- Sanofi Group (Morristown, NJ)
- **Job Title:** Clinical Outcome Assessment ( COA ) Lead **Grade:** L3 **Hiring Manager:** Benoit Arnould **Location** : Cambridge, MA or Morristown, NJ (Hybrid policy ... accelerate progress. The remit of the Clinical Outcome Assessment ( COA ) team at Sanofi is to incorporate the patients'...of Clinical Outcome Assessments (COAs) and other methods. The COA team is part of Sanofi's Global Research and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Senior Clinical Outcomes Assessment ( COA ) Lead **Location:** Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... accelerate progress. The remit of the Clinical Outcome Assessment ( COA ) team at Sanofi is to incorporate the patients'...of Clinical Outcome Assessments (COAs) and other methods. The COA team is part of Sanofi's Global Research and… more
- IQVIA (Parsippany, NJ)
- **Principal, COA Strategy Consulting, Patient Centered Solutions** IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting ... team leads the industry in breadth and depth of Clinical Outcomes Assessment ( COA ) and Patient Reported Outcomes (PRO) knowledge. Our diverse team of experts works… more
- Heritage Pharma Labs Inc.d/b/a Avet Pharmaceuticals Inc. (East Brunswick, NJ)
- …to release of the material. * Once raw data is audited, he will review the accompanying COA and will sign off the COA , if required. * He will evaluate the ... results (perform 2 to 5) in SAP and then will give UD as required. * They will collect and store the raw data (folders and lab notebook) and will submit to QA for archival. * In case if there is Lab event, deviation or out of specification, the role will… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and verify expiry dates and retest dates for all GMP raw materials through vendor COA and in-house COA . + Collect packaged product samples for annual stability. ... + Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures. + Conduct in-process testing per manufacturing and packaging batch record instructions. + Prepare… more
- Bristol Myers Squibb (Summit, NJ)
- …+ Perform review of testing data (eg, data packets, final lot file, COA review). + Anticipate and perform complex troubleshooting and problem solving independently. ... + Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products. + Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts. + May represent the… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …to late phase) + Broader portfolio evidence generation strategy + Align COA endpoint development and validation work across individual assets + Drive portfolio-wide ... stakeholder strategy through external landscape & policy shaping (GA, PASM, GMA, GRA, Corporate Comms) and identify synergies with the broader CNS portfolio + Drive internal and external communication strategy + Develop and continually evolve differentiated… more
- L'Oreal USA (Piscataway, NJ)
- …Meticulously review production records and components Certificates of Analysis ( COA ), conduct audits, and champion Good Manufacturing and Laboratory Practices ... (GMP/GLP) to ensure all documentation is accurate and audit-ready + Collaborating for Excellence: Partner with production teams to investigate quality issues, using your problem-solving skills to find root causes and implement lasting solutions. We Are Looking… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …dates for GMP raw materials using vendor and in-house Certificates of Analysis ( COA ). + Collect packaged product samples for annual stability studies. + Conduct ... room, equipment, and packaging line checks before each manufacturing stage. + Perform in-process testing as per manufacturing and packaging batch record instructions. + Prepare finished product samples for QC lab and QA retains, following documentation… more
- IQVIA (Parsippany, NJ)
- …for descriptive and comparative research using RWD (examples include claims, EHR, PRO/ COA , registry data) for methodologic research questions. + Lead the design and ... execution of post-marketing and observational safety studies to evaluate product risk profiles and inform regulatory and clinical decision-making. + Contribute to engagements with regulatory authorities to provide scientific input, respond to safety-related… more
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