Contents V38 N4 WINTER 2023 4 5 7 10 16 17 20 27 FROM THE GUEST EDITOR Preserving Ethics in a Not So Ethical World › Julie Ravo THEME ARTICLES Embracing Cultural Differences to Ensure Ethical Publication Practices › Jonathan Lee and Blair Hesp Can Industry-Funded CE/CME Be Unbiased? Current Insights on an Old Question › Eve J. Wilson SCIENCE SERIES Destigmatizing Eating Disorders with Medical Writing › Melinda D. Karth CREATIVE WRITING Resonant Melodies of Healing: A Juneteenth Symphony in Medicine › George Ongoro FREELANCE FOCUS › Brian Bass, Cathryn D. Evans, and Alex Howson Q1: How do continuing medical education/continuing education (CME/CE) medical writers balance the need for accurate scientific representation with the pressure to create content that aligns with pharmaceutical industry interests? Q2: When working on manuscripts involving multiple authors, how can medical writers help manage authorship disputes and ensure fair credit allocation following ethical guidelines? Q3: How can medical communicators navigate cultural and linguistic differences in a global health care context, ensuring their work is accu- rate and culturally sensitive? TOPICAL FEATURES The Business of Medical Writing: Communication, Leadership, and Corporate Responsibility - Part 2 › Joan Affleck, Dominic De Bellis, Brian Bass, and Jeanette M. Towles The Key to Better Regulatory Writing: Tell Your Device’s Story › Scott Dill 42 AMWAJournal.org 35Results of the 2022 AMWA DEI Survey company. Six percent of respondents work for a health care organization or provider, and 6% of respondents work for a nonprofit organization or professional society. Five percent of respondents work for a medical device company, and the remaining 3% work for a publisher or journal office (2%) or a government agency or contractor (1%). The remain- ing 11% of respondents (n = 42) work for a different type of organization or client. AMWA respondents’ primary work interests or focus areas were primarily regulatory writing and editing (32%; n = 127) and scientific publications (26%; n = 102). However, 10% of respondents (n = 39) listed their primary work inter- est/area of focus as health communication/public health/ journalism/patient education. Fewer than 10% of respon- dents selected continuing education, publications for professional audiences, promotional writing/marketing/ advertising/public relations, medical affairs, grant propos- als, and sales training as their primary work interest or focus area, and 6% of respondents selected that their primary work interest or focus area is another type of medical writ- ing or editing. Survey respondents varied in experience, but 46% (n = 193) of respondents have worked in the field from 11 to 30 years, with 23% (n = 91) working in the field from 11 to 20 years and 23% (n = 92) working in the field from 21 to 30 years. However, the percentages that do not fall into this group are still sizable, with 17% (n = 68) who have worked in the field for 0 to 2 years, 14% (n = 54) for 3 to 5 years, and 13% (n = 52) for 6 to 10 years. Finally, 10% (n = 40) of respondents have worked in the field for more than 31 years. RESIDENCY By far the largest group (91%; n = 360) of respondents who answered this question lived within the United States. The state with the highest number of respon- dents was Pennsylvania (9%; n = 33), with California and North Carolina also at 9% with 30 respondents each. Massachusetts and Texas each had 7% of respondents, or 24 respondents each. New Jersey, Illinois, and Maryland each had 5% (with 18, 17, and 16 of respondents respectively), and 4% of respondents lived in each of Colorado (n = 15), New York (n = 15), and Florida (n = 13). For respondents who lived outside the United States, the most common country of residence was Canada, with 50% (n = 17) of respondents. Remaining numbers of respondents are too low to disclose without potentially identifying members. DISABILITY Of 397 survey respondents, 17% indicated that they had a disability; the most common disabilities were chronic ill- ness (43%), mental health condition (24%), and other (12%; details were provided on the survey but are not included to preserve the privacy and identities of the respondents). Among 42 respondents who declared a disability and did not experience barriers to participation in AMWA, meth- ods of accessing AMWA services included online (64.3%) (“internet,” “computer,” and “virtually”), other (14.3%), online or other electronic medium with in-person atten- dance (ie, hybrid) (11.9%), with help of accommodation or regulation within their own limits (7.1%), with help of assis- tive device (4.8%), and via mailing list (2.4%). Of note, given that some respondents who answered no to having a dis- ability responded to this question (n = 11), there appear to be AMWA members interested in both online and hybrid formats in general and who would benefit from accessibility accommodations even though they may not consider them- selves disabled. Several respondents mentioned in their response restrictions/barriers to access, including expense (n = 2) or other barrier (n = 1). Several (n = 5) respondents also indicated that although they attend virtually when they can, they wish that there were more virtual options for par- ticipation, celebrated the greater number of virtual options available in recent years, or noted limited options for virtual participation. Twenty-three participants who answered that Figure 1. Question 14: Years of experience as a medical writer and/or editor. Total respondents = 397. 0 to 2 3 to 5 6 to 10 11 to 20 21 to 30 31 or more 0 10 20 30 Percent Responses Ye ar s of E xp er ie nc e 17 14 13 23 23 10 Figure 2. Question 7: Do you have a disability? Total respondents = 395. Yes 17% No 83% 34 20 EDITOR-IN-CHIEF Michael G. Baker, PhD GUEST EDITOR Julie Ravo, MA MANAGING EDITOR Rachel Mosher, MA SECTION EDITORS Progress in Publications Qing Zhou, PhD, ELS Regulatory Insights Jennifer Bridgers, MS, MWC Science Series Naomi Bishop, MD Statistically Speaking Thomas M. Schindler, PhD Everyday Ethics Julie Ravo, MA Freelance Focus Ruwaida Vakil, MSc CE Craft Corner Haifa Kassis, MD Practical Matters Elizabeth Kukielka, PharmD, MA, MS, MWC Around the Career Block Cecilia Petrus, MSc Technology Talk Kyla Ross, MS REGULAR CONTRIBUTORS Freelance Focus Brian Bass, MWC Melissa L. Bogen, ELS Sherri Bowen, MA, ELS Lori De Milto, MJ Cathryn D. Evans Gail V. Flores, PhD Alex Howson, PhD Phyllis Minick In the Service of Good Writing Laurie Endicott Thomas, MA, ELS Conscious Writing Crystal R. Herron, PhD, ELS EDITORS IN MEMORIAM Lori L. Alexander, MTPW, ELS, MWC Ronald J. Sanchez 2023–2024 PRESIDENT R. Michelle Sauer, PhD, ELS 2023–2024 BOARD LIAISON Qing Zhou, PhD, ELS 2023–2024 STAFF LIAISON Shari Rager, MS, CAE EXECUTIVE DIRECTOR Susan Krug, MS, CAE GRAPHIC DESIGNER Amy Boches, biographics EDITORIAL OFFICE: ManagingEditor@amwa.org. Instructions for authors available at: www.amwajournal.org. ADVERTISING: Contact marketing@amwa.org or (240) 239-0940. All advertising is subject to acceptance by AMWA and should be for products and services relevant to professional medical communicators. AMWA is not responsible for the content of advertising and does not endorse any advertiser or its products or services. SUBSCRIPTION: The AMWA Journal is published quarterly. Subscription is included with AMWA membership. Nonmember subscriptions cost is $75 per year. CONTACT: American Medical Writers Association, 9841 Washingtonian Blvd, Suite 500-26, Gaithersburg, MD 20878. Phone: (240) 238-0940; Fax: (301) 294- 9006; Email: amwa@amwa.org. The AMWA Journal is in the MLA International Bibliography and selectively indexed in the Cumulative Index to Nursing and Allied Health Literature (CINAHL) print index and the CINAHL database. The opinions expressed by authors contributing to the Journal do not necessarily reflect the opinions of AMWA or the institutions with which the authors are affiliated. The association accepts no responsibility for the opinions expressed by contributors to the Journal. ©2023 American Medical Writers Association. All rights reserved. ISSN 2163-5315 AMWA JOURNAL MISSION STATEMENT In support of the mission of the American Medical Writers Association (AMWA) and to advance the broader profession, the AMWA Journal publishes content that reflects the interests, concerns, and expertise of medical communicators. Its purpose is to inform, inspire, and motivate medical communicators. M O RE V38 N4 / 2023 TOPICAL FEATURES 31 Value of Medical Writing—Using the Regulator’s Perspective (2021 Survey Results) to Educate and Empower Medical Writers › Lisa Chamberlain James, Julia Forjanic Klapproth, Rona Claire Grunspan, Wayne Beazley, Brian Bass, Joan Affleck, Julia Cooper, Caroline Lilley, and Amy Wollish 34 Results of the 2022 AMWA DEI Survey › Karla Haack, Toni Willis, and Jeanette Towles 38 CONSCIOUS WRITING Best Practices to Guide Decisions of Authorship and Author Order in a Research Manuscript › Crystal R. Herron 42 ORIGINAL RESEARCH Data Mining FDA Docket 2019-N-1482: Content, Sentiment, and Metadata › Michael J. Madson and Andrew Madson AMWA NEWS 48 From the President › R. Michelle Sauer 50 Introducing the 2023–2024 Board of Directors › R. Michelle Sauer 51 CALENDAR OF MEETINGS Contents http://www.amwajournal.org