- Actalent (Allendale, NJ)
- …responsible for writing and completing investigations and deviations from a compliance and operations perspective. This role involves conducting root cause analyses ... investigations, from initiation to closure, to ensure manufacturing and GMP compliance . Responsibilities + Determine the causes and preventative actions of… more
- ManpowerGroup (Wayne, NJ)
- …a leading organization in the medical device industry, is seeking a dedicated Complaints Investigator to join their team. As a Complaints Investigator , you will ... part of the Quality Assurance department supporting product safety and compliance initiatives. The ideal candidate will demonstrate strong analytical skills,… more
- MVP Health Care (Tarrytown, NY)
- …thinking and continuous improvement. To achieve this, we're looking for a **Clinical Investigator ** to join #TeamMVP. This is the opportunity for you if you have ... a passion for problem solving and investigations, commitment to compliance and ethical standards and dedication to continuous learning and improvement. **What's in… more
- Abbott House (Irvington, NY)
- …a Continuous Quality Improvement approach. This person will also ensure programs' compliance w/agency policies and government regulations from NYS OPWDD, JC, DOH, ... strengthen program operations. + Ensure that agency is in compliance with all Federal, OPWDD, OMIG, OMH, DOH and...and work independently + Candidate must possess a current Investigator Certificate from the Justice Center, OPWDD or OMH.… more
- Tompkins Community Bank (Brewster, NY)
- …with internal teams to enhance fraud mitigation strategies and ensure compliance with applicable regulations. Responsibilities + Supervise and conduct quality ... actions, including SAR/No SAR filings, ensuring accuracy, timeliness, and regulatory compliance . + Monitor and evaluate internal controls related to fraud detection… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …Manager, a typical day may include:** + Act as the lead investigator on employee concerns including devising investigation strategies, reviewing data and documents, ... managers. + Partner effectively with HR Business Partners, the legal team, Compliance , Quality Assurance, Security and others. + Collaborate with compliance … more
- YAI (Westchester County, NY)
- …Hudson Valley Region* Key/Essential Functions & Responsibilities + Acts as the primary investigator for all incidents reported to the NYS Justice Center for assigned ... requirements beyond MQRs above) + Master's degree in human services, business, compliance , or a related field + Previous experience conducting investigations in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …documents such as: regulatory agency briefing books, IND/IMPD submissions, investigator 's brochure, informed consent forms, IRB/IEC submissions, clinical study ... of trial - Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy,… more
- Touro University (Valhalla, NY)
- …strong interest in neuroscience and energy balance. Supervised by the Principal Investigator (PI), the ideal candidate will assist in conducting experiments and ... and other duties as assigned. Responsibilities + Assist the Principal Investigator (PI) with experimental design, execution, data collection, and interpretation. +… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …several of our External Sponsored Research (ESR) programs including Investigator -Initiated Studies (IIS) and Research Collaboration (RC). Responsibilities will also ... activities, timelines, and key deliverables, budgets, forecasting, disclosures, and compliance + Support of Late-Stage Molecules, and launch readiness activities… more
- IQVIA (Parsippany, NJ)
- …study teams, external partners, and internal stakeholders. Your work ensures compliance , efficiency, and a positive experience for trial participants. **Key ... to ensure services are delivered on time, within budget, and in compliance with sponsor SOPs, ICH-GCP, and local regulations. + **Participant Support Services:**… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Trial Management System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical trial registry requirements + Identifies outsourcing needs of ... for the study + Oversees/conducts site evaluation and selection + Leads investigator meeting preparation and execution + Monitors progress for site activation and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …of the Clinical Publisher (Clinical Publisher) are to ensure the accuracy and compliance of clinical documents including but not limited to clinical study protocols, ... clinical study reports, investigator 's brochures, and summary modules for regulatory submissions. This...(protocols, IBs, DSURs, CSRs, summary documents, and others) in compliance with regulatory guidelines and internal SOPs + Ensures… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …concept development, product verification, and validation, legal and regulatory compliance , demonstration of product value, and stakeholder education. In addition, ... Standard Operating Procedures to optimize MA functioning in terms of leadership, compliance and productivity. The Director, Medical Affairs, will drive the clinical… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …reporting of Medical Affairs studies, ensuring scientific integrity, regulatory compliance , and alignment with strategic priorities. Provides mentorship and guidance ... in the MASH therapeutic area. + Leads prioritization and support for investigator -initiated studies, serving as a key decision-maker and member of internal… more
- Hackensack Meridian Health (Hackensack, NJ)
- …clinical research operations are managed, tracked, and reported according to investigator , sponsor, departmental, NCI, and HMH requirements and maintaining full ... regulatory compliance at all times. In addition, this role is...process improvement and assures clear communication, process documentation, and compliance with Good Clinical Practices and procedures. **Education, Knowledge,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …amendment, and routine submissions (eg, Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.). + Oversees and approves the authoring of ... resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets. + Ensures own work… more
- IQVIA (Parsippany, NJ)
- …leaders and interfacing with internal and external stakeholders to ensure compliance , quality, and timely delivery of trial milestones. **Key Responsibilities:** ... Labs, ePRO, Imaging, Translation, and Ancillary Supplies. **Documentation & Compliance ** + Create and maintain trial-specific documents (eg, Monitoring Guidelines,… more
- Mount Sinai Health System (Montebello, NY)
- …healthy work environment by following standards and procedures and in compliance with legal regulations. + Complies with established personal protective equipment ... of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's… more
- Pfizer (Pearl River, NY)
- …and regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation ... support (DSUR, PBRER) submission disclosure deliverables and product defense. + Ensures compliance with internal SOPs and external regulatory standards. + Review IIR… more