- Actalent (Piscataway, NJ)
- Job Title: Quality Assurance and Regulatory Affairs SpecialistJob Description As a Quality Assurance and Regulatory Affairs Specialist, ... as a team, and transcending what is possible. + Support Regulatory Affairs and Quality Assurance management as needed. + Perform all other duties as… more
- Bayer (Whippany, NJ)
- …Product Development, as well as executives in Marketing, Sales, Manufacturing, Drug Safety, Quality Assurance , Regulatory Affairs and Legal Departments; ... identified and shared with key internal stakeholders; + Assists in any designated quality assurance review program. Ensures that information systems used by… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …development products by closely working with MTP internal colleagues in various functions ( Quality Assurance , Regulatory Affairs , Marketing, Market ... + Collaborates effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance , Regulatory Affairs , Finance, etc. of Mitsubishi… more
- J&J Family of Companies (Raritan, NJ)
- …continuous improvement. **Stakeholder Collaboration:** + Work closely with cross-functional teams, including Quality Assurance , Regulatory Affairs , and ... compliance frameworks. **Data Management:** + Establish protocols for data integrity, quality assurance , and validation to support compliance objectives. +… more
- J&J Family of Companies (Raritan, NJ)
- …and methodologies. **Cross-Functional Collaboration** + Collaborate with cross-functional teams, including Quality Assurance , R&D, and Clinical Affairs , to ... talent for a **Senior Manager, Data Analytics & Insights** to support the Regulatory Affairs Data Office. **Purpose** : This role will lead the development of a… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational...quality assurance , etc.) in pharmaceutical or healthcare… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **JOB SUMMARY** The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to ... SM) and relevant external stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient… more
- Veterans Affairs, Veterans Health Administration (New York, NY)
- …is integrated with other services' function. The incumbent performs process improvement, quality assurance and administrative functions as requested that are ... etc; specialized areas of a complex nature such as nuclear pharmacy, quality assurance , pharmacy informatics, clinical applications coordinator, Home Based… more
- Danaher Corporation (New York, NY)
- …to maintain labeling integrity. + Collaborate with internal stakeholders: Work closely with Regulatory Affairs , Quality Assurance , and Manufacturing ... and improve human health. This position is part of Quality Assurance and will be remote with...and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs , and Marketing, to develop labeling… more
- Bausch + Lomb (Trenton, NJ)
- …B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance , Pharmacovigilance/GPSS ... ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house… more
- System One (Florham Park, NJ)
- …electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance , to obtain ... work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance... regulatory affairs , clinical operations, and quality assurance in a team-oriented environment. +… more
- Citigroup (New York, NY)
- …of and help anticipate regulatory concerns. + Review and provide quality assurance of risk management deliverables submitted to regulators. + Support ... also provides opportunity to support the development of the new regulatory affairs model across the broader risk management team. **Qualifications:** + 10+… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in relevant training programs. + Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance. + Keep abreast of ... and that technology-related audits are conducted. + Oversee and guide quality assurance processes related to project specifications, ensuring standard… more
- Sanofi Group (Morristown, NJ)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... that leverage digital technologies for advanced research opportunities. **Compliance and Quality Assurance ** + Accountable for ensuring all evidence generation… more
- J&J Family of Companies (Titusville, NJ)
- …regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical ... supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs , clinical pharmacology, clinical… more
- American Express (New York, NY)
- …of and experience with enterprise / operational risk management processes including regulatory exam management / regulatory affairs , issues management, ... has a Professional Practices group responsible for managing audit operations, quality , and standards; regulatory relations; reporting; training and professional… more
- Wolters Kluwer (New York, NY)
- …processes and develop new processes. + Support external and internal audits; represent Quality Assurance as a subject matter expert. + Assure integration and ... device software launches and market expansions. **Post-Market Surveillance and Regulatory Affairs ** + Coordinate post-market activities including surveillance,… more
- General Motors (Trenton, NJ)
- …Regulatory Lead, you will report to the Head of AV Safety Strategy and Assurance and lead regulatory efforts related to AV behavior, including traffic law ... compliance and performance standards. You'll collaborate with Legal, Government Affairs , and regulatory experts to ensure compliance, influence future… more
- J&J Family of Companies (Titusville, NJ)
- …Clinical Team. Team matrix interactions may include project management, finance, legal, quality assurance , quality monitoring & compliance, clinical supplies ... unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics,...team and be responsible for timely completion, content and quality of key documents eg clinical development plans, protocol… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …, Pharmacovigilance, Health Economics & Outcomes Research, Generics, and Clinical Quality Assurance . + Develop, maintain and deliver communications and ... and experience working with Clinical and Pre-Clinical Research, Generics, Medical Affairs , Pharmacovigilance, Health Economics & Outcomes Research, Regulatory ,… more