In July 2023, the American Medical Writers Association (AMWA) developed a survey to understand the impact of technology on the role of medical writers in clinical and regulatory document development. The survey was administered using SurveyMonkey to individuals responsible for leading, training, or developing a medical writing team. Respondents were mostly regulatory writers (96%) working in pharmaceutical/biotechnology/medical device or contract research organizations (88%). Most were using technology (65%) and almost all were planning to implement authoring technology (95%). New roles for medical writers, training methods for implementation of artificial intelligence (AI), and validation of the AI output were also discussed. Quality and accuracy of the AI output were the most important considerations of the respondents with transparency and disclosure as the least important. In general, the survey respondents felt that the impact of technology in the medical writing field was an important and timely topic for AMWA to address.
{"title":"Understanding the Impact of Technology on Medical Writing: AMWA Survey Results from June 2023","authors":"Karen Rutkowski, Kenneth Shapiro, Laura Sheppard","doi":"10.55752/amwa.2024.331","DOIUrl":"https://doi.org/10.55752/amwa.2024.331","url":null,"abstract":"In July 2023, the American Medical Writers Association (AMWA) developed a survey to understand the impact of technology on the role of medical writers in clinical and regulatory document development. The survey was administered using SurveyMonkey to individuals responsible for leading, training, or developing a medical writing team. Respondents were mostly regulatory writers (96%) working in pharmaceutical/biotechnology/medical device or contract research organizations (88%). Most were using technology (65%) and almost all were planning to implement authoring technology (95%). New roles for medical writers, training methods for implementation of artificial intelligence (AI), and validation of the AI output were also discussed. Quality and accuracy of the AI output were the most important considerations of the respondents with transparency and disclosure as the least important. In general, the survey respondents felt that the impact of technology in the medical writing field was an important and timely topic for AMWA to address.","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140241357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
There is ample evidence across many domains that writing in plain language saves time or money or both for readers and organizations. Communication in plain language is generally more effective and produces better outcomes than traditional writing. In many contexts, readers prefer plain language over traditional writing styles, and use of plain language fosters the building of trust. Finally, the process of translating is usually more efficient for plain language documents. In July 2023, after many years of development, discussion, and alignment, the International Organization for Standardization (ISO) published a standard for plain language. This publication makes an internationally developed and agreed-upon standard available to all people interested in the use of plain language. It is an authoritative source developed by plain language practitioners, linguists, technical writers, designers, and text creators from many different countries. The standard will help all writers (authors) to make their texts (documents, web pages, etc.) most useful for the intended audiences (readers, users). It applies to most written languages and reflects the most recent research on plain language and the experience of plain language experts.
{"title":"The Making of the International Standard for Writing in Plain Language ISO 24495-1: Its Usefulness, Content, and How It Came into Existence","authors":"Thomas Schindler","doi":"10.55752/amwa.2024.333","DOIUrl":"https://doi.org/10.55752/amwa.2024.333","url":null,"abstract":"There is ample evidence across many domains that writing in plain language saves time or money or both for readers and organizations. Communication in plain language is generally more effective and produces better outcomes than traditional writing. In many contexts, readers prefer plain language over traditional writing styles, and use of plain language fosters the building of trust. Finally, the process of translating is usually more efficient for plain language documents.\u0000In July 2023, after many years of development, discussion, and alignment, the International Organization for Standardization (ISO) published a standard for plain language. This publication makes an internationally developed and agreed-upon standard available to all people interested in the use of plain language. It is an authoritative source developed by plain language practitioners, linguists, technical writers, designers, and text creators from many different countries. The standard will help all writers (authors) to make their texts (documents, web pages, etc.) most useful for the intended audiences (readers, users). It applies to most written languages and reflects the most recent research on plain language and the experience of plain language experts.","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"51 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140242751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
What is a niche? What are the rewards and risks of nourishing a niche? How do you find a niche? As freelance medical writers, or writers considering freelance work as an option, we have to ask ourselves what kind of medical writing we are going to do. Are we going to offer a broad mix of services or tap a specialty niche? This article will help you weigh the pros and cons of whether to specialize as a freelance medical writer and how you can get started.
{"title":"Nourish Your Niche: The Rewards and Risks of Specialized Medical Writing","authors":"Alex Howson","doi":"10.55752/amwa.2024.327","DOIUrl":"https://doi.org/10.55752/amwa.2024.327","url":null,"abstract":"What is a niche? What are the rewards and risks of nourishing a niche? How do you find a niche? As freelance medical writers, or writers considering freelance work as an option, we have to ask ourselves what kind of medical writing we are going to do. Are we going to offer a broad mix of services or tap a specialty niche? This article will help you weigh the pros and cons of whether to specialize as a freelance medical writer and how you can get started.","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"22 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140243302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robert Panek, Sara Fernandes, Mauro Meloni, Gregory Morehouse, Rona Grunspan
Lean writing workflow processes can streamline development of complex documents, including protocols and other regulatory submissions. This paper outlines standard development timelines and describes useful lean writing workflow methods and tools to reduce protocol development timelines without sacrificing document quality. We present the results of a survey completed by 75 Medical writers (MW) that reveal the strategies used during document preparation and use real case scenarios (protocol development) that illustrate how innovative tools and approaches can be efficiently used to create a lean writing workflow process. Software tools (e.g., proofreading assistance, citation manager, collaborative authoring and reviewing) were widely accepted and used during protocol development according to the MWs surveyed. Most of the surveyed writers (62%) hypothesized a reduction in production time by about 25%. Efficient collaborative work across different time zones had a marked impact on shortening timelines while maintaining production of high-quality documents. Real case scenarios were used to illustrate how innovative tools and approaches can positively impact timelines and efficiently create a lean writing workflow process regardless of therapeutic area. The real case scenarios showed that protocol development time can be decreased by about 26% without compromising the quality of the document. This shows that software tools, templates, checklists, and collaborative writing were more impactful than hypothesized by the MWs included in the survey. With clear workflow processes, roles, and responsibilities backed by innovative software applications, template guidelines, and collaborative work processes, MWs can overcome common development challenges and improve their lean regulatory writing skills.
{"title":"Using Innovative Tools and Lean Writing Workflow Processes to Accelerate Regulatory Document Writing","authors":"Robert Panek, Sara Fernandes, Mauro Meloni, Gregory Morehouse, Rona Grunspan","doi":"10.55752/amwa.2024.254","DOIUrl":"https://doi.org/10.55752/amwa.2024.254","url":null,"abstract":"Lean writing workflow processes can streamline development of complex documents, including protocols and other regulatory submissions.\u0000This paper outlines standard development timelines and describes useful lean writing workflow methods and tools to reduce protocol development timelines without sacrificing document quality.\u0000We present the results of a survey completed by 75 Medical writers (MW) that reveal the strategies used during document preparation and use real case scenarios (protocol development) that illustrate how innovative tools and approaches can be efficiently used to create a lean writing workflow process.\u0000Software tools (e.g., proofreading assistance, citation manager, collaborative authoring and reviewing) were widely accepted and used during protocol development according to the MWs surveyed. Most of the surveyed writers (62%) hypothesized a reduction in production time by about 25%. Efficient collaborative work across different time zones had a marked impact on shortening timelines while maintaining production of high-quality documents.\u0000Real case scenarios were used to illustrate how innovative tools and approaches can positively impact timelines and efficiently create a lean writing workflow process regardless of therapeutic area.\u0000The real case scenarios showed that protocol development time can be decreased by about 26% without compromising the quality of the document. This shows that software tools, templates, checklists, and collaborative writing were more impactful than hypothesized by the MWs included in the survey.\u0000With clear workflow processes, roles, and responsibilities backed by innovative software applications, template guidelines, and collaborative work processes, MWs can overcome common development challenges and improve their lean regulatory writing skills.","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"27 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140244928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Roads Leading to Approval: The Right Level of Detail for CMC Submissions","authors":"Sidonie Jones","doi":"10.55752/amwa.2024.344","DOIUrl":"https://doi.org/10.55752/amwa.2024.344","url":null,"abstract":"Conference Education Session Report\u0000Speakers\u0000Helen (Nellie) Forwood, MA, RAC, CQE, Associate Director Regulatory Writing, Certara, Rockland, DE\u0000Carlos Rousselin, BS, Associate Principal Regulatory Writer, Certara, Nashville, TN","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"5 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140241760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Harmonies of Justice: Reflections on Virtue and Equality","authors":"George Ongoro","doi":"10.55752/amwa.2024.296","DOIUrl":"https://doi.org/10.55752/amwa.2024.296","url":null,"abstract":"","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"15 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140243348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Conference Education Session Report Speakers Cindy van Dijk, Principal, Scientific Communications Allison Kickel, President and Founder, Bonum Continuing Education
大会教育会议报告主讲人辛迪-范戴克，科学传播负责人艾莉森-基克尔，博能继续教育总裁兼创始人
{"title":"Social Media Continuing Medical Education: Next Steps","authors":"Laura Tibaquirá","doi":"10.55752/amwa.2024.343","DOIUrl":"https://doi.org/10.55752/amwa.2024.343","url":null,"abstract":"Conference Education Session Report\u0000Speakers\u0000Cindy van Dijk, Principal, Scientific Communications\u0000Allison Kickel, President and Founder, Bonum Continuing Education","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"21 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140242683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joan Affleck received the 2023 Harold Swanberg Distinguished Service Award, named in honor of one of the founders of AMWA. This award is presented to an active AMWA member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. At the 2023 AMWA Medical Writing & Communication Conference, Joan Affleck accepted the award at a plenary session and presented a MedWrite Talk entitled “Living Your Legacy.”
{"title":"2023 Harold Swanberg Distinguished Service Award","authors":"Joan Affleck","doi":"10.55752/amwa.2024.332","DOIUrl":"https://doi.org/10.55752/amwa.2024.332","url":null,"abstract":"Joan Affleck received the 2023 Harold Swanberg Distinguished Service Award, named in honor of one of the founders of AMWA. This award is presented to an active AMWA member who has made distinguished contributions to medical communication or rendered unusual and distinguished services to the medical profession. At the 2023 AMWA Medical Writing & Communication Conference, Joan Affleck accepted the award at a plenary session and presented a MedWrite Talk entitled “Living Your Legacy.”","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"27 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140241825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The Walter C. Alvarez Award is named in honor of Walter C. Alvarez, MD, a pioneer in the field of medical communication. The award is presented to either a member or nonmember of the American Medical Writers Association (AMWA) to honor excellence in communicating health care developments and concepts to the public. The Alvarez Award is presented during AMWA’s Medical Writing & Communication Conference.
沃尔特-阿尔瓦雷斯奖（Walter C. Alvarez Award）是为纪念医学传播领域的先驱者沃尔特-阿尔瓦雷斯（Walter C. Alvarez）医学博士而命名的。该奖项授予美国医学写作者协会（AMWA）的会员或非会员，以表彰他们在向公众传播医疗保健发展和理念方面的卓越成就。阿尔瓦雷斯奖在 AMWA 的医学写作与传播大会期间颁发。
{"title":"2023 Walter C. Alvarez Award Address","authors":"Katelyn Jetelina","doi":"10.55752/amwa.2024.320","DOIUrl":"https://doi.org/10.55752/amwa.2024.320","url":null,"abstract":"The Walter C. Alvarez Award is named in honor of Walter C. Alvarez, MD, a pioneer in the field of medical communication. The award is presented to either a member or nonmember of the American Medical Writers Association (AMWA) to honor excellence in communicating health care developments and concepts to the public. The Alvarez Award is presented during AMWA’s Medical Writing & Communication Conference.","PeriodicalId":503877,"journal":{"name":"AMWA Journal","volume":"19 2‐3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140244271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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