in life sciences, health informatics, computer science, or related field. Advanced degree preferred. Strong understanding...
management, particularly in the oncology field. Requirements: Bachelor's degree in Life Sciences, Computer Science...
management, particularly in the oncology field. Requirements: Bachelor's degree in Life Sciences, Computer Science...
Regulatory Compliance (FDA, ISO 13485, 21 CFR Part 820). Requirements: 4-6 years in a regulated medical device or life... sciences manufacturing environment. Strong background in Supplier Quality Engineering. Hands-on production line experience...
most important research questions across clinical development, market access, and commercial use cases for our life sciences partners... (e.g., PhD, ScD, DrPH) in Biostatistics/Statistics, Data Science, Bioinformatics, Biological Sciences, Public Health, Math...
in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database...
and Adam. Proven experience with Unix and Windows operating systems. Understanding of the software development life cycle...
software development life cycle. Understanding of FDA guidelines. Good organization, time management, and attention to detail...
standards (e.g., ICH-GCP, CDISC). Requirements: Bachelor's degree in a life science, health science, pharmacy, public health...
software development life cycle. Understanding of FDA guidelines. Good organization, time management and attention to detail...
and ADaM. Proven experience with Unix and Windows operating systems. Understanding of the software development life cycle...
in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database...
). Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design...
in life science, health science, pharmacy, public health, or related field. Strong attention to detail, organizational...
Job Description: The Quality Engineer I plays a key role in maintaining product quality, compliance, and process control for medical device manufacturing. This position ensures adherence to regulatory standards, drives continuous improveme...
Roles & Responsibilities: Medical device experience, value engineering, verification, validation documentation. Project management. Experience in VAVE methodologies and tools. Knowledge of medical device development lifecycle and standa...
Roles & Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws, regulations and procedures and guidelines, the duties and responsibilities for this position are. Must be able to pe...
Job Description: We are seeking a highly motivated and detail-oriented Quality Control Engineer to join our team in Irvine, California. The ideal candidate will support Quality Assurance (QA), Supplier Quality Engineering (SQE), and Qualit...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio...
Roles & Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws, regulations and procedures and guidelines, the duties and responsibilities for this position are: Lead and drive exe...