Technical writing is defined as simplifying the complex. Implied in this deceptively simple definition is an entire range of skills and characteristics that touch upon a broad range of human performance characteristics and needs. 

What do technical writers in the life sciences write? They write standard operating procedures, work instructions, job aids, batch records, reports, journal papers, manuals, user directions, label information, etc. It is not the role of technical writing to entertain or to showcase the educational level and importance of the writer. In the technical writing realm, writing simply for anyone to understand is the demonstration of excellence and superior writing skill.

 An effective technical writer must consider many aspects of the craft to be truly effective. Writers, must adopt and apply the form and style of the industry in which they work as there are differences, for example, between the documents written for a pharmaceutical production operation versus the creation of scientific journal articles. Writers must understand their audience in terms of their needs and abilities and the level of explanation that they require as well as their command of the language in which the material is written. They must have a complete and unwavering dedication to accuracy and consistency. Technical writers must understand and be skilled at collaboration as that is how accuracy is achieved – by harvesting information from subject matter experts.

Why Should You Attend

Even with the advent of technology, we still communicate with the written word. Technical writing is about conveying information quickly, accurately, clearly, and succinctly. How we communicate, how we are understood, and how the message is received directly depends upon our skills as technical writers. In the life sciences, this skill is exceedingly important. 

In the life sciences, the stakes are high in terms of the writing’s ability to enable 100% accurate understanding of the content and where applicable, performance of the task or procedure documented. In the life sciences, that could mean the difference between life or death, safety or injury, loss or recovery, contamination or purity, success or failure.

Unfortunately, technical writing is not a skill that is given much emphasis in college curriculums if any. Technical writing is a skill life sciences workers are assumed to have and are expected to demonstrate at a level of skill usually beyond the capability of most. Unfortunately, most readers of technical writing are in the “same boat.” They “don’t know a good one when they see one.”  At the end of the day, in most cases, you have mediocre writing at best that may or may not convey the message intended.

Each critical aspect of writing technical documents for the life sciences will be addressed with the goal of helping you become a better technical writer. The tips and skills presented can be applied immediately and will be evident in the very first document that you write after this virtual seminar.


This seminar will address the following:

Technical Writing Overview

  • What is technical writing
  • What role does technical writing play in the life sciences?
  • Essential elements of technical report sections
  • Learn strategies for organizing, writing, editing, and proofing documents & correspondences.

Technical Writing Basic rules and skills required for technical writers.

  • How to begin the process
  • How to collect information and determine what information is required
  • Formats, consistency and styles
  • Non-native audience considerations
  • Grammar, spelling, punctuation, numbers and symbols
  • Simplify your writing
  • Ensuring accuracy
  • Active and passive voice
  • Misconceptions and ambiguities
  • Antecedents

Knowing the Audience

  • Analyzing the audience
  • Analyzing the information – working with Subject Matter Experts
  • Know how to review and revise documents.
  • How to address comments from reviewers
  • How to negotiate with reviewers when disagreements arise between reviewers
  • Assessing and writing to the audience to produce effective written correspondence.
  • Effective techniques for extracting information from SMEs

Regulatory Requirements

  • FDA expectations for quality of written text in submitted documents.
  • Common opportunities that are often overlooked or under-estimated by aspiring writers.
  • Technical writers in the life sciences – what do they write – types of medium.
  • Mandates for documentation set forth by regulators, such as the FDA, the International Organization for Standardization (ISO), and other governing bodies.
  • How to write effective summaries and respond to FDA requests for information.

Final Document – Editing basics

  • How to incorporate comments into the final document
  • How to obtain comments in order to address timelines
  • Final approval of the document
  • Critical aspect of writing technical documents for the life sciences will be

Module 6 Summary

  • Writing submissions – structure and techniques
  • Writing investigations 

Learning Objectives

At the completion of this seminar, you will be able to:

  • Execute the technical writing process to effectively create your document.
  • Explain the results and impact of poor technical writing.
  • Execute an effective writing process.
  • Apply the principles of effective technical writing.

Who Will Benefit

Anyone in the life sciences that is tasked with writing technical material to include standard operating procedures and work instructions.

Job Functions – engineering, research & development, compliance and regulatory, operations, analytical, logistics/supply chain, training & development and technical services.

Job Titles – associates, supervisors, managers, associate directors, directors

Course Background

This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must be analyzed to determine the level of writing that must be employed to complete the document.

 Gathering the information to be included in the technical document requires collaboration between the writer and the various subject matter experts that possess the knowledge to be harvested. How that information is gathered can be an effective efficient process or an ineffective time-consuming endeavor all dependent upon the techniques employed to execute the activity. We will address the most effective techniques for extracting information from SMEs as well as those techniques that work best when observing procedures and activities to be documented.

We will end this seminar with the mechanics of technical writing ranging from planning and organizing the content through grammar, spelling and punctuation ending with writing simplification.

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Faculty Charles H. Paul

Know Your Faculty

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex regulatory, training and documentation issues.


RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria