• Feature ArticlesFeature Articles

    Good writing skills as a cornerstone for career advancement

    Strong written communication skills are invaluable, even in a profession in which writing is not a key component. Good writing can be used as a tool to impart information or convince colleagues to pursue a particular course of action. It can also be a means of demonstrating one’s creative and strategic thinking. In short, investing time in learning and refining strong writing skills is a crucial element of career advancement.   This article will provide tools and techn...
  • Feature ArticlesFeature Articles

    Soft skills training during a pandemic: Why it’s important, and how to do it

    In this article, the author discusses the importance of soft skills training during the COVID-19 pandemic in the context of their role in defining one’s employability and advancing both personal and team success in achieving goals. These training sessions will give employees an opportunity to connect virtually with their colleagues, improve morale, and provide skills that will increase productivity and create a more positive working environment. The article provides tools ...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    Updated Regulatory Writing Book Now Available

    It isn’t easy to be a highly effective regulatory writer, but clear, well-written documentation is a critical part of bringing essential medicines and medical products to market. In RAPS’ newly released, Regulatory Writing: An Overview, Second Edition , aspiring and experienced writers alike will find expert guidance and advice that is easy to apply. Completely updated from the previous edition, Regulatory Writing covers content development for regulatory documents...
  • RAPS' LatestRAPS' Latest

    RAPS Seeks Authors for Regulatory Writing Book

    • 25 February 2016
    RAPS is planning to publish a regulatory writing handbook later this year and is seeking contributing authors. Chapters will be due in late summer. If you or a colleague have expertise in any of the available topics and would be interested in sharing that knowledge, please contact Senior Editor Pam Jones at pjones@raps.org with the specific topic and a CV. Available topics are: Policies, Codes and Guidance for Industry Overview of ICH guidelines for regulator...
  • RAPS' LatestRAPS' Latest

    The Art of Saying Yes and No

    ‘Yes’ and ‘no’ are two simple words in the English language, but they generate a vast array of mind-boggling complexities when used incorrectly—whether intentionally or unintentionally. How many of us have said yes when we actually wanted to say—or should have said—no, and vice versa? Imagine you are invited to party you have no desire to attend, and inside you are screaming “no,” but you say yes because you do not want to offend the host or wish others to think y...
  • RAPS' LatestRAPS' Latest

    Chicago Workshop to Help Regulatory Pros Communicate More Effectively

    Most regulatory professionals do not have a background—or often any training at all—in communications. Yet they are called upon every day to be effective communicators. Whether it’s communicating with their peers on a regulatory team, colleagues in other areas within their organizations, upper management, regulators, researchers, contractors or others, regulatory pros need to be clear, establish credibility and influence people in different disciplines and at many d...
  • RAPS' LatestRAPS' Latest

    How to be a Regulatory Leader

    Increasingly, regulatory professionals need to be effective leaders. Not only are they leading regulatory departments and cross-functional work groups, they also are being called upon to play key roles on corporate and organizational leadership teams. RAPS’ Scope of Practice Study shows that regulatory professionals now spend up to a third of their time working on strategy or business-related duties. Recognizing the value regulatory experts bring to the C-suite, s...
  • Feature ArticlesFeature Articles

    Writing Skills for the Regulatory Professional

    Later this year, RAPS will publish a new book, Regulatory Writing, co-authored and edited by Mukesh Kumar, PhD. Kumar has been a teacher, practitioner, innovator and researcher in the healthcare regulatory and scientific professions for 18 years. This article is an introductory overview of his upcoming book. Regulatory professionals have to write highly technical documents for a variety of audiences. These documents include clinical study reports, protoco...
  • Feature ArticlesFeature Articles

    'Cafeteria-Style' Approach to Training for the Regulatory Technical Writer

    One team at Merck is implementing a flexible training methodology, referred to as the “cafeteria-style” approach to training, to provide effective, efficient instruction for onboarding regulatory technical writers. This approach provides training as needed to create an environment that facilitates writing high-quality regulatory documents. Since training is provided when needed, performing the actual job reinforces the training and helps technical writers accomplish...
  • Feature ArticlesFeature Articles

    Two Extraordinary Medical Writers: Lewis Thomas and Sherwin Nuland

    I taught a scientific writing course this summer at a local college. One of my goals was to introduce the students to exemplary writers and to suggest each student attempt to emulate their styles in composition. While there are a number of outstanding medical writers from which to choose, two are truly exceptional and in a class by themselves. Both write the kinds of sentences you like to read over and over again. I have written about them before, but their contributions ...
  • Legislation Introduced to Require 'Plain Writing' for all Regulations

    The US Food and Drug Administration (FDA) could be statutorily required to use "plain writing" in all of its future regulations if a piece of proposed legislation has its way. The proposed bill, The Plain Writing Act for Regulations of 2012 , would "require that Federal regulations use plain writing to enhance public understanding of regulations" in the hopes that such language would "increase the level of public participation in the rulemaking process." The bill, intr...