North American Science Associates Work Values

Daily Duties at North American Science Associates:

Responsible for the overall execution of preclinical studies to support the development of products to satisfy regulatory as well business requirements. As a medical research manager (study director) I am the preclinical specialist who is the single point of control and has the overall responsibility for the technical conduct of the study, including regulatory compliance as well as interpretation, analysis, documentation and reporting of study results. Responsible for the study planning, generating study protocols, coordinating and monitoring preclinical activities. Ensures the integrity of the data collected is in alignment with the study objectives. Evaluates and analyzes preclinical data and generates study reports. Documents any deviations or nonconformances and provides scientific justification in the report. Provides technical writing assistance to other study directors. Adheres to stringent timelines and ensures desired endpoints are met. Communicates with internal as well as external customers. Provides status updates to upper management as required. Provides regulatory support to clients in preparation of regulatory submissions. Mentors and trains new staff members.

What they like about North American Science Associates:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

Clinical Research, Medical Device Testing, Budget Control, Technical Writing, Study Protocol, Reporting Pre-clinical Testing, Consulting, GLP Regulations, CRO, Team Leadership / Motivation, Process Improvement, Laboratory Science, Chemistry, Training / Development, Hematology, Transfusion Medicine, Coagulation, Molecular Diagnostics, Genetics, Pre-Clinical Studies, Client Relations, Project Management, ISO 10993, Medical Technology, FDA, Study Planning / Design, MHLW, 21 CFR Part 58, EU, Data Management, GCP, IGH, IACUC, Regulatory Compliance, Data Reporting / Interpretation, GMP, Amendments, Chromosome Analysis

Skills

Microsoft Office, Project Management, Organized, Multi-tasker

These are some of the questions we asked our climbers about their experiences with North American Science Associates: