- Merck (Trenton, NJ)
- …and perform risked-based audits + Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities. + In ... alignment with risk assessments, supports the QAL in the identification of audit substrate for scheduling, as appropriate. + Ensures appropriate and timely… more
- Sumitomo Pharma (Jersey City, NJ)
- …products. + Help develop and manage timelines of publication plans of investigator -sponsored studies. + Assist in the identification , evaluation, and engagement ... drug/brand development. + Identify, initiate, coordinate, evaluate and monitor investigator -sponsored studies intended to support the clinical and scientific… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …as well as development and execution of biomarker plans as well as identification and utilization of emerging biomarker and translational tools, new technologies and ... related to direct reports in TM group. **Job Description** + Oversee identification and utilization of emerging Biomarker, Translational tools, new technologies and… more
- Bristol Myers Squibb (Madison, NJ)
- …quality data review by supporting CS team + Clinical data trend identification ; provide trends and escalate questions to Medical Monitor + Develop clinical ... of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (eg, DMC) activities + Drafting/review… more
- Bayer (Newark, NJ)
- …research projects aligned with medical and brand strategy; including facilitating investigator -initiated research (IIR) and research site identification ; + ... presentations to external audiences, stakeholders, and customers groups. Proactive identification of educational opportunities within assigned Area Business Unit to… more
- Adecco US, Inc. (Whippany, NJ)
- …national thought leaders. + Support speaker programs, advisory boards, and investigator -initiated research (IIR) site identification . + Coordinate strategic ... engagement with internal Medical Affairs and Commercial stakeholders. **Field Insights & Collaboration** + Identify medical/clinical needs and trends in the Radiology community. + Provide feedback on competitive activity and report unmet clinical needs. +… more
- Bayer (Trenton, NJ)
- …validate technical knowledge of radiopharmaceuticals' mechanisms of action and identification of imaging biomarkers in preclinical development into strategies for ... trial teams, collaborating across the organization and externally with service providers/ investigator sites; + Lead all aspects of translational studies and… more
- System One (Basking Ridge, NJ)
- …sections of Common Technical Document (CTD). Risk Management (Signal identification , evaluation, mitigation): + Support late-stage program or multiple early-stage ... + Authors or supports the development of safety sections of Investigator 's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet… more
- Ascendis Pharma (Princeton, NJ)
- …surveillance and risk management plans for drug development programs + Oversee identification and evaluation of safety signals and ensure timely escalation and ... IND Annual Reports) + Contribute to safety sections of labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions + Collaborate… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …for the study + Oversees/conducts site evaluation and selection + Leads investigator meeting preparation and execution + Monitors progress for site activation and ... cross-functional and departmental process improvement initiatives + Responsible for identification of innovative approaches to clinical study execution including… more