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Build and maintain a good business relationship with cross functional departments including Manufacturing, QC, PD, and IT, providing quality service and quality oversight on GMP manufacturing area Oversee clinical GMP manufacturing, and support with batch disposition Provide thorough review of product release packages including executed batch records, CoAs, associated OOS
Posted Today
Build and maintain a good business relationship with cross functional departments and provide quality service/oversight on GMP manufacturing area Issue Forms, Logbooks, Notebooks, and any documentation required for manufacturing operations, QC lab, and other departments Offer support with batch record issuance, all corresponding documentation to the manufacturing area in
Posted Today
Participate in cross functional teams to develop and implement Clinical Study protocols within clinical programs Collaborate with internal teams, CROs, and external vendors to prepare, review, and finalize clinical protocol documents Contribute to scientific and operational aspects and stages of the protocol development and execution from study design planning through fin
Posted Today
Maintain all qualified equipment systems in compliance with policies, guidelines, and procedures Contribute to change controls, validation plans, qualification protocols, associated reports, and procedures Author, review, and/or execute qualification/validation protocols Execute qualification and/or validation of equipment, process control systems validation (CSV), cleani
Posted Today
Provide medical writing support for multiple compounds and multiple projects within assigned therapeutic area(s) Collaborate with multiple functional area teams that support various investigational compounds' clinical development with preparing clinical study protocols Edit multiple investigational compounds' safety and efficacy summary documents and other documents that
Posted 2 days ago
Work within the R&D team to perform high resolution genomic profiling of bulk and single cells in cellular reprogramming experiments Manage Nucleic acid extraction and library preparation for next generation sequencing analysis of epigenetic and transcriptomic signatures Design and implement epigenetic reprogramming experiments utilizing transcription factors and epigenet
Posted 2 days ago
Support the development of therapeutics platform for precise and controlled epigenetic programming of cellular states to address aging and aging related diseases Work within the R&D team to design and analyze high dimensional genomic datasets derived from epigenetic reprogramming experiments Curate and combine external and internal genomics datasets Develop machine learni
Posted 2 days ago
Perform cGMP QC Microbiology testing including Mycoplasma testing, Gram Staining, Microorganism Culture/Isolation, Growth Promotion/Sterility testing, plate incubation/reading, CFU counting and Endotoxin Testing Support for manufacturing in Environmental Monitoring and gowning qualifications Conduct trending and statistical analysis of Environmental Monitoring and testing
Posted 6 days ago
Develop project plans and corresponding project management tools to support the execution of all projects Manage cross functional teams (including 3rd party resources) Execute Human Factors Engineering & Usability activities Write protocols, reports, specifications, procedures, technical assessments, etc. Ensure the proper conduct of studies with regulations and SOPs Esta
Posted 8 days ago
Lead clinical study design and collaborate internally to construct high quality clinical study protocols Engage and introduce new compounds in development to external scientific leaders/KOLs and seek feedback for clinical development plan and protocols Plan/execute site assessment, site selection, and train investigators/staff Perform clinical monitor for studies and work
Posted 8 days ago
Contribute to the achievement of established department goals/objectives and adhere to department policies, procedures, quality standards, and safety standards Demonstrate support for compliance in the performance of job duties and responsibilities Perform skills and duties that are within the scope of nursing practice Facilitate feasibility assessment, site qualification
Posted 9 days ago
Process an average of 25 30 contracts Review and move contracts through the process from legal review to final signatures Ensure contracts are routed to the correct people and all steps/tasks are completed EXPERIENCE Minimum of 5 years of experience with general contracting required Clinical experience required Strong G&A experience (Facilities, TechOps, HR, etc.) Experie
Posted 11 days ago
Manage study timelines, quality of deliverables from vendors, and approved trial budget(s) throughout the life of the assigned clinical trial(s) Participate in the selection of study vendors, including obtaining cross functional agreement of vendor scope Negotiate vendor budgets and business terms of Work Orders Monitor CRO/vendor performance and provide clear scope, expe
Posted 12 days ago
Record, assess, and reconcile Product Quality Complaints Coordinate collection of additional information from external and internal stakeholders Provide prompt support and guidance to patient's inquiries and facilitate cross functional activities to resolve issues related to complaints Collaborate with the Contract Manufactures to ensure on time closures Collect, prepare
Posted 12 days ago
Advanced Clinical
- Menlo Park, CA
Provide meeting scheduling and logistics including call/web conference activation and resolution of technical issues Distribute agendas and generate meeting minutes Deliver study file maintenance for electronic and hard copy Manage document tracking and signature/approval follow up including Confidential Disclosure Agreements, contracts, proposals, payments, invoices, and
Posted 12 days ago
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