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Summary Report for:
11-9199.01 - Regulatory Affairs Managers

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Sample of reported job titles: Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Product Manager

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Tasks  |  Tools & Technology  |  Knowledge  |  Skills  |  Abilities  |  Work Activities  |  Detailed Work Activities  |  Work Context  |  Job Zone  |  Education  |  Credentials  |  Interests  |  Work Styles  |  Work Values  |  Related Occupations  |  Wages & Employment  |  Job Openings

Tasks

  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence. See more occupations related to this task.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. See more occupations related to this task.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. See more occupations related to this task.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. See more occupations related to this task.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. See more occupations related to this task.
  • Manage activities such as audits, regulatory agency inspections, or product recalls. See more occupations related to this task.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products. See more occupations related to this task.
  • Provide responses to regulatory agencies regarding product information or issues. See more occupations related to this task.
  • Maintain current knowledge of relevant regulations, including proposed and final rules. See more occupations related to this task.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. See more occupations related to this task.
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. See more occupations related to this task.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. See more occupations related to this task.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. See more occupations related to this task.
  • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards. See more occupations related to this task.
  • Participate in the development or implementation of clinical trial protocols. See more occupations related to this task.
  • Develop and maintain standard operating procedures or local working practices. See more occupations related to this task.
  • Establish regulatory priorities or budgets and allocate resources and workloads. See more occupations related to this task.
  • Train staff in regulatory policies or procedures. See more occupations related to this task.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. See more occupations related to this task.
  • Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats. See more occupations related to this task.
  • Contribute to the development or implementation of business unit strategic and operating plans. See more occupations related to this task.
  • Coordinate internal discoveries and depositions with legal department staff. See more occupations related to this task.
  • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations. Green Task Statement See more occupations related to this task.
  • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation. Green Task Statement See more occupations related to this task.
  • Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives. Green Task Statement See more occupations related to this task.
  • Monitor regulatory affairs trends that are related to environmental issues. Green Task Statement See more occupations related to this task.

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Tools & Technology

Tools used in this occupation:

  • Desktop computers See more occupations related to this tool.
  • Laser fax machine — Laser facsimile machines See more occupations related to this tool.
  • Laser printers — Computer laser printers See more occupations related to this tool.
  • Notebook computers — Laptop computers See more occupations related to this tool.
  • Personal computers See more occupations related to this tool.
  • Photocopiers — Photocopying equipment See more occupations related to this tool.
  • Special purpose telephones — Multi-line telephone systems See more occupations related to this tool.

Technology used in this occupation:

  • Analytical or scientific software — Analyse It; Risk management software; Statistical analysis software See more occupations related to this technology.
  • Compliance software — Aris Global Register; MediRegs Regulation and Reimbursement Suite; SAP EHS Management; Thomson Reuters Liquent InSight Suite (see all 10 examples) See more occupations related to this technology.
  • Data base user interface and query software — Database software See more occupations related to this technology.
  • Desktop publishing software — Document publishing software See more occupations related to this technology.
  • Document management software — Adlib Express; Adobe Systems Adobe Acrobat software; Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD; Virtify eCTD (see all 32 examples) See more occupations related to this technology.
  • Electronic mail software — Microsoft Outlook See more occupations related to this technology.
  • Enterprise application integration software — XML authoring software See more occupations related to this technology.
  • Information retrieval or search software — Dialog DialogLink See more occupations related to this technology.
  • Internet browser software — Web browser software See more occupations related to this technology.
  • Office suite software — Microsoft Office software See more occupations related to this technology.
  • Operating system software — Microsoft Windows See more occupations related to this technology.
  • Project management software — Microsoft Project; Total quality management TQM software See more occupations related to this technology.
  • Spreadsheet software — Microsoft Excel See more occupations related to this technology.
  • Word processing software — Microsoft Word See more occupations related to this technology.

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Knowledge

  • English Language — Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. See more occupations related to this knowledge.
  • Law and Government — Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process. See more occupations related to this knowledge.
  • Medicine and Dentistry — Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures. See more occupations related to this knowledge.
  • Administration and Management — Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources. See more occupations related to this knowledge.
  • Biology — Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment. See more occupations related to this knowledge.
  • Clerical — Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology. See more occupations related to this knowledge.
  • Education and Training — Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects. See more occupations related to this knowledge.
  • Chemistry — Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods. See more occupations related to this knowledge.
  • Computers and Electronics — Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming. See more occupations related to this knowledge.
  • Customer and Personal Service — Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction. See more occupations related to this knowledge.

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Skills

  • Reading Comprehension — Understanding written sentences and paragraphs in work related documents. See more occupations related to this skill.
  • Speaking — Talking to others to convey information effectively. See more occupations related to this skill.
  • Writing — Communicating effectively in writing as appropriate for the needs of the audience. See more occupations related to this skill.
  • Active Listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times. See more occupations related to this skill.
  • Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. See more occupations related to this skill.
  • Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one. See more occupations related to this skill.
  • Coordination — Adjusting actions in relation to others' actions. See more occupations related to this skill.
  • Monitoring — Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action. See more occupations related to this skill.
  • Time Management — Managing one's own time and the time of others. See more occupations related to this skill.
  • Systems Analysis — Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes. See more occupations related to this skill.
  • Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions. See more occupations related to this skill.
  • Instructing — Teaching others how to do something. See more occupations related to this skill.
  • Management of Personnel Resources — Motivating, developing, and directing people as they work, identifying the best people for the job. See more occupations related to this skill.
  • Negotiation — Bringing others together and trying to reconcile differences. See more occupations related to this skill.
  • Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making. See more occupations related to this skill.
  • Operations Analysis — Analyzing needs and product requirements to create a design. See more occupations related to this skill.
  • Persuasion — Persuading others to change their minds or behavior. See more occupations related to this skill.
  • Social Perceptiveness — Being aware of others' reactions and understanding why they react as they do. See more occupations related to this skill.
  • Systems Evaluation — Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system. See more occupations related to this skill.
  • Service Orientation — Actively looking for ways to help people. See more occupations related to this skill.

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Abilities

  • Written Comprehension — The ability to read and understand information and ideas presented in writing. See more occupations related to this ability.
  • Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences. See more occupations related to this ability.
  • Oral Expression — The ability to communicate information and ideas in speaking so others will understand. See more occupations related to this ability.
  • Written Expression — The ability to communicate information and ideas in writing so others will understand. See more occupations related to this ability.
  • Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense. See more occupations related to this ability.
  • Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem. See more occupations related to this ability.
  • Speech Clarity — The ability to speak clearly so others can understand you. See more occupations related to this ability.
  • Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events). See more occupations related to this ability.
  • Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations). See more occupations related to this ability.
  • Speech Recognition — The ability to identify and understand the speech of another person. See more occupations related to this ability.
  • Near Vision — The ability to see details at close range (within a few feet of the observer). See more occupations related to this ability.
  • Fluency of Ideas — The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity). See more occupations related to this ability.
  • Category Flexibility — The ability to generate or use different sets of rules for combining or grouping things in different ways. See more occupations related to this ability.
  • Originality — The ability to come up with unusual or clever ideas about a given topic or situation, or to develop creative ways to solve a problem. See more occupations related to this ability.
  • Selective Attention — The ability to concentrate on a task over a period of time without being distracted. See more occupations related to this ability.

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Work Activities

  • Evaluating Information to Determine Compliance with Standards — Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards. See more occupations related to this activity.
  • Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources. See more occupations related to this activity.
  • Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person. See more occupations related to this activity.
  • Communicating with Persons Outside Organization — Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail. See more occupations related to this activity.
  • Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job. See more occupations related to this activity.
  • Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time. See more occupations related to this activity.
  • Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work. See more occupations related to this activity.
  • Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems. See more occupations related to this activity.
  • Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form. See more occupations related to this activity.
  • Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used. See more occupations related to this activity.
  • Interacting With Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information. See more occupations related to this activity.
  • Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them. See more occupations related to this activity.
  • Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts. See more occupations related to this activity.
  • Resolving Conflicts and Negotiating with Others — Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others. See more occupations related to this activity.
  • Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events. See more occupations related to this activity.
  • Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data. See more occupations related to this activity.
  • Scheduling Work and Activities — Scheduling events, programs, and activities, as well as the work of others. See more occupations related to this activity.
  • Developing and Building Teams — Encouraging and building mutual trust, respect, and cooperation among team members. See more occupations related to this activity.
  • Coordinating the Work and Activities of Others — Getting members of a group to work together to accomplish tasks. See more occupations related to this activity.
  • Provide Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics. See more occupations related to this activity.
  • Coaching and Developing Others — Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills. See more occupations related to this activity.
  • Guiding, Directing, and Motivating Subordinates — Providing guidance and direction to subordinates, including setting performance standards and monitoring performance. See more occupations related to this activity.
  • Training and Teaching Others — Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others. See more occupations related to this activity.
  • Thinking Creatively — Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions. See more occupations related to this activity.
  • Performing Administrative Activities — Performing day-to-day administrative tasks such as maintaining information files and processing paperwork. See more occupations related to this activity.
  • Monitor Processes, Materials, or Surroundings — Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems. See more occupations related to this activity.
  • Staffing Organizational Units — Recruiting, interviewing, selecting, hiring, and promoting employees in an organization. See more occupations related to this activity.
  • Selling or Influencing Others — Convincing others to buy merchandise/goods or to otherwise change their minds or actions. See more occupations related to this activity.
  • Judging the Qualities of Things, Services, or People — Assessing the value, importance, or quality of things or people. See more occupations related to this activity.

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Detailed Work Activities

  • Review documents or materials for compliance with policies or regulations. See more occupations related to this activity.
  • Manage control system activities in organizations. See more occupations related to this activity.
  • Develop operating strategies, plans, or procedures. See more occupations related to this activity.
  • Advise others on legal or regulatory compliance matters. See more occupations related to this activity.
  • Maintain regulatory or compliance documentation. See more occupations related to this activity.
  • Monitor organizational compliance with regulations. See more occupations related to this activity.
  • Confer with organizational members to accomplish work activities. See more occupations related to this activity.
  • Monitor external affairs or events affecting business operations. See more occupations related to this activity.
  • Develop organizational goals or objectives. See more occupations related to this activity.
  • Monitor organizational procedures to ensure proper functioning. See more occupations related to this activity.
  • Implement organizational process or policy changes. See more occupations related to this activity.
  • Communicate organizational policies and procedures. See more occupations related to this activity.
  • Develop organizational policies or programs. See more occupations related to this activity.
  • Prepare staff schedules or work assignments. See more occupations related to this activity.
  • Examine marketing materials to ensure compliance with policies or regulations. See more occupations related to this activity.
  • Prepare operational budgets. See more occupations related to this activity.
  • Conduct employee training programs. See more occupations related to this activity.
  • Establish interpersonal business relationships to facilitate work activities. See more occupations related to this activity.
  • Maintain knowledge of current developments in area of expertise. See more occupations related to this activity.
  • Prepare reports related to compliance matters. See more occupations related to this activity.
  • Coordinate with external parties to exchange information. See more occupations related to this activity.
  • Develop organizational methods or procedures. See more occupations related to this activity.
  • Coordinate operational activities with external stakeholders. See more occupations related to this activity.
  • Represent the organization in external relations. See more occupations related to this activity.
  • Evaluate potential of products, technologies, or resources. See more occupations related to this activity.
  • Evaluate environmental impact of operational or development activities. See more occupations related to this activity.

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Work Context

  • Electronic Mail — 100% responded “Every day.” See more occupations related to this work context.
  • Telephone — 88% responded “Every day.” See more occupations related to this work context.
  • Work With Work Group or Team — 70% responded “Extremely important.” See more occupations related to this work context.
  • Duration of Typical Work Week — 84% responded “More than 40 hours.” See more occupations related to this work context.
  • Face-to-Face Discussions — 75% responded “Every day.” See more occupations related to this work context.
  • Spend Time Sitting — 75% responded “Continually or almost continually.” See more occupations related to this work context.
  • Contact With Others — 58% responded “Constant contact with others.” See more occupations related to this work context.
  • Importance of Being Exact or Accurate — 58% responded “Extremely important.” See more occupations related to this work context.
  • Letters and Memos — 52% responded “Every day.” See more occupations related to this work context.
  • Indoors, Environmentally Controlled — 79% responded “Every day.” See more occupations related to this work context.
  • Structured versus Unstructured Work — 58% responded “Some freedom.” See more occupations related to this work context.
  • Freedom to Make Decisions — 52% responded “Some freedom.” See more occupations related to this work context.
  • Impact of Decisions on Co-workers or Company Results — 48% responded “Important results.” See more occupations related to this work context.
  • Time Pressure — 33% responded “Every day.” See more occupations related to this work context.
  • Coordinate or Lead Others — 58% responded “Very important.” See more occupations related to this work context.
  • Responsibility for Outcomes and Results — 45% responded “High responsibility.” See more occupations related to this work context.
  • Frequency of Decision Making — 30% responded “Every day.” See more occupations related to this work context.
  • Deal With External Customers — 36% responded “Important.” See more occupations related to this work context.
  • Frequency of Conflict Situations — 36% responded “Once a week or more but not every day.” See more occupations related to this work context.
  • Consequence of Error — 25% responded “Extremely serious.” See more occupations related to this work context.
  • Importance of Repeating Same Tasks — 39% responded “Very important.” See more occupations related to this work context.
  • Level of Competition — 45% responded “Moderately competitive.” See more occupations related to this work context.

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Job Zone

Title Job Zone Four: Considerable Preparation Needed
Education Most of these occupations require a four-year bachelor's degree, but some do not.
Related Experience A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.
Job Training Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
Job Zone Examples Many of these occupations involve coordinating, supervising, managing, or training others. Examples include accountants, sales managers, database administrators, teachers, chemists, art directors, and cost estimators.
SVP Range (7.0 to < 8.0)

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Education


Percentage of Respondents
Education Level Required
64   Bachelor's degree
21   Master's degree
6   Post-baccalaureate certificate Help

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Credentials

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Interests

Interest code: EC

  • Enterprising — Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business. See more occupations related to this interest.
  • Conventional — Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow. See more occupations related to this interest.

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Work Styles

  • Integrity — Job requires being honest and ethical. See more occupations related to this work style.
  • Attention to Detail — Job requires being careful about detail and thorough in completing work tasks. See more occupations related to this work style.
  • Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations. See more occupations related to this work style.
  • Initiative — Job requires a willingness to take on responsibilities and challenges. See more occupations related to this work style.
  • Leadership — Job requires a willingness to lead, take charge, and offer opinions and direction. See more occupations related to this work style.
  • Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high stress situations. See more occupations related to this work style.
  • Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace. See more occupations related to this work style.
  • Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems. See more occupations related to this work style.
  • Cooperation — Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude. See more occupations related to this work style.
  • Achievement/Effort — Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks. See more occupations related to this work style.
  • Persistence — Job requires persistence in the face of obstacles. See more occupations related to this work style.
  • Self Control — Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations. See more occupations related to this work style.
  • Independence — Job requires developing one's own ways of doing things, guiding oneself with little or no supervision, and depending on oneself to get things done. See more occupations related to this work style.
  • Innovation — Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems. See more occupations related to this work style.
  • Social Orientation — Job requires preferring to work with others rather than alone, and being personally connected with others on the job. See more occupations related to this work style.

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Work Values

  • Achievement — Occupations that satisfy this work value are results oriented and allow employees to use their strongest abilities, giving them a feeling of accomplishment. Corresponding needs are Ability Utilization and Achievement. See more occupations related to this work value.
  • Independence — Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy. See more occupations related to this work value.
  • Support — Occupations that satisfy this work value offer supportive management that stands behind employees. Corresponding needs are Company Policies, Supervision: Human Relations and Supervision: Technical. See more occupations related to this work value.

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Related Occupations

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Wages & Employment Trends

Median wages data collected from Managers, All Other.
Employment data collected from Managers, All Other.
Industry data collected from Managers, All Other.

Median wages (2014) $50.51 hourly, $105,060 annual
State wages Local Salary Info
 
Employment (2012) 898,000 employees
Projected growth (2012-2022) Slower than average (3% to 7%) Slower than average (3% to 7%)
Projected job openings (2012-2022) 249,100
State trends Employment Trends
 
Top industries (2012)

Source: Bureau of Labor Statistics 2014 wage data external site and 2012-2022 employment projections external site. "Projected growth" represents the estimated change in total employment over the projections period (2012-2022). "Projected job openings" represent openings due to growth and replacement.

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Job Openings on the Web

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