- Novo Nordisk Inc. (Plainsboro, NJ)
- …A minimum of 5 years' experience required (Pharmaceutical industry, laboratory, or clinical research experience) An intermediate to advanced proficiency in ... About the Department The Clinical , Medical and Regulatory (CMR) department...including tracking and maintaining the Submissions Plan update. Consolidates research and gathers Novo Nordisk opinions/position (eg FDA draft… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... to Alzheimer's disease (AD) or mild AD. TheNeurology Account Specialist (NAS) will be part of a diverse team...the primary role of demand generation by conveying complex clinical information to customers and key stakeholders consistent with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of ... global function on study and project teamsProduces independent writing for publications and regulatory documentsServes as a specialist in PK-PD and Pop PK-PD… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality support in clinical manufacture or NPI is preferred. Experience in clinical quality, method development, cell banking, or Research & Development is ... Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in...materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and ... study and project teamsProduces independent writing for publications & regulatory documentsServes as a specialist in PK-PD...in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years… more
- Merck & Co. (Rahway, NJ)
- …Sterile Operations Equipment Operation Engineer will serve as a primary operations specialist within in the FLEx Sterile GMP Clinical Manufacturing facility.To ... systemsExperience with new GMP facility startup.Knowledge of Investigational drug regulatory requirements.Comprehension of Clinical Supply Chain Operations.Experience… more
- Piper Companies (Philadelphia, PA)
- Piper Companies is currently seeking a Regulatory Affairs Specialist , Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an ... innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist , Cell & Gene TherapyCoordinate and… more
- Fenway Health (Boston, MA)
- …nursing student placement in clinical rotations Support Nursing department clinical needs/ duties as assignedResearch Integrates relevant research outcomes ... the guidance of the Director of Nursing, Nursing Professional Development Specialist is responsible for leading professional development initiatives to promote … more
- UCHealth (Loveland, CO)
- …applicant's relevant experience The UCHealth Research Administration Program is seeking a Clinical Research Regulatory Specialist . This position will ... Preferred candidates will have experience in supporting the conduct of clinical research , regulatory processing and submissions involving central IRBs and… more
- University of Pennsylvania (Philadelphia, PA)
- …Title Veeva Quality Assurance Specialist (Abramson Cancer Center) Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary ... the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in...CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to… more
- University of Colorado (Aurora, CO)
- … Support Team (CReST) has an opening for a full-time Clinical Research Startup Specialist to provide regulatory and operationalization startup support ... Clinical Research Startup Specialist ...initial site selection through budget negotiation, operationalization, organizational and regulatory approvals, and site activation. + Proactively seeks guidance… more
- Dignity Health (Phoenix, AZ)
- …the daily operation and supervision of the Clinical Research Regulatory Affairs area and program specialist (s) in accordance with all applicable ... trial sponsors. Responsibilities Include: + Manages all functions of the Clinical Research Regulatory Affairs team with minimal input and supervision from… more
- Rockefeller University (New York, NY)
- …information,please see the hospital website at: http://www.rucares.org/ Overview The Clinical Research Specialist serves as a regulatory expert and ... Clinical Research Support Office in the Hospital. Responsibilities The Clinical Research Specialist conducts internal for-cause/not-for-cause and new… more
- University of Pennsylvania (Philadelphia, PA)
- …study visits and regulatory compliance in one or more studies. Clinical Research Coordinator work includes study design, protocol development, submission to ... require working off site and flexible hours. Clinical Research Coordinator B will assist the regulatory specialist in preparing for all local and Central… more
- Stanford University (Stanford, CA)
- Clinical Trials Regulatory Specialist ...Feb 16, 2024 Requisition # 100464 TheStanford Center for Clinical Research (SCCR) is a growing academic ... Our mission is to conduct and promote high-impact, innovative clinical research to improve human health. SCCR... to improve human health. SCCR seeks a mission-driven Clinical Trials Regulatory Specialist 2.… more
- Houston Methodist (Houston, TX)
- …The Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible...degree or higher **WORK EXPERIENCE** + Two years of clinical research , regulatory compliance, or… more
- Emory Healthcare/Emory University (Atlanta, GA)
- … Trials Regulatory Specialist I is an entry-level position supporting regulatory affairs in clinical trial research . + The primary focus of ... + Assists regulatory team ( Regulatory Specialist II and III) in research efforts...equivalent combination of experience, education and training. Knowledge of clinical research practices. + Must complete all… more
- Johns Hopkins University (Baltimore, MD)
- …with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies. Teaches staff about regulatory aspects. + Updates faculty on ... academic, government, or pharmaceutical industry environment. + Experience in clinical research and regulatory affairs....financial management of clinical trials. Classified Title: Clinical Research Program Specialist Job… more
- Emory Healthcare/Emory University (Decatur, GA)
- …The Regulatory Specialist II is an intermediate level position supporting regulatory affairs in clinical trial research . + Incumbents are responsible ... support an extensive and complex portfolio of trials. + Duties include: + Supports clinical research team (physicians, nurses, etc.) in research efforts by… more
- University of Maryland, Baltimore (Baltimore, MD)
- …(UMB) Marlene & Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is seeking a full-time Clinical Research Specialist within the Clinical ... within the UMGCCC Cancer Research Network.* The Clinical Research Specialist will work...a liaison to facilitate communication, resolve issues, and meet regulatory requirements. /*Up to 25% travel will be required… more
