31 to 45 of 47
Lead/support equipment, process, and software validation activities using IQ, OQ, PQ methodology Coordinate validation executions according to protocol instructions/procedures Compile validation packages and assure all required documentation is accurate and complete Assure thoroughness of the investigation, documentation, and closure Plan, coordinate, and track the progre
Posted 22 days ago
Conduct onsite health and safety inspections and waste management audits Create and present safety training Prepare technical documents Provide ongoing management of existing EHS programs Assist with Injury/Illness reporting, investigations, tracking, and hazard resolution EXPERIENCE Minimum of 2 years of EHS experience required Knowledge of federal and state regulations
Posted 22 days ago
Develop copy content for outlines, design documents, electronic storyboards, presentations, assessment questions, and more Identify, describe, or create visual or interactive elements related to scientific content Conduct required research in a timely and proficient manner, utilizing the appropriate resources Create scientifically accurate, strategically aligned, grammati
Posted 23 days ago
Support and ensure the establishment of objective, measurable, discrete, and verifiable customer/product requirements Ensure products meet regulatory requirements, quality standards, and are consistent with company policies Review and approve design control and human factors documentation Assist with Risk Management activities (RMP, HA, DFMEA, PFMEA, UFMEA and RMR) and sa
Posted 23 days ago
Author and maintain study related documents (protocol synopsis, protocol, CSR, IB, etc.) Evaluate and provide medical/scientific input to safety sections of study related documents generated by other departments Develop and maintain standardized clinical study documents related to the Clinical Research department (protocol template, safety reporting standard, SOP, etc.) R
Posted 23 days ago
Design studies utilizing novel technologies to improve platform processes Create improvements to platform process for activation, transduction, and expansion unit operations Lead studies to identify and characterize individual donor attributes which impact final product CQAs Supervise the execution of CMC studies on candidate products, present data, and advise on suitabil
Posted 23 days ago
Create long /short term plans and set targets for milestones and deadlines Work with Project Managers in different functions to organize activities based on the goals of the organization Ensure different cross functional team efforts remain in synergy by acting as the central point of contact Devise new programs that support the organization's objectives Create sustainabl
Posted 23 days ago
Ensure product complaint investigations, procedures, and other activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance Maintain good laboratory practices (GLP) consistent with product development objectives/regulatory requirements and ensure all 5S activities are established/continuously maintained Review customer complaint
Posted 24 days ago
Ensure human factors and usability plans are appropriately scaled Manage the work of external vendors and consult with project teams to ensure quality deliverables Support teams in the execution of deliverables associated with closing gaps in project usability files Drive understanding of the human system interface through the creation of user profiles, environmental char
Posted 24 days ago
Ensure product complaint investigations, procedures, and other activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance Maintain good laboratory practices (GLP) consistent with product development objectives/regulatory requirements and ensure all 5S activities are established/continuously maintained Review customer complaint
Posted 24 days ago
Develop comprehensive Monitoring Plans (MP) Participate in the study start up process including site identification, qualification, selection, and initiation activities Coordinate study start up activities of the CSAs and collaborating with Global Study Start Up per study timelines Lead Clinical CSA activities through site selection, activation, maintenance, and study clo
Posted 24 days ago
Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchanges Review protocol development, clinical study reports, and statistical analysis plans, as required Provide input to CRF design and CRF Completion Instructions Develop test scripts and perform user acceptance testing/validation of the data
Posted 24 days ago
Perform copy editing for grammar, punctuation, style, and internal consistency on clinical protocols, clinical study reports (CSRs), investigator's brochures, summary document, and safety reports Collaborate effectively with other functional area authors to achieve submission schedules as prioritized by senior management Administer Quality Control checks to ensure documen
Posted 24 days ago
OVERVIEW Advanced Clinical is currently recruiting on the behalf of a Rare Disease Pharma based in Menlo Park, California and we are seeking an experienced Clinical Research Associate II (CRA II). Working for an exciting start up Pharma, who has an exceptional company culture, this role will provide excellent visibility to the Directors of Clinical Ops and C Suite leaders
Posted 26 days ago
Write failure analysis report and communicate findings with complaint handlers Interpret and communicate trends Prioritize work based on severity and occurrence of each failure mode Focus on continuous improvement of Post Market Surveillance system and cross functional interfaces with internal teams Help identify product trends and drive actionable insights Extract and fo
Posted 30 days ago
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