labor_category_descriptions.pdf

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Assessment of Tobacco Constituent Pharmacology and Behavior in Nonclinical Models.
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FDA-SOL-1115032
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LAbor Category Desciptions.

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Attachment 3 Labor Category Descriptions

1. Senior Scientist: Supervises and works alongside research staff in their daily operations and research in diverse biological areas. Familiar with a variety of the field's concepts, practices, and procedures. Has a publication or proven analysis track record to result in peer acceptance as an expert. Relies on extensive experience and judgment to plan and accomplish goals. Plans, conducts, and supervises projects of major significance, necessitating advanced knowledge and the ability to originate and apply new and unique methods and procedures. Provides research leadership and supplies technical advice and counsel to other professionals and employees.

Estimates and schedules work to meet completion dates and makes adjustments as needed to meet project and budgetary goals. Provides senior technical review of major project reports and deliverables. Requires a Ph.D. or M.D. and extensive experience in their field of specialty.

2. Project Director: Responsible for the coordination and completion of projects. Oversees all aspects of projects. Sets deadlines, assigns responsibilities, and monitors and summarizes progress of project. Prepares reports for upper management regarding status of project. Familiar with a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Estimates and schedules work to meet completion dates and makes adjustments as needed to meet project and budgetary goals. Requires a Bachelor's degree.

3. Project Manager: Responsible for the coordination and completion of projects. Oversees all aspects of projects. Sets deadlines, assigns responsibilities, and monitors and summarizes progress of project. Prepares reports for upper management regarding status of project. Relies on extensive experience and judgment to plan and accomplish goals. Familiar with a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Requires a Bachelor's degree.

4. Laboratory Technician/Assistant: Performs research activities and other tasks as necessary in a laboratory environment. Records observations and measurements and reports results. Responsible for cleaning, disinfecting, and maintaining cleanrooms and equipment. Assists with receipt and inspection of raw materials, and ordering and stocking of materials and equipment. Require a bachelor's degree.

5. Research Assistant: Works under supervision of scientists to perform research activities and other tasks in a research environment. Gathers and collates basic data and performs routine analyses. Conducts literature searches and organizes data. A bachelor’s degree is required.

6. Data Manager: Reviews reports, spreadsheets and tables to check and validate facts and data.

Requires a Bachelor’s degree.

7. Statistician: Analyzes and interprets data from various sources. Compiles reports, charts, and tables based on established statistical methods. Familiar with a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Requires a Master’s degree in statistics or related field.

8. Subject Matter Expert: Recognized expertise in a highly specialized field such as pharmacology, neuroscience, behavioral pharmacology or related field. Characterized by progressive experience in their area of expertise over the last 3 years. Has a publication or proven analysis track record to result in peer acceptance as an expert in their field/discipline within the last 5 years. Provides high level expertise. Participates in all phases of studies and analyses and can apply high level research principles, methods, and data interpretation. Requires a Ph.D. or M.D.

9. Science Writer/Editor: Experience writing and editing formal scientific documents, including peer-reviewed publications, scientific chapters or books, and/or scientific government reports.

Requires a Bachelor’s degree in English or related discipline.

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