AMWA Journal

European Union Regulation on Personal Data Protection in Medical Writing

2024-02-23T10:53:52-08:00

The European General Data Protection Regulation 2016/679 (GDPR) aims to harmonize data protection laws across European Union (EU) Member States. The goal of GDPR is to ensure respect of the fundamental right to protection of the personal data and privacy, to enhance security measures, including information technology (IT) for data protection, and to render natural persons control over their personal data. Importantly, companies, institutions, freelancers (including medical writers) located outside the EU and handling personal data of natural persons living on the territory of the EU must comply with GDPR.

Medical writers edit documents related to the activities in health sector that comprise personal data, specifically health data considered as sensitive data. Therefore, medical writing should put in place robust security measures and comply with the GDPR. This article is a clarification of the GDPR notions, principles, technical and organizational measures applied to the medical writing to guarantee protection of the personal data and respect of individual’s rights and freedoms.

Questions and Answers From Freelance Pros

2024-05-20T10:08:16-07:00

What advice would you give to freelance medical writers, editors, or communicators who are new to medical writing and have limited writing experience? What are the top software tools for new medical writers? What is the role of generative artificial intelligence in medical writing?

In this issue, our Freelance Focus contributors are:

Melissa L. Bogen

Lori De Milto

Cathryn D. Evans

Alex Howson

Upcoming Events for Medical Communicators

2024-08-02T10:24:35-07:00

Advantages and Applicability of a Master Class Series as a Training Model for Mid-Career Medical Writers: Our Experience From the Perspectives of the Manager, Trainer, and Participants

2024-06-27T12:10:15-07:00

Advancement of mid-career medical writers (MWs) to senior levels requires augmentation beyond the traditional training provided to MWs at all levels. In response to this need, online training and classes taught by more experienced writers in house, external lecturers, or a mixture of both delivered through didactic presentations should be supplemented with methods that allow for interaction between the trainer and trainees and for a tailored approach.

We therefore designed an interactive, engaging, and dynamic training model that would draw on varied perspectives of colleagues. This Master Class Series was led by an external instructor and was based on a structured critique of regulatory document organization, content, and style. In this article, we share our experience from the perspectives of manager, trainer, and participant.

The Master Class Series was successful in part because of its dynamic content. The participants felt that this training greatly improved their understanding of the broader contexts in which documents are used and their ability to develop coherent documents. Participants further felt that their ability to implement a top-down approach in strategy documents and in applying lean writing principles was enhanced. They all agreed that they greatly benefit from exposure to each other’s creativity in solving challenges in data and content presentation and concurred that it is very likely that they would sign up for a course with a similar model in the future. Our experience indicates that a Master Class Series is essential to the training of mid-career MWs.

The Call of the Open Road: Is Medical Writing Right for You?

2024-07-02T09:49:10-07:00

The questions I’m asked about medical writing are often “how do I become a medical writer?” or “what is the best background?” or “what kind of training is crucial to success?” I’d like to humbly suggest that these are the wrong questions. I think a better question might be, “how do I know I’ll be happy as a medical writer?”

Training the Medical Writers of the Future Using a Structured Entry-Level Program: A Life Sciences Communications Agency Perspective

2024-06-12T13:51:01-07:00

Ensuring that associate medical writers are set up for success requires a well-planned entry-level program that integrates training sessions with on-the-job experience. We describe how we have crafted our program for entrylevel candidates starting from our interview process and moving to our training program, how we embed them into teams and provide on the-job training, how our support network is structured, and how we measure success. Feedback from recent participants in our training program offers valuable hands-on insights. A robust foundation of publication training is key to the development of our medical writers, providing skills and helping them develop many of the key attributes that underpin success, including attention to detail, effective storytelling, and industry compliance. Our profession is not static, and training programs need to be agile and pivot quickly to accommodate evolving industry standards, new technologies, and fluctuating client and audience needs and challenges. Staying up to date with future developments in medical writing is crucial, and we do our utmost to train and support our team and futureproof our training, so our junior writers are well equipped to excel and have fulfilling careers in the life sciences communication industry.

Medical Writing and Editing Internships: Preparing the Next Generation of Medical Communication Professionals

2024-07-15T07:05:49-07:00

Conference Education Session Report

Speakers

Barbara Gastel, MD, MPH, ELS(H), Professor, Texas A&M University, College Station, TX

Joan Affleck, MA, MBA, Associate Vice President, Head of Medical Writing, Merck & Co., Inc., Rahway, NJ

Moderator

Erica Goodoff, ELS(D), Senior Scientific Editor, The University of Texas MD Anderson Cancer Center, Houston, TX

Cultivating Passion and Curiosity in Medical Writers: The Need for Dynamic and Agile Training Programs

2024-07-30T09:49:05-07:00

My journey in writing began in 1999 as a science communicator right after grad school, before moving to regulatory writing in 2005 with minimal formal training. Early on, I was handed the ICH E3 guidance for clinical study reports and had to navigate through it on my own. My tasks varied daily, ranging from clinical data reporting to understanding submission procedures, including physically preparing documents for US Food and Drug Administration submission—the blue pronged folders are memorable. Fortunately, today’s training resources and electronic submissions make the process much smoother.

The Essential Elements of the Discussion Section of a Research Manuscript

2024-03-12T12:05:50-07:00

Many medical writers believe that the Discussion is the most difficult section of a research manuscript to write, largely because of its structural flexibility and open-ended nature. However, medical writers can build confidence in writing this section by ensuring that the Discussion includes the essential elements: a summary of the major findings, interpretations of the important findings, descriptions of the implications and applications of the findings, a discussion of the strengths and limitations of the study, details about recommended future directions, and statements of the significance and relevance of the work. These essential elements help to form an effective Discussion that showcases the study and highlights its impact to the field.

How To Read (and Write) a Book

2023-07-27T10:18:35-07:00

Mortimer Adler and Charles Van Doren’s classic How to Read a Book gives useful guidance. It explains how to evaluate whether a book is worth reading. It also gives you tips for getting the most out of the books that you read. Their advice on reading also suggests some tips for better writing. Pick an important topic and say something important about it. Do your research and organize your presentation. Keep your writing clear and simple. Make clear and reasoned arguments and anticipate the objections that your audience may raise. Above all, make sure that your title, front matter, back matter, and book cover tell the reader what your book is about and why it is worth reading.

Advance Your Writing Skills: Craft Effective Multiple-Choice Questions for Continuing Education Activities

2024-06-13T14:13:29-07:00

Health care professionals are required to participate in continuing education activities to maintain their competency and improve their clinical skills. These educational activities are often developed by medical writers who create the course content and postactivity multiple-choice questions (MCQs). The MCQs align with the learning objectives and assess the learners’ comprehension of the information and their ability to apply the knowledge in a clinical setting. The MCQs also help evaluate the educational outcome of the activity and guide future educational programs. Medical writers can craft high-quality MCQs for continuing education activities by following key recommendations that enhance knowledge and build skills in medical professionals, effectively contributing to improved patient care. This article offers an overview of the recommendations for writing effective MCQs for continuing education activities.

Table of Contents and Masthead

2024-08-02T10:23:45-07:00

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2024-09-10T14:37:09-07:00

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2024-09-10T14:34:43-07:00

Is the Hype Real? Real-Life User Experience of an Artificial Intelligence Tool for Clinical Study Report Production

2024-03-07T14:40:10-08:00

We all know that artificial intelligence (AI) is changing the world we live in, and the world of medical writing is no different. The explosion of AI is creating significant opportunities in identifying data signals, document creation, and supporting the work of medical writers. This article summarizes how the medical writers in my company, Trilogy Writing & Consulting, have been using a rule-based AI tool (that we purchase as a Software as a Service license) to augment their writing of clinical study reports (CSRs) and is a summary of a talk that I gave at AMWA’s 2023 Medical Writing & Communication Conference in Baltimore, Maryland, on October 26, 2023.

From the President: Transitions

2024-07-09T11:28:51-07:00

In medical writing, transitions are pivotal. They improve readability and, in many cases, clarify how story elements are related. They are connectors. I have been pontificating on the importance of transitions as I edit the current proposal on my desk. In looking for ways to draw the reviewer in, I use transitions to improve the flow of the document. I try out different transitions to see which ones will best show the reader how the research approach will answer the hypothesis and accomplish the objectives. So often, the original draft lacks transitions, and in finding those elements, I often find the heart of the grant.

AMWA Annual Financial Report, 2022–2023

2024-05-28T13:40:04-07:00

Following is AMWA’s financial report for the 2022-2023 fiscal year, which ended June 30, 2023.

2024 Walter C. Alvarez Award Recipient: Otis Brawley, MD

2024-07-02T14:42:27-07:00

The Walter C. Alvarez Award is bestowed on a member or nonmember of AMWA to recognize excellence in communicating health care developments and concepts to the public.

2024 John P. McGovern Award Recipient: Dr. Eliseo Pérez-Stable

2024-07-15T06:58:53-07:00

Each year the president of the American Medical Writers Association (AMWA) has the honor of selecting the recipient of one of our organization’s highest honors, the John P. McGovern Award. AMWA bestows this award to a member or nonmember of AMWA to recognize a preeminent contribution to medical communication.

2024 Golden Apple Award Recipient: Kathy Spiegel, PhD, MWC

2024-07-15T06:48:20-07:00

The Golden Apple Award is given to an AMWA member in recognition of their consistent and outstanding excellence in leading AMWA workshops.

2024 AMWA President’s Award Recipient: Barbara Gastel, MD, MPH, ELS(H)

2024-07-11T11:41:56-07:00

The recipient of the President's Award is selected by the AMWA President, and each year this award is bestowed upon a member of AMWA who has made distinctive contributions to the association at the chapter or national level.

Member Awards Committee Announces Honors

2024-07-02T12:27:58-07:00

The 2024 Member Awards Committee is pleased to recognize 3 new AMWA fellows. AMWA Fellowships are given to members for significant contributions to the goals and activities of the association. Nominees must be current members of AMWA and have been consistently active in AMWA during at least the past 5 years. This year’s fellows are Melissa L. Bogen, Kim Jochman, and Kimberly Korwek.

Officer Candidate Slate for the 2024-2025 Election

2024-07-09T11:31:24-07:00

I am honored to serve as President-Elect for AMWA this year. This afforded me the privilege to chair the Nominating Committee, who propose a slate of officers for the upcoming governance year.

The process is as follows: any interested AMWA member is invited to submit a board interest form for consideration of one of three elected offices: President-Elect, Secretary, and Treasurer. The Nominating Committee then reviews the forms and qualifications of candidates who meet the eligibility criteria and collectively agrees on a candidate for each officer position to submit to the AMWA Board of Directors (BOD) for consideration.

Innovate, Inform, And Inspire: Jazz Up Medical Communication at the 2024 Medical Writing & Communication Conference

2024-07-02T10:50:50-07:00

It's almost here! Get ready for the AMWA 2024 Medical Writing & Communication Conference in the Big Easy. This year’s conference is scheduled for October 23 through October 26 at the New Orleans Marriott hotel. Register now for the conference at the Annual Conference website (https://site.pheedloop.com/event/AMWA2024/home/).

Sneak Peek of the AMWA 2024 Medical Communication Compensation Survey Results

2024-08-07T13:02:53-07:00

As the leading professional organization for medical writers, editors, and communicators, AMWA has been conducting periodic compensation surveys since 1989. This research is designed to provide insights into income, and the factors that affect it, within the field of medical communication.

The AMWA 2024 Medical Communication Compensation Survey was conducted in March and April 2024 by an outside research firm, Association Research, Inc (ARI). ARI will deliver the final, comprehensive report to AMWA in Fall 2024. AMWA members will receive full access to the report as an exclusive member benefit. On the following pages, infographics highlighting select results from the full-time employed and full-time freelance medical communicator data sets (respectively) are presented.