- Sanofi Group (Morristown, NJ)
- …+ Contribute to the clinical part of Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc.) and answer to questions from health ... leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy… more
- Stryker (Mahwah, NJ)
- …work across multiple manufacturing sites and collaborate closely with R&D, Manufacturing, Quality , Regulatory , and Supply Chain to deliver projects that meet ... MIM processes, tooling, materials, and manufacturability considerations. + Ensure compliance with FDA , ISO 13485, and internal quality system requirements. +… more
- J&J Family of Companies (Raritan, NJ)
- …global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers + Experience with ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Assurance **Job Category:** People… more
- Integra LifeSciences (Princeton, NJ)
- …complete product solutions to the market. + Engage with R+D, Marketing, Quality , Regulatory , Planning, Medical Safety, Procurement and Manufacturing groups to ... for the function, determining skill needs, talent acquisition, adherence to quality processes, performance management, staff development, and allocation of resources… more
- Atlantic Health System (Summit, NJ)
- …compliance. + Provides remediation as indicated. + Participates in in-services as required. Regulatory Compliance (CAP, CLIA, JCAHO, FDA ): + Updates and monitors ... reports workload statistics to the Site Manager. + Reports Quality Control, Proficiency Testing and Quality Improvement...Ensures that technical manuals are in compliance with all regulatory agencies. + Performs duties of testing personnel as… more
- Bristol Myers Squibb (Princeton, NJ)
- …a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, ... and external signals, leveraging these insights to anticipate regulatory expectations, shape enterprise-wide inspection readiness strategies, and drive proactive,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and platform operations, and partners closely with Biostatistics, Clinical Operations, Regulatory , and Quality to ensure compliant, efficient, and scalable ... high- quality statistical programming solutions for clinical trials and regulatory submissions. + Set clear goals, conduct performance assessments, and foster… more
- BeOne Medicines (Pennington, NJ)
- …drug preclinical, clinical and commercial requirements. + Familiarity with EMA and FDA regulatory requirements for submissions. + Effective communication, oral ... This position involves close collaboration with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory , Process Development… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Lead, Clinical Scientist. and other functional areas such as GCO, biostats, regulatory , pharmacovigilance. The Director will be a key contributor to INDs, NDAs, ... BLAs, and other global regulatory filings and publications. The Director will foster relationships...during clinical trial conduct to identify trends and ensure quality data for database locks and interim cuts. +… more
- Sanofi Group (Morristown, NJ)
- …clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA) and answers to questions from health ... scientists in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to deliver development… more