Technical Writer IV
The Technical Writer IV leads the development and maintenance of documentation for the Food and Drug Administration (FDA), Office of Regulatory Science (ORS), Office of Regulatory Affairs (ORA) testing labs. This position works with Associate Directors to develop the following plans; Concept of Operation Plan, Communication Management Plan, and Strategic Plan, to guide ORS in establishing a national laboratory and science network.
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.
Understands the entire project context, and demonstrates the knowledge of design development, maintenance development and product related documentation and communication.
Reviews content of technical documentation, ensures that documents are clear and follow simple language in compliance with FDA plain language guidelines.
Possesses and applies a comprehensive knowledge of one or more technical writing and editing methodologies.
Analyzes and develops solutions to highly complex documentation and communication problems and offers writing and editing solutions at an advanced level.
Interacts with development teams to develop a strong understanding of the project and documentation objectives.
Responsible for aiding in own self-development by being available and receptive to all 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.
EDUCATION / EXPERIENCE
Bachelor’s degree and related Project Management experience in IT, operations and/or management and a minimum two (2) years’ experience of general history governmental writing experience; or an equivalent combination of education/experience.
Experience in science and project management (PM) preferred.
CERTIFICATES / LICENSES / REGISTRATION
JOB SPECIFIC KNOWLEDGE / SKILLS / ABILITIES
Mastery of the English language, grammar, punctuation, and spelling.
In depth knowledge of written and graphic communication presentations, and specific governmental regulations governing documentation preparation.
Proficient knowledge and understanding of developing project documents
Operational knowledge of the federal government work environment
Expert proficiency in document development (i.e., software specifications, user guides, training materials etc.)
Superior technical writing and editing skills with comprehensive knowledge of accepted practices and methodologies
Thorough knowledge and understanding of key business processes with ability to communicate / translate needs to others
Exceptional verbal and written communication skills
Highly organized and extremely detail-oriented with ability to quickly grasp business needs and issues
Self-motivated with demonstrated ability to manage workload and time effectively
Ability to work both independently and in a team environment
Flexible with ability to interact and work well with others for the successful achievement of goals
Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.