pharmaceutical companies on marketing, distribution, promotion, scientific exchange, and healthcare professional interactions. This role requires efficient prioritization of… more
- J&J Family of Companies (Titusville, NJ)
- At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, ... we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact… more
- Fujifilm (Trenton, NJ)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... America Corporation, we're redefining innovation across the industries we touch-from healthcare and photography to semiconductors and data storage. With roots in… more
- Atlantic Health System (Union, NJ)
- …compliance. + Provides remediation as indicated. + Participates in in-services as required. REGULATORY COMPLICANCE (CAP, CLIA, JCAHO, FDA ) + Updates and monitors ... inquiries off hours. + Ensures that technical manuals are in compliance with all regulatory agencies. + Performs duties of testing personnel as needed. + Cover any… more
- Sanofi Group (Morristown, NJ)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more
- Sanofi Group (Morristown, NJ)
- …be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve ... possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects and/or registered… more
- Vitalief (New Brunswick, NJ)
- …is a qualifying trial per CMS regulations, and assesses compliance with other regulatory requirements, including FDA and NIH guidelines. + Negotiates budgets ... and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from. Salary Range: $80,000 to $105,000 annually depending… more
- Kedplasma (Cinnaminson, NJ)
- …with cGMP, KEDPLASMA DCOP's and other Company standards and protocols to meet regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...records and determines if records comply with SOP and regulatory requirements and ensures corrective action(s) as needed. .… more
- J&J Family of Companies (New Brunswick, NJ)
- …for marketing authorization approvals (label expansions and initial approvals) by the US FDA , as well as regulatory authorities in the EU, Asia Pacific ... At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,… more
- Fujifilm (Trenton, NJ)
- …Manager. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... by the Area Service Manager. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate...a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and… more