- Alaka'ina Foundation Family of Companies (Frederick, MD)
- Regulatory , Clinical , and Technical Clinical Trial support Location MD - Frederick Job Code 10393 # of openings 1 Apply Now ... has a potential need for top talent to provide Regulatory , Clinical , and Technical Clinical Trial support services to a DoD biomedical research program… more
- University of Washington (Seattle, WA)
- …with laboratory clients (physician and other medical providers) related to aspects of technical clinical development and regulatory questions or concerns. + ... Regulatory Development (Research Scientist/Engineer-Senior (ES 10)) will supervise technical development of clinical assays and optimization of… more
- University of Washington (Seattle, WA)
- …natural beauty. **UW Medicine has an outstanding opportunity for a Director of Clinical Regulatory Affairs and Associate General Counsel to join their team.** ... **GENERAL DESCRIPTION AND PURPOSE** The Director of Clinical Regulatory Affairs (Director), Associate General Counsel...The Director participates in the management of UW Medicine regulatory compliance efforts and provides technical advice… more
- Dignity Health (Phoenix, AZ)
- …relevant communications to the physician-investigators and clinical research teams. Provides regulatory and technical guidance to the clinical program ... campus._ **Responsibilities** Manages the daily operation and supervision of the Clinical Research Regulatory Affairs area and program specialist(s) in… more
- Children's Hospital Boston (Boston, MA)
- 74351BRJob Posting Title:Safety & Quality Coordinator (Patient Safety/ Clinical Regulatory )Department:Program for Patient Safety and ... and Quality Coordinator - Patient Safety will support safety and regulatory system improvement projects and the safety event reporting system. They… more
- Sutter Health (Davis, CA)
- …transfusion / blood bank as wel as other areas of the laboratory. Functions as the technical and clinical subject matter expert in one or more areas of the ... regulatory agency inspections. Advises on, and provides guidance for, technical and clinical problem-solving or trouble-shooting, ensuring accurate and… more
- Trinity Health (Maywood, IL)
- …happening at Loyola Medicine. New state of the art Regional Clinical Laboratory. The new lab enables greater operational efficiencies, improved turnaround ... HLA **Hours:** **Day shift: Monday-Friday** **8:00am -4:30pm** Brand NEW Clinical Laboratory - Features daylight access, in an open...lab space **About the Job** In this role, the Technical Specialist (HLA) will oversee the daily operation of… more
- Pfizer (Cambridge, MA)
- …strategies with global strategies + May provide indication-specific input for efficient clinical trial development and response to regulatory authorities + May ... events, including serious adverse events, and other safety **RESPONSIBILITIES** + Provides clinical expertise and technical excellence for asset development, … more
- Lilly (Indianapolis, IN)
- …Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical guidelines concerning drug development ... study initiation and conduct (ie, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and… more
- University of Colorado (Aurora, CO)
- …phone contacts and personal interviews. + Schedule subject participation in research clinical trial. + Adhere to research regulatory standards. + Maintain ... of the Food and Drug Administration (FDA), study protocols, department, hospital/ clinical standard operating procedures, and other regulatory guidelines. +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and regulatory aspects of the products to provide medical, clinical and scientific support, mentoring and leadership across these areas. **RESPONSIBILITIES AND ... with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally to support regulatory submissions,… more
- University of Colorado (Aurora, CO)
- …- Requisition: #** **33067** **Job Summary:** **Key Responsibilities:** + Performs clinical research coordination and regulatory processes, procedures as defined ... #00821011 - Requisition: #33067** **Job Summary:** **Key Responsibilities:** + Performs clinical research coordination and regulatory processes, procedures as… more
- Johns Hopkins University (Baltimore, MD)
- …Requires minimum of two years of management experience. + Requires experience in clinical research and regulatory affairs. + Experience in protocol and informed ... and/or clinical trials. + Requires experience in clinical research and regulatory affairs including FDA...clinical trials preferred. + Proficiency in writing SOPs, technical and programmatic reports. + Proficiency in the use… more
- Pfizer (Andover, MA)
- …a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. Your initial focus ... be responsible for the execution of microbial upstream and downstream processes. As part of technical operations, you will be a team member who is relied to have a… more
- Edwards Lifesciences (Columbus, OH)
- …safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. * Develop and deliver technical training on GCPs, protocols, ... related field or equivalent + 5 years of medical device/sponsor/CRO/Pharma clinical field monitoring experience, quality assurance/control and regulatory … more
- University of Colorado (Aurora, CO)
- …of the Food and Drug Administration (FDA), study protocols, department, hospital/ clinical standard operating procedures and other regulatory guidelines + ... Clinical Sciences Professional (Open Rank)- Pediatric Endocrinology Research...grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award… more
- Astellas Pharma (Northbrook, IL)
- …for decisions and advice in scientific, clinical and/or technical areas that can impact development timelines/ regulatory review periods/acceptance ... including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions. + Responsible for design… more
- University of Colorado (Denver, CO)
- …phone contacts and personal interviews. + Schedule subject participation in research clinical trial. + Adhere to research regulatory standards. + Maintain ... of the Food and Drug Administration (FDA), study protocols, department, hospital/ clinical standard operating procedures, and other regulatory guidelines. +… more
- J&J Family of Companies (Spring House, PA)
- Associate Director, Clinical Pharmacology and Pharmacometrics - 2306103445W **Description** Janssen Research & Development, LLC is recruiting for an Associate ... Director, Clinical Pharmacology and Pharmacometrics (CPP) to be located in...goal to represent CPP and influence the scientific and regulatory environment. + Conducting hands-on pharmacokinetic and pharmacokinetic-pharmacodynamic analysis… more
- General Dynamics Information Technology (Fort Detrick, MD)
- …oversight, and consultation for regulatory , clinical , non- clinical , manufacturing, data management, biostatistics, product technical , safety monitoring. ... The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to… more