The Senior Technical Information Specialist provides support for the Food and Drug Administration (FDA), onsite Records Information Management (RIM) office. This position provides information by designing methods to collect and retrieve data.
Scientific computing and federally mandated records keeping requirements have made it necessary for the FDA to move from a paper centric agency to a media neutral information-based organization. RIM will provide direct support to the FDA’s move to a broader information-based organization by supporting core functions related to the processing of records material that support scientific advancement, public health issues and the regulatory review process.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Essential duties and responsibilities include the following. Other duties may be assigned.
Responsible for the integration of CNI Core Competencies into daily functions, including: commitment to integrity, knowledge / quality of work, supporting financial goals of the company, initiative / motivation, cooperation / relationships, problem analysis / discretion, accomplishing goals through organization, positive oral / written communication skills, leadership abilities, commitment to Affirmative Action, reliability / dependability, flexibility and ownership / accountability of actions taken.
Demonstrates proficiency in reading, analyzing, classifying and interpreting regulatory submissions.
Implements standard operating procedures (SOPs) and trains staff in their use.
Possesses experience with scientific regulatory documents, and demonstrated speaking, writing, and customer service skills.
Exercises experience in areas such as quality control, inventorying records, scanning, micrographics and overseeing document tracking databases.
Leads special project teams.
Responsible for aiding in own self-development by being available and receptive to any training made available by the company.
Plans daily activities within the guidelines of company policy, job description and supervisor’s instruction in such a way as to maximize personal output.
Responsible for keeping own immediate work area in a neat and orderly condition to ensure safety of self and coworkers. Will report any unsafe conditions and/or practices to the appropriate supervisor and human resources. Will immediately correct any unsafe conditions to the best of own ability.
Bachelor’s degree in Science or Information Management. Minimum of three (3) years’ of increasingly responsible experience in records and document management required. Ability to lead special project teams is preferred.
CERTIFICATES / LICENSES / REGISTRATION
JOB SPECIFIC KNOWLEDGE / SKILLS / ABILITIES
Demonstrated competency in working with a wide range of government departments with diverse business needs, interests, expectations and requirements
Skilled proficiency using Microsoft Office Suite (i.e., Word, Excel, Outlook, etc.)
Thorough knowledge of technical writing techniques / practices with understanding of key business processes
Demonstrated knowledge of design and maintenance software development related to product documentation and communication
Ability to communicate and translate communication and documentation needs to business and technical teams
Exceptional skills in researching, writing, reviewing and editing technical documents and other materials
Excellent verbal and written communication skills with ability to use correct grammar, spelling and usage of the English language
Excellent customer service and relationship-building skills with ability to work well with others for the successful achievement of goals
Detail-oriented with ability to plan, organize, coordinate and execute work
Ability to meet deadlines and work under pressure in situations where diverse demands are involved
Ability to work both individually and in a team environment
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job. Work is primarily performed in an office environment. Regularly required to sit. Regularly required use hands to finger, handle, or feel, reach with hands and arms to handle objects and operate tools, computer, and/or controls. Must be able to talk and hear. Occasionally required to stand, walk and stoop, kneel, crouch, or crawl. Must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. May be required to lift, push or pull 50 pounds or more using cart or hand truck. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus. May work near moving or mechanical parts. May have exposure to chemicals, fumes, warehouse environment or adverse weather conditions. May be required to use safety and personal protective equipment.
Complex Problem Solving