- Sanofi Group (Morristown, NJ)
- …Audit and Inspection Readiness team as an Expert. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve ... Safety and Pharmacovigilance (PSPV) and country PV offices in anticipation of regulatory inspections and audits. + Active involvement in the preparation, conduct,… more
- Sanofi Group (Bridgewater, NJ)
- **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company ... submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China...for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the… more
- Sumitomo Pharma (Trenton, NJ)
- …and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …of action and drug landscape as well as maintaining compliance in accordance with FDA , EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical ... Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve… more
- Sumitomo Pharma (Trenton, NJ)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more
- Integra LifeSciences (Plainsboro, NJ)
- …chance to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... and implement calibration procedures to ensure equipment meets performance and regulatory requirements. + Analyze calibration results and provide accurate reports… more
- J&J Family of Companies (Raritan, NJ)
- …Good working knowledge and understanding of medical device regulations, standards, and regulatory bodies, eg FDA (Food and Drug Administration), ISO ... 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
- J&J Family of Companies (Raritan, 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
- 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
- IQVIA (Trenton, NJ)
- …(samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. + Maintains accountability for all pharmaceutical ... samples in accordance with FDA and PDMA guidelines. + Utilize the sales automation...global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare… more