- Merck (Rahway, NJ)
- …preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions. The successful ... skills, multi-tasking, oral and written communications skills. **Education Minimum Requirements:** PhD in Analytical Chemistry or related discipline or MS in… more
- Merck (Rahway, NJ)
- …partners and/or vendors. **Core Skills:** + Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH) + Ability to manage multiple competing ... clinical drug development, project management, and/or medical field experience or PhD /PharmD Degree Degree in life sciences, preferred. -15% Travel Current Employees… more
- L'Oreal USA (Clark, NJ)
- …developing comprehensive technical dossiers. Meticulously compiling test results, data analysis , and scientific interpretations, you ensure the information is both ... ultimately validating the product's efficacy and safety. + Navigating the Global Regulatory Landscape: You collaborate with Product Safety, Regulatory , and… more
- L'Oreal USA (Clark, NJ)
- …developing comprehensive technical dossiers. Meticulously compiling test results, data analysis , and scientific interpretations, you ensure the information is both ... ultimately validating the product's efficacy and safety. + Navigating the Global Regulatory Landscape: You collaborate with Product Safety, Regulatory , and… more
- Merck (Rahway, NJ)
- …engagements. This includes the ability to: + Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH) + Ability to manage multiple competing ... clinical drug development, project management, and/or medical field experience OR PhD /PharmD Degree in life sciences, preferred. **Ideal candidate would have:** +… more
- Abbott (Princeton, NJ)
- …providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an ... maximize execution of strategic initiatives. . Ensures team member adherence to regulatory and compliance guidelines in all aspects of scientific dissemination of… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …upstream process technology transfers to CDMOs, including documentation review, gap analysis , and risk assessment. + Provide expert technical oversight of upstream ... and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. +… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification ... + Lead complex manufacturing investigations and deviations, ensuring thorough root cause analysis and effective CAPA implementation at CDMOs. + Drive strategies for… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve ... prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV)… more
- UNUM (Trenton, NJ)
- …today! **General Summary:** This position is responsible for providing expert medical analysis of claims files (or underwriting applications) across Unum US product ... services to the Benefits Center. The Medical Consultant adheres to current regulatory , claim process, and internal workflow standards as set forth in the… more