- 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
- 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
- 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
- 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
- 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
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Medical Director, Clinical Sciences is responsible for facilitating assigned studies, providing investigator support of Regeneron driven studies, and may serve as a ... study design and research methodology as well as understand Regulatory and compliance landscape in the pharmaceutical industry. This role utilizes scientific and… more
- IAHD-Institute for Applied Human Dynamics (Tarrytown, NY)
- …Services or a related field + 3+ years of experience in quality assurance, compliance , or investigations in human services + Completion of OPWDD Investigator ... Training (or willingness to obtain) and must remain certified thereafter + Strong organizational, analytical, and written communication skills + Proficiency with Microsoft Office, IRMA, and WSIR systems + Deep understanding of OPWDD, NYS Justice Center, and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. **In this role, a typical day might include the ... amendments and information requests, Orphan drug applications, Annual Reports and Investigator 's Brochure + Assist in coordination and preparation for Agency… more