Communicating Science to the Public

11/3/2022 9:30 AM - 11:00 AM

Presenter: Susan Aiello, DVM, ELS

In this session, we will consider best practices and strategies for communicating science to the public, both for written pieces and for in-person or virtual presentations. Individual topics include understanding the audience, determining the message, and effectively using language and visuals. Challenges and potential pitfalls to be avoided will be described. Time will be devoted to handling scientific uncertainty and managing crisis communications, as well as dealing with journalists and the media. This usually makes for a lively discussion, so come prepared to share!

Learning Objectives:

• Identify three techniques to engage and develop trust by lay audiences.
• Describe strategies for crafting a memorable and understandable message.
• Discuss best practices for handling media interviews.

Content Area: Health communication

Target Audience: All levels

How to Develop Efficient Submissions and Successfully Lead Submission Teams

11/3/2022 9:30 AM - 11:00 AM

Presenter: Mark Bowlby, MS, PhD, Brenda Taylor & Laura Sheppard, MBA, MA

Modern regulatory submissions are often very complex; therefore, having a knowledgeable person  with regulatory writing expertise to lead a cross-functional team through the regulatory submission process is becoming a necessity.   In conjunction with the Regulatory Affairs Lead, a Regulatory Writing Submissions Lead (ie, Submission Lead) guides the team in development of a comprehensive eCTD content plan and the strategy to align document authoring, reviewing, and publishing activities to meet the targeted submission date.   Submission Leads are also essential in developing a submission strategy along with the Regulatory Affairs Lead, ensuring consistency in messaging, and adherence to regulatory requirements. Early planning for multiple Health Authority submissions and best practices discussions are key tools for success.  This session will explain the Submission Lead role, benefits the role brings to a team, and the developmental pathway to becoming a Submission Lead.

Learning Objectives:

• Describe the responsibilities that comprise the typical Submission Lead role.
• Identify key components of the developmental pathway to become a Submission Lead.
• Apply lateral leadership principles to submission team engagements.

Content Area: Regulatory writing

Target Audience: All levels

Training Medical Writing Leaders

11/3/2022 9:30 AM - 11:00 AM

Presenter: Julia Forjanic Klapproth, PhD & Angela Russell Winnier, PhD

In our current global, remote working environment, the value of medical writing depends on excellent interpersonal, active listening, and influencing skills in addition to strong technical writing ability. Much of our existing training programs focus on technical/knowledge-based competencies. But, developing medical writers to be leaders (of a project, of other writers) should be an essential focus. As for any role, good leaders do not emerge fully formed from the seed of a medical writer. There is a specific skill set needed to make a great leader/people manager capable of successful collaborations with cross-functional, global teams and influential development of other medical writers. This talk will summarize key skills medical writing leaders need and the characteristics of the training environment that promote development of these skills. It will also provide early insights from an AMWA working group tasked with identifying/supporting the training needed to create strategic leaders.

Learning Objectives:

• Recognize the unique skill set needed to make a good medical writing leader
• Understand what is needed to teach someone the skills for leadership
• Discuss what the AMWA working group for the Value of Medical Writing has learned about medical writing leadership (optional – depending on the material available from the working group)

Content Area: Career development

Target Audience: Mid-career (5 to 8 years) & Advanced (More than 8 years)

Editing Your Own Work (After You’ve Read It 1000 Times)

11/3/2022 2:00 PM - 3:00 PM

Presenter: Hope Lafferty, AM, ELS

Medical writers don’t only write. We’re researchers, content developers, project managers, multilevel editors, proofreaders, and publishers. Each role requires a different way of thinking. Writers and managers view projects strategically; editors and proofreaders approach projects tactically. Switching between these different ways of thinking can prove challenging---especially when we’re exhausted, fed up, and under deadline.    Attendees will gain both strategies and tactics to catch embarrassing or compromising mistakes without glazing over so that they may produce impeccable documents that are error-free, wince-free, and easier to read.

Learning Objectives:

• Identify common writing mistakes that are easy to miss
• Avoid common problems in how we review our work
• Incorporate best editorial practices into an already overbooked workload—to approach documents with fresh eyes and spot mistakes with greater speed and accuracy

Content Area: Career development

Target Audience: All levels

Nonclinical Regulatory Writing for Biologics: Case Study of a Regulatory Submission for Emergency Approval of a SARS-CoV-2 Monoclonal Antibody Treatme

11/3/2022 2:00 PM - 3:00 PM

Presenter: Ashley Roberts & Kerstin Hofmeyer

In the evolving landscape of biotherapeutic development, expertise in nonclinical regulatory writing for biologics, such as monoclonal antibodies, is critical to draft documents for a therapeutic submission to support the initiation of clinical trials. In the course of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) global pandemic, nonclinical data played a critical role in the design and implementation of monoclonal antibody treatments used in adaptive clinical protocols required to gain emergency use authorization and subsequent regulatory approval. This session will describe how nonclinical content was compiled, including the accelerated document process strategy encompassing iterative workflows and lean authoring, allowing for a successful submission in record time.

Learning Objectives:

• Describe nonclinical content for biologics (monoclonal antibodies) with a focus on exogenous targets in infectious disease
• Discuss accelerated document submission strategy
• Define principles of lean authoring and of the iterative workflow process in support of accelerated submission drafting

Content Area: Regulatory writing

Target Audience: All levels

WS #09: Writing Clinical Study Report Lay Summaries--A Survivor's Guide

11/3/2022 2:00 PM - 5:00 PM

Presenter: Lisa Chamberlain James, PhD (cantab.)

Writing plain language summaries of clinical trial results (the lay summary) is challenging but is now legally required in the European Union, with the United States set to follow suit. This workshop provides an overview of the problems with writing in plain language, a discussion of the challenges of describing real data for an onspecialist audience, and a summary of practical tips and explanations for how to approach the requirements. In-workshop activities: participants will develop specific sections of a lay summary. The workshop focuses on the requirements of the EU regulation specifically, but the skills and principles taught can be applied to any plain language document.

Content Area: Regulatory

WS #11: How to Interpret and Write About Clinical Trial Data

11/3/2022 2:00 PM - 5:00 PM

Presenter: Kimberly Jochman, PhD, RAC

1When writing about clinical trial data, the days of simply repeating numbers from a table have passed. Whether you are writing about data for regulatory reviewers, journal readers, patients, or other groups, your audience wants and deserves to read interpretations about what the data mean. But how does one write content that accurately and effectively interprets the data? In this workshop, the science (and art!) of interpreting data from clinical trials will be discussed and practiced, with a focus on understanding different statistical approaches to gain confidence in what can (and cannot) be said about the data. Techniques for getting stakeholder input and alignment on key interpretations and messages will also be presented. Embrace your role as a data interpreter with the knowledge and ability to lead your team through the creation of clear, accurate documents that go beyond the numbers in a table.

Content Area: Regulatory

Clinician to Medical Writer

11/3/2022 4:00 PM - 5:00 PM

Presenter: Shawn Watson, PharmD, PhD, BCPS & JoAnna Pendergrass, DVM

Clinically trained professionals hold significant domain expertise and are often already skillful medical communicators. Sometimeslong-term clinical practice is incongruent with one’s lifestyle, professional ambitions, and personality style. Medical writing is anexcellent way to leverage that prior training and experience to communicate complex medical concepts intelligently and succinctly tovarious stakeholders, including other medical professionals, regulators, patients, corporate leadership, investors, and payers. Thispresentation will discuss the journeys from health care professionals (HCP) who became medical writers, including how they made thecareer transition, how they incorporate their insights as HCPs into medical writing deliverables, and what the trajectory can look like forsomeone in this situation.

 

Learning Objectives:

• Discuss key traits, experiences, and training that clinicians can effectively leverage as medical writers
• Specify unique career options for clinicians seeking to transition to medical writing
• Discuss the similarities and differences between freelance and employed medical writing
• Specify steps for transitioning from clinical practice to medical writing

Content Area: Career development

Target Audience: New/Entry level (0 to 5 years)

MedWrite Talks

11/3/2022 4:00 PM - 5:00 PM

The 10 Most Common Misconceptions New Freelance Medical Writers Have & Why They're Wrong

Sophie Ash, BSc (Hons), DipION, Freelance Medical Writing Coach, Prospology, Toronto, Ontario

It’s not uncommon for fresh-faced freelancers to feel overwhelmed when embarking on entrepreneurship for the first time. Suddenly faced with the prospect of self-promotion, branding, sales, and negotiation, it’s easy to lose momentum, or get stuck before you’re even out of the gate. “How much should I charge?”, “Is networking essential for my success?”, and “What should I put in my portfolio?” are just a handful of the questions that are probably running through your jittery mind. Rest assured, this is totally normal. If you act now, you can get back on the straight and narrow, well on your way to increased freedom and flexibility in your freelancing business. It’s time to show up for yourself and quit floundering. Avoid making the ten most common mistakes that new freelance medical writers make by learning from others’ business blunders.

Content Area: Career development

 

The Role of Medical Writing in Patient Centricity

Heather Graham, Vice President, Regulatory Writing and Scientific Publications, Certara, Toronto, ON

Patient-centricity is not just a topic for Clinical Science and Medical Affairs! As Patients and Patient Advocacy Groups (PAGs) become more connected, informed, and organized, how can we as Regulatory and Medical Writers leverage our roles to ensure the patient voice is accurately represented in submission documents and overall assessments of benefit-risk. 

Content Area: Regulatory writing

 

Your Next Awesome Job is My Mission

Tatyana Wanderer, PhD, Executive Director and Head of Medical Writing, Syros Pharmaceuticals, Inc., Nashville, TN

Demand for medical writers is high and supply of new writers is still catching up. The good ones are in demand, expect frequent promotions, and make frequent lateral jumps. Old mostly HR-driven approaches to retention (e.g., golden handcuffs) are not working. I propose a new employee-focused management approach that embraces reality of turnover without sacrificing product quality, professional development, or continuity of knowledge.

Content Area: Regulatory writing

So You Want to Put Your Science on Social Media?

11/3/2022 4:00 PM - 5:00 PM

Presenter: Ayanna Tucker, MPH

Attendees will learn how to create a social media presence for their research, institution or individual work from the managers of award-winning social media accounts at Johns Hopkins Medicine. We will show you how to make your own niche in the world of social media, how to reach users with your research, how to tell if your account is performing well and how to optimize content based on performance. To make this as interactive as possible, we will provide a customizable, step by step guide so that by the end of the session attendees have a take-home roadmap to guide their own accounts. The guide will be distributed to attendees as a worksheet to take notes with as they follow along through the sections of our presentation. We will provide time for attendees to get feedback from the group & panelists on their completed roadmap.

Learning Objectives:

• Define the audience for your social media account
• Establish a tone of voice for your posts
• Identify metrics to employ for analyzing the effectiveness or success of your social media account
• Develop a content strategy guided by your success measures
• Complete a take-home roadmap to use as a reference while managing or launching a social media account

Content Area: Health communication

Target Audience: All levels

Consistency in Regulatory Documents: Writing & Managing

11/4/2022 9:00 AM - 10:30 AM

Presenter: Kleopatra Kouroupaki, Dr. phil. nat.

Qualified regulatory medical writers (RMW) hold a broad set of writing skills as well as strength in logical thinking and project management. When working under demanding timelines in dossier submission projects (DSP), sufficient training can help you stand out as an excellent RMW. If you have interest in high-profile DSP, your skillset should ideally cover two aspects: writing of high quality documents and managing of large teams and timelines. Specialized tips on authoring quality documents without inconsistencies that impair the review and advice on how to act as a catalyst in successful team collaborations during DSP could place you among the most impactful team members in such projects and allow you to rise above the average RMW.

Learning Objectives:

• Understand and practice how to write high-quality, inconsistency-free documents.
• Appreciate how consistently authored documents in a dossier elevate the quality of the submission and increase the chance of success.
• Learn how to improve your interpersonal communication skills and propose writer-friendly, efficient project timelines.

Content Area: Regulatory writing

Target Audience: Mid-career (5 to 8 years) & Advanced (More than 8 years)

The Reluctant Manager

11/4/2022 9:00 AM - 10:30 AM

Presenter: Susan Aiello, DVM, ELS

If you’re like many medical communicators, managing words comes easier than managing people. But in most organizations, taking on people management usually becomes part of the job, especially if you want to move up and/or have more responsibility. If you are not looking forward to (or even dread) the managerial role, this session is for you. We’ll explore the qualities techniques, and strategies used by good managers to bring out the best in both themselves and others. Note: This session is about people management, not project management.

Learning Objectives:

• Identify three qualities that managers should cultivate in themselves for better managerial performance.
• Describe techniques used by good managers to enable their direct reports to function at their best.
• Explain how to manage people who are in positions or roles that you have never done yourself.

Content Area: Leadership/management

Target Audience: Mid-career (5 to 8 years) & Advanced (More than 8 years)

WS #14: Composing Narratives for Safety and Adverse Event Reporting

11/4/2022 9:00 AM - 12:00 PM

Presenter: Jennifer Bridgers, MS, MWC

Well-written narratives are cohesive, concise, and clear. This workshop is designed to enhance the skills needed to compose high-quality narratives. Key elements in safety reporting, correct use of medical language, and organization of data for a well-written narrative are addressed. In addition, best practices and realistic constraints are discussed. In-workshop activities: participants will engage in exercises to build their skills in composing narratives.

Content Area: Regulatory

WS #16: Introduction to Statistics for Medical Communicators

11/4/2022 9:00 AM - 12:00 PM

Presenter: Bart Harvey, MD, PhD

This workshop is designed for participants who have little or no background in statistics. Elementary statistical concepts needed to understand medical and scientific articles will be covered, including types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and Student’s t test. Emphasis will be placed on understanding statistical presentations and on reporting statistical information, not on calculations or mathematical explanations.

Content Area: Core Knowledge

Attention! How to Harness It for Productivity and Deep Work

11/4/2022 11:00 AM - 12:00 PM

Presenter: Ann Winter-Vann, PhD & Kelly Kilibarda, PhD

Whether diving into source data, reviewing the literature, or determining how to convey complex medical concepts to a specific audience, medical writers and editors require periods of intense concentration to do their best work. However, the tools that facilitate our work also create distractions that prevent us from focusing on a single task. In this session, we will present the nature of attention, the difference between deep work and shallow work, and the mental and financial costs of multi-tasking and interruptions. We will discuss the ways that our lives and jobs set the expectation of immediate responsiveness and the ways in which modern technology is designed to capture (and keep) our attention. Finally, we will present strategies to identify the key distractions in our own lives and suggestions on how to minimize these to create the opportunity for periods of uninterrupted focus.

Learning Objectives:

• Understand the concept of deep work and the negative effect of constant interruption.
• Define the factors in your work day that pull you away from cognitively intensive tasks
• Identify strategies to minimize distractions and improve your productivity by cultivating a mindset and environment in which deep work can thrive

Content Area: Career development

Target Audience: All levels

DIY Graphics for Medical Writers

11/4/2022 11:00 AM - 12:00 PM

Presenter: Laurie LaRusso, MS, ELS

Clean, crisp graphics that highlight important data and convey key messages are in high demand. Medical writers need not fear figures, panic about posters, or stress over slides. We can easily create high-quality visual elements without enlisting the help of a graphic designer, incurring the expense of high-end graphics software or enduring a long learning curve. Learn how to create top-notch figures, charts, and diagrams for slides, posters, and manuscripts using only Microsoft PowerPoint and its embedded Excel features. This program will address when to use visual data presentation, which graphical format to use, and demonstrations of how each type of graphic is created.

Learning Objectives:

• Identify opportunities for visual data presentation
• Choose the optimal graphical format to present specific types of data
• Apply basic principles of graphic design to produce clean, crisp graphics that highlight important data and convey key messages

Content Area: Scientific publications

Target Audience: All levels

New EU CTR Landscape Changes for Medical Writing

11/4/2022 11:00 AM - 12:00 PM

Presenter: Dr. Simin Takidar, Dr. Lisa Chamberlain James, Dan Bilodeau, Thomas Wicks & Shirisha Kanthala

In early 2022, the European Union Clinical Trials Regulation (EU CTR) 536/2014 came into application and changed the landscape for how organizations plan and conduct their clinical trials in EU Member States. The new EU CTR is designed to harmonize the processes for application and reporting of clinical trials across EU, but the changes are numerous, technically demanding, and difficult to navigate. In this session we will have a panel of EU CTR experts join us as our guides to lead us through this new terrain. We will discuss changes to reporting processes and documents that are often prepared by medical writers, including plain language lay summaries, and attendees will have the opportunity to ask questions and learn from the early experiences of others. 

Learning Objectives:

• Learn about how the EU CTR changes apply to medical writing deliverables
• Define the parameters of plain language lay summaries in the context of EU CTR
• Apply the principal changes from EU CTR to individual organizational processes

Target Audience: Mid-Career to Advanced

A Journalistic Approach to Writing Better Abstracts

11/4/2022 2:00 PM - 3:00 PM

Presenter: Susan Aiello, DVM, ELS

After the title, the most read part of a scientific paper is the abstract. Can we write abstracts better and more efficiently? Yes, we can. The writing method commonly used in news reporting and other journalism environments is a useful technique not only to glean the essential elements of an abstract from a paper but also to organize the abstract for rapid comprehension by the reader. Time permitting, we’ll discuss characteristics of a good title, too.

Learning Objectives:

• Define the function and order of each component of the abstract of a scientific paper.
• Identify the content parallels between scientific abstracts and news articles.
• Apply a standard newswriting technique to efficient abstract preparation.

Content Area: Scientific publications

Target Audience: New/Entry level (0 to 5 years) & Mid-career (5 to 8 years)

Elegant Timeline Tracking and Resourcing with the Tools You Already Have

11/4/2022 2:00 PM - 3:00 PM

Presenter: Tatyana Wanderer, PhD & Joy Grabenstein

Regulatory writing groups small and large all face the challenge of resource management in the context of constantly changing project timelines. While custom software packages may be accessible to larger companies, smaller companies frequently struggle with frustrating and ineffective solutions. At Syros we used Power BI software that is already available with MS Office to create dynamic and elegant dashboards that enable visualization of ongoing and upcoming projects and efficient resourcing across writing and reviewing staff. We would like to share our experience with our colleagues with the hope that this new approach may be helpful in their organizations.

Learning Objectives:

• Understand pluses and minuses of most popular approaches to timeline tracking and resource management
• Understand how a new approach using Power BI software with Excel can be leveraged to create convenient dashboards for timeline tracking and resource management

Content Area: Regulatory writing

Target Audience: Mid-career (5 to 8 years)

Using Storytelling to Capture Exceptional Care and Build Audience Trust

11/4/2022 2:00 PM - 3:00 PM

Presenter: Ben Riggs

Storytelling has a celebrated position in content-marketing strategies. And healthcare systems and organizations have long had access to the fertile landscape of human events that make for the best stories—in video and in print. But healthcare marketing approaches to content have been slow to adopt a storytelling-centric approach to content in public-facing spaces (website, social media, print collateral, etc.). And they miss the opportunities for inculcating positive brand identity, elevating employee pride, and increasing patient confidence in service-line offerings. Many content approaches adopt a form of reporting, writing, and production that leads to flattened, flimsy stories empty of emotion, vividness, and humanity. The rhetorical strategies from the genre known as narrative nonfiction can free healthcare content producers to report on, capture, and show compelling stories of patient experience and care-provider excellence that catapult the tangible and intangible returns that content-marketing strategies aim to garner.

Learning Objectives:

• Address the limitations of conventional content approaches.
• Show what narrative-nonfiction–shaped storytelling looks and sounds like.
• Offer concrete strategies and approaches to using the distinctions of narrative nonfiction.

Content Area: Health communication

Target Audience: New/Entry level (0 to 5 years)

A Medical Writer’s Guide to Using Master Protocols

11/5/2022 9:00 AM - 10:00 AM

Presenter: Shawn Watson, PharmD, PhD, BCPS

Umbrella protocols include multiple studies in a single protocol and provide a great deal of leverage to companies conducting these studies because they allow different cohorts to run concurrently, accelerate overall clinical development, and reduce development costs. Nonetheless, their designs are quite complicated and present unique challenges to a regulatory writer. This presentation will focus on these challenges, with an emphasis on single-ascending dose-escalation (SAD) and multiple-ascending dose-escalation (MAD), drug-drug interaction, pharmacokinetic lead in, bioavailability, and thorough QT studies. In addition to discussing what information these studies provide, the presentation will also describe the rationale for combining these studies into a single protocol, provide strategic consideration for combining these studies, and provide tactical guidance for writing these protocols.

A single ascending dose (SAD) study is often performed as a first in human study, which randomizes healthy subjects to either a dose of study drug based on preclinical toxicology or a placebo. Assuming that a compound is safe and well tolerated, escalation to higher doses occurs. Multiple ascending dose (MAD) studies leverage data from SAD cohorts to select dose levels and dosing intervals that are predicted to be safe. Both SAD and MAD studies require intensive safety monitoring and typically involve evaluation of pharmacokinetic assessments.

Learning Objectives:

• Provide an overview of SAD and MAD studies, including what information these studies provide,
• Describe the rationale for combining SAD and MAD studies into a single protocol,
• Provide strategic considerations when combining these studies, and 4) offer tactical guidance for writing these combined study protocols.

Content Area: Regulatory writing

Target Audience: Mid-career (5 to 8 years)

Inclusive Language: Best Practices and Practical Applications for Medical Writers and Editors

11/5/2022 9:00 AM - 10:00 AM

Presenter: Leila Emery, MA & Joyce Hicks

In this session, Leila Emery and Joyce Hicks will draw upon their experience in diversity, equity, and inclusion initiatives to instruct participants on the process of adapting inclusive language best practices in medical communication. After learning about the importance of using inclusive language, participants will hear how the instructors solicited examples of inclusive language from their medical writing and editing colleagues as well as their fellow Diversity and Inclusion Council members, drafted an inclusive language section of their company’s in-house style guide, sought feedback and buy-in on these style guide updates, and began incorporating inclusive language best practices into their daily work. Participants will also hear about the challenges and successes involved in adapting these best practices. Ultimately, participants will come away with a greater understanding of why using inclusive language is crucial in contemporary medical communication and how these best practices can strengthen medical writing and editorial teams.

Learning Objectives:

• After the session, participants will better understand the importance of inclusive language, be able to anticipate both the challenges to and benefits of communicating inclusive language guidelines to medical writing and editorial teams, and know how to begin incorporating inclusive language best practices in their daily work.

Content Area: Health communication

Target Audience: All levels

The Use of Artificial Intelligence and Machine Learning in Clinical Research and Health Care

11/5/2022 9:00 AM - 10:00 AM

Presenter: J. Kelly Byram, MS, MBA, ELS, CEO

Artificial intelligence (AI) and machine learning (ML) methodologies have quickly evolved in recent years, and AI is increasingly used in drug development, clinical research, and health care. As AI research rapidly expands across therapeutic areas and ultimately into clinical care, medical communication professionals will need a working knowledge of AI to effectively communicate about these tools to their audiences. Learn the basics of AI and ML and discuss both current AI tools and their implementation and projected future applications of AI.

Learning Objectives:

• Discuss the basics of AI and ML technology.
• Describe how AI tools are developed and implemented.
• Identify current and emerging applications of AI in clinical research and health care.

Content Area: Core knowledge/skills

Target Audience: All levels

WS #19: Organizing Principles for Journal Manuscripts Reporting Original Research

11/5/2022 9:00 AM - 12:00 PM

Presenter: Barbara Gastel, MD, MPH

Medical writers who write and edit manuscripts for medical journals need to understand the accepted principles for organizing and preparing original research reports for publication. Many journals require authors to follow these principles. This workshop focuses on describing the function and content of each section of a medical research manuscript. A brief discussion will be included of techniques for targeting appropriate journals for the message. Participants will learn how to use the organizational principles to clarify messages and how to critique manuscripts on the basis of strengths and weaknesses of organization. A pre-workshop assignment will be the basis for discussion during the workshop.

Content Area: Scientific Publications

WS #21: Basics of Epidemiology

11/5/2022 9:00 AM - 12:00 PM

Presenter: Bart Harvey, MD, PhD

Designed for experienced medical writers, this combination of lecture and group exercises will be help the participants learn to interpret basic epidemiological data. The focus will be on the critical evaluation of reported medical findings and the application of epidemiological concepts to improve the participant's writing. Measures of disease occurrence, research designs, and causality will be discussed. The workshop leader will use examples from clinical medicine, public health, and pharmacoepidemiology.

Content Area: Core Knowledge

Being a Chapter Officer: Volunteering as Professional Development

11/5/2022 11:00 AM - 12:00 PM

Presenter: Andra Steinbergs, MA, Erica Goodoff, ELS(D) & Terry Nugent

As members of the American Medical Writers Association (AMWA), we enjoy an expansive network of educational, networking, and professional resources. Within AMWA, regional, volunteer-led chapters provide additional educational and networking events. Further, these chapters offer the invaluable opportunity to volunteer as a chapter officer, which combines the educational and networking benefits of AMWA with the perks of professional development. In this panel presentation, three chapter officers share their stories of how they became officers, describe the day-to-day life of an officer, and explain how being an officer has affected their professional careers. This panel provides perspectives from a Treasurer, President-Elect, and President, representing various geographic regions, a broad span of professional expertise, and a range of non-professional responsibilities. Through stories of lived experience, this session demonstrates how volunteering as a chapter officer can reinforce your existing skills, expand your professional network, and boost your professional development.

Learning Objectives:

• Recognize how responsibilities and time commitments of being an officer and volunteer fit into a full work and personal schedule
• Connect with panelists’ stories to increase interest and confidence in becoming an officer or volunteer
• Understand the benefits of becoming a chapter leader

Content Area: Career development

Target Audience: All levels

Tools and Tips for Tackling Research Manuscript Projects

11/5/2022 11:00 AM - 12:00 PM

Presenter: Monica Nicosia, PhD

For beginning and moderately experienced in-house and freelance medical writers, working on a research manuscript project can be a daunting challenge. Your goal should be to produce a well-written draft that accurately reports the study results and the authors’ interpretation while fulfilling the manuscript preparation instructions for the target journal. What steps should you take to make sure that your work meets or, better yet, exceeds expectations? Best practice topics covered include what resources you might need, how to start, what questions to ask and when to ask them, how to work with difficult authors/clients, and common pitfalls to avoid. While reviewing realistic examples, you will learn tactics and practical tips to help you excel as you tackle these challenging, interesting, and (usually) fulfilling projects. Bring your questions and be ready to share your experiences.

Learning Objectives:

• Outline a stepwise approach for preparing the first draft of a clinical research manuscript.
• Describe tactics to ensure that your draft meets expectations.

Content Area: Scientific publications

Target Audience: All levels

WS #23: Proofreading: Strategy for Document Quality Control

11/5/2022 2:00 PM - 5:00 PM

Presenter: Damiana Chiavolini, PhD

Proofreading is the final—and often underappreciated—step in producing professional documents. This introductory or refresher workshop focuses on proofreading as a strategy for document quality, distinct from writing or copyediting. More than catching typos, proofreading strategies include achieving consistency, sharpening attention to mechanical errors, and identifying and correcting production and layout issues. Standard proofreading practices and electronic proofreading methods are discussed. Participants will learn to train both the mind and the eye to determine what to correct, query, or ignore. In-workshop activities: participants will complete exercises to apply proofreading strategies.

Content Area: Writing/Editing

WS #25: Usage: Choosing the Right Word for the Job

11/5/2022 2:00 PM - 5:00 PM

Presenter: Stephen N. Palmer, PhD, ELS

Designed for moderately experienced medical communicators, this workshop focuses largely on words that are commonly misused in medical writing. We will discuss what is considered correct usage in the academic medical literature (mainly according to AMA style), as well as how to choose words for maximum precision and conciseness. The workshop format includes lecture and group exercises and time for participants to raise questions about usage.

Content Area: Writing/Editing

Calling Activists Against Predatory Publishing—Inspirations from Beall, Cabells and Downes (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Mary Kemper, BS

This session invites networking and brainstorming to further AMWA’s fight against predatory publishing. Cabells estimates that one third of nearly 16,000 predatory journals are medical titles. Librarian Jeffrey Beall coined the term predatory publisher and exposed their fraudulent practices threatening the scholarly literature on his blog scholarlyoa.com. His activism inspired others (eg, nurses tracked predatory journals in their field and independent researcher Mike Downes founded Scholarly Outlaws). Cabells subscription products, including Cabells Medicine launched just this year, feature scholarly analytics of predatory violations and blog posts specific to medical journals. Attendees of this creative session will discuss roles AMWA activists against these academic criminals.

Content Area: Scientific Publications

Target Audience: All Levels

Computer-Aided Regulatory Writing (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Anjana Bose

1Proliferation of Artificial Intelligence in everyday life and advances in technology have renewed interest in its applications in regulatory writing. This discussion will focus on exploring pathways for effective application of new technological tools using a hybrid approach to aid medical writers in preparation of regulatory documents. Participants to share their experiences, vision of computer-aided regulatory writing, and brainstorm opportunities to make the most of new tools in writing high quality documents efficiently.

Content Area: Regulatory Writing

Target Audience: All Levels

Discover What Clients Want (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Heather Gorby, PhD

The client discovery process is a fact-finding mission to learn as much as possible about client needs and goals. This roundtable will focus on how to leverage an assortment of tools, techniques, and best practices to streamline and improve your interactions with potential or existing clients to deliver projects that go above and beyond their initial expectations. Attendees will learn how to glean as much information as possible during the discovery process. This interactive roundtable will provide a customizable list of client discovery questions to help direct your interactions.

Content Area: Other

Target Audience: All Levels

Essentials of Estimands in Clinical Trials (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Cody Nichols, PhD

 In 2019, the FDA published their first addendum to ICH E9 as a way to take steps to address the clinical research community’s concern that the intent to treat population may not always be the best estimation of a medical condition or treatment effect. The resulting guidance focuses on Estimands and sensitivity analysis: which can be powerful and important tools for better prediction of the effects of interest but require thoughtful planning to correctly implement. Through examples and discussion, we will explore the FDA’s suggested framework and best practices for working with teams incorporating these advanced clinical and statistical designs.

Content Area: Regulatory Writing

Target Audience: All Levels

Fact Checking and Annotating for Medical-Legal Review (MLR) (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Melissa Bogen, ELS

Referencing is an integral part of the document development process. Medical writers need to reference every statement containing data or a fact. In addition, they need to mark up (annotate) the reference so fact checkers and reviewers can confirm the document is accurate. This roundtable will explain what's entailed in fact checking and annotating references for MLR, focusing on how editors should check annotations, but also providing guidance on how writers should prepare annotations. Learn best practice guidelines that writers and editors can use.

Content Area: Core Knowledge & Skills

Target Audience: New/Entry Level (0 to 5 years)

Health Podcasting: How to Turn a Print Story into Audio (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Andrea Sonnenberg, JD

Medical writers, with their innate understanding of storytelling, are the perfect podcast producers. Unlike written pieces, podcasting addresses regulatory and educational issues in a format audiences can easily access while performing other activities. Over half of all Americans listen to podcasts-approximately 125 million in 2022. Studies show that podcasts stimulate mental imagery in ways that watching or reading don’t, causing listeners to have to pay more attention and use their imagination. Learn from a working podcast producer how to choose a topic and name, develop an episode format, create cover art, and understand different editing options and platforms for sharing.

Content Area: Wellness

Target Audience: All Levels

How to Use Mendeley for Reference and Bibliography Management (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Diane Morton, MS, MWC

Reference management software has revolutionized scientific writing and bibliography building when reference materials are cited in a manuscript.  This informational roundtable session includes an experiential tutorial for using Mendeley, a free online reference management application. Learn how to import articles, nbib files, notes, and other media to build a database that will help you organize and annotate articles imported for multiple projects.

Content Area: Scientific Publications

Target Audience: All Levels

Innovate to Accelerate (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Robert Panek, PhD

Medical writers are always tasked with completing tasks quickly: how fast can you write a protocol and how long to finalize a clinical study report. Based on real scenarios and methods of how to significantly reduce time and find efficiencies, this round table will discuss what worked. Examples include:

• Lean writing
• Eliminate same information in a table and the text yet still important to describe the numbers in tables in text
• Hyperlinking (Section 4 Ethics)
• Programmed narratives (JMP/SAS)
• CSR shells lockdown
• Multiple writers for critical timeline documents
• QC software (PerfectIt)
• PleaseReview (review/comment collation)
• Bibliographic software for reference management (e.g. ENDNOTE)

Content Area: Regulatory Writing

Target Audience: All Levels

Plain Language Summaries and Beyond: Tips and Tricks for Improving Outreach and Engagement (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Sara Musetti Jenkins, PhD

Plain language summaries (PLSs) are valuable tools for increasing the accessibility of scientific research and boosting engagement with publications. Despite their usefulness, PLSs are still relatively novel, and writers often do not have experience preparing these texts. This roundtable will provide best practices for PLSs, help writers to identify target audiences, and discuss strategies for effective communication. Tips and tricks for developing strong infographics to enhance PLSs will also be covered. By the end of this roundtable, writers will be more confident in their ability to prepare PLSs and advocate for their use in scholarly publications.

Content Area: Health Communication

Target Audience: All Levels

Professionalism Tips for Success in a Changing Work Environment (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Kimberly Mankiewicz, PhD, ELS

It takes more than technical skill to be valuable in the workplace. Often, it is the intangible soft skills that are why we are remembered. With today’s changing workplace norms, as well as mixed virtual and in-person working environments, professionalism and soft skills are more important than ever. We will talk about professionalism techniques for making the greatest impact when writing and speaking in a changing work environment. We will also talk about tips for making a great impression (or redo a negative impression) so you are remembered for the right reasons.

Content Area: Career Development

Target Audience: All Levels

Scaling Up Medical Writing Operations (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Jeanette Towles, MA

Demand for medical writing has increased in recent years. Whether you are a freelancer, a business owner, or medical writing department head, meeting this burgeoning need requires the ability to think past what you are today to what you want to be. This roundtable will offer an opportunity to share thoughts on and best practices for scaling up as well as any pitfalls experienced while doing so. In addition, participants may ask questions or share barriers encountered while trying to expand their medical writing groups to devise a path for growth without sacrificing the quality or consistency of our work.

Content Area: Leadership/Management

Target Audience: Mid-Career (5 to 8 years)

The Art of Developing People Managers (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Kim Jochman, PhD, RAC

Strong medical writers frequently rise through the ranks and wind up managing other medical writers. These new managers have a solid medical writing skillset, but their success as a people manager will hinge upon different skills, such as helping to develop their direct reports’ career, advocating for their direct reports, and assigning appropriate work that challenges direct reports while setting them up to succeed. A shift in mindset from focusing on their own accomplishments to supporting others’ accomplishments also must be achieved. This participatory roundtable will explore methods that attendees use to help managers acquire these new skills and mindsets.

Content Area: Leadership/Management

Target Audience: Advanced (more than 8 years)

Transitioning from Freelance Medical Writing to Retirement (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Barbara T. Zimmerman, B.A., M.A., Ph.D.

This proposal is appropriate for experienced freelance medical writers who have reached an age where retirement is a consideration. This roundtable will enable participants to prepare for an active retirement in which they feel productive and fulfilled, even if a paycheck is not the driving force. A career in freelance medical writing and communication provides skills that can translate into meaningful volunteer work. I wish to share my experiences with this transition to assist participants to prepare for fulfilling retirement opportunities.

Content Area: Career Development

Target Audience: Advanced (more than 8 years)

Understanding the Ripple Effect – Acknowledging What You Really Bring to the Table (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Gretchen Griffin

Merriam Webster defines the ripple effect as “a spreading; pervasive, and usually unintentional effect or influence.” Self-awareness and the ability to “read the room” can help you to build an effective team, have crucial conversations, generate trust and commitment, and provide/contribute to a psychological safe space. Knowing what we, individually and collectively, bring to work and to our teams is critical for successful interactions and relationship building. This roundtable will explore topics like the ripple effect, emotional intelligence, and how they are connected to the evolving work environment.

Content Area: Career Development

Target Audience: All Levels

WFH Goals- Health and Business Planning for Freelancers (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Reggie Wilson

Whether you started working from home out of convenience or necessity, most freelancers base the early part of their careers on the question, “How can I make this work?”  However, after taking on too many responsibilities and missing too much quality time, the question becomes, “How do I want my business to fit into my life?” In this goal-setting roundtable, we’ll learn what the healthy, fulfilling life of your dreams looks like, then pick weekly action steps to build it. Give yourself the structure to build a lifestyle that is energizing, fulfilling, and as productive as you’d like!

Content Area: Wellness

Target Audience: All Levels

When Disaster Strikes! (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Jason Casavant, JD

Teams face more stressors as the regulatory writing environment becomes more dynamic, timelines become shorter, and slight project shifts have disproportionate impacts. Regulatory writers often find themselves at the center of the resulting chaos, processing information quickly and navigating complex relationships, all while delivering on-time, on-budget, and of quality. This roundtable will offer an opportunity to share thoughts on understanding and managing one’s own emotional response while using emotional intelligence to influence how others respond to high-stress situations. Participants will be encouraged to exchange strategies about how to maintain professional decorum, collaboration, and goal-orientedness during stressful times.

Content Area: Leadership/Management

Target Audience: Mid-Career (5 to 8 years)

Your Most Important Earnings Measure: The Effective Hourly Rate (Fri)

11/4/2022 7:30 AM - 8:45 AM

Presenter: Laura Ninger, ELS

Although tracking your hours for each project is tedious, it is the only way to calculate your most important business statistic: how much you really earned, or your effective hourly rate (EHR). You know your EHR with hourly rates because you set it in advance and track your hours to determine billing. If you use project rates, however, you must track hours to determine your EHR in retrospect. Using hypothetical data, we will discuss how to calculate your EHR for individual clients and how to analyze this pricing information to correct your missteps, improve profitability, and set new goals.

Content Area: Career Development

Target Audience: All Levels

Advisory Boards: A Deep Dive (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Cindy van Dijk, BS, MA

Unmet medical needs, discernment on technical aspects of product development, strategic marketing and value assessment are insights biopharmaceutical developers want to glean from leading experts. Advisory Boards bring together key opinion leaders, sometimes from the US and sometimes from around the world to share thoughts and opinions on bringing the next generation agents to fruition. The medical writer plays a key role as the "fly on the wall" capturing ideas and creating concise summary reports upon which companies use to fulfill their objectives. This session profiles, the good, the bad, and the best of working in the Advisory Board world.

Content Area: Core Knowledge & Skills

Target Audience: All Levels

Claiming Your Value: Pricing Strategies for Freelancers (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Abigale Miller, MSc

Are you paralyzed by the idea of talking about money?  It can be difficult for freelancers to know how to estimate project fees and how to choose an hourly rate. This discussion will focus on strategies for how to select an hourly rate, how to estimate project-based fees, and how to communicate with clients about rates. The session will also touch on how and when to increase fees, and how to justify this increase if asked. Participants will finish the session feeling more confident that the fees they are charging are fair to both the client and to themselves.

Content Area: Career Development

Target Audience: New/Entry Level (0 to 5 years)

Connect Over Coffee About Working Remotely (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Liz Proper

You went into medical writing to help people. Now you work remotely and connections you once had seem disjointed and disconnected. Maybe your writing community is scattered across the country. Maybe it’s harder to see how your content helps others. Maybe from afar you’re struggling to build relationships with co-workers.     Roundtable with other remote workers and national award-winning Mayo Clinic managing editors who’ve been navigating telework for years. We’ll share tips and tricks to help us connect better with our peers. Let’s come together to talk about how we can continue to fill others’ cups while maintaining our own.

Content Area: Career Development

Target Audience: All Levels

Essentials of Estimands in Clinical Trials (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Cody Nichols, PhD

In 2019, the FDA published their first addendum to ICH E9 as a way to take steps to address the clinical research community’s concern that the intent to treat population may not always be the best estimation of a medical condition or treatment effect. The resulting guidance focuses on Estimands and sensitivity analysis: which can be powerful and important tools for better prediction of the effects of interest but require thoughtful planning to correctly implement. Through examples and discussion, we will explore the FDA’s suggested framework and best practices for working with teams incorporating these advanced clinical and statistical designs.

Content Area: Regulatory Writing

Target Audience: All Levels

Health Podcasting: How to Turn a Print Story into Audio (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Andrea Sonnenberg, JD

Medical writers, with their innate understanding of storytelling, are the perfect podcast producers. Unlike written pieces, podcasting addresses regulatory and educational issues in a format audiences can easily access while performing other activities. Over half of all Americans listen to podcasts-approximately 125 million in 2022. Studies show that podcasts stimulate mental imagery in ways that watching or reading don’t, causing listeners to have to pay more attention and use their imagination. Learn from a working podcast producer how to choose a topic and name, develop an episode format, create cover art, and understand different editing options and platforms for sharing.

Content Area: Wellness

Target Audience: All Levels

Identifying and Managing Burnout in Medical Writing (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Stephen Carlson, PhD

Burnout is a common occurrence in the modern work environment and can be particularly prevalent in the field of medical writing. Discussion at this roundtable will first focus on understanding burnout. Topics will include common signs and diagnostic criteria of burnout and predictors of future burnout. The discussion will then explore methods for both the management and prevention of burnout.

Content Area: Wellness

Target Audience: All Levels

Job Hazards at a Writer's Desk: Tips to Reduce Health Risks (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Diane Morton, MS, MWC

Writers and editors spend hours doing exactly what we forbid our kids to do: sit in the same position for hours staring at a screen. Even though our career choices require extended sedentary time in front of a monitor, we have learned from experience and from observation that preventive measures can relieve or reduce the physical hazards of the position. Come prepared to learn and share tips to thrive as a writer or editor while considering vision, hearing, dental, postural, stress, and other physical and emotional risks to your health. (This information is not intended to replace your doctor’s recommendations.)

Content Area: Wellness

Target Audience: All levels

Preparing a Scientific Publication Based on a Clinical Study Report: Key Strategies and Challenges (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Andrea Clark, PhD

Preparing a manuscript for publication in a peer-reviewed journal based on a clinical study report (CSR) can be a challenging task for a medical writer. The extensive results presented in the CSR must be condensed into a concise manuscript that reads more as a narrative summary. This discussion will focus on the differences between regulatory writing and writing for scientific publications along with key strategies and challenges in writing a manuscript for peer review based on a CSR.

Content Area: Scientific Publications

Target Audience: All Levels

Pros and Cons of Forming Critique Groups for Medical Writers (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Don Harting, MA, MS, ELS, CHCP

Science fiction writers often form their own critique groups. So do horror writers, romance writers, mystery writers, children’s book writers, and screen writers. So . . . . why not medical writers? Critique groups have been used for many years by writers at all levels of experience who wish to hone their craft, and thanks to the Internet it is easier than ever to set up a group online. But for some reason, critique groups do not seem to have caught on among medical writers. During this roundtable we will gather to share our perspectives on the pros and cons of creating online critique groups for medical writers.

Content Area: Core Knowledge & Skills

Target Audience: All Levels

Scaling Up Medical Writing Operations (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Jeanette Towles, MA

Demand for medical writing has increased in recent years. Whether you are a freelancer, a business owner, or medical writing department head, meeting this burgeoning need requires the ability to think past what you are today to what you want to be. This roundtable will offer an opportunity to share thoughts on and best practices for scaling up as well as any pitfalls experienced while doing so. In addition, participants may ask questions or share barriers encountered while trying to expand their medical writing groups to devise a path for growth without sacrificing the quality or consistency of our work.

Content Area: Leadership/Management

Target Audience: Mid-Career (5 to 8 years)

Technology Disruptions in Medical Writing: How will Content Reuse and Automated Content Generation Affect our Industry (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Heather Graham

 With the introduction of automation technology and content reuse, the regulatory medical writing industry is in the midst of disruption. This disruption has caused writers to reflect on the future of our role in regulatory content creation – will we all be replaced by computers?  The focus of this session will be to speak to the current state of technology use in regulatory content creation and explore how our roles will change as these solutions become further embedded across the industry.

Content Area: Regulatory Writing

Target Audience: All Levels

The Value of Medical Writers: Using the 2021 Survey Results to Empower (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Julia Forjanic Klapproth, PhD

This roundtable will use the 2 AMWA survey articles about the value of medical writers published in 2021 as a basis for discussion to inform and generate ideas about how these results can be used to empower medical writers to produce better documents. By understanding these data, the medical writing community has strong tools to explain to wayward teams why suggestions for good writing processes are valid: we now have direct feedback from the authorities and the community showing this is what they want and acknowledging how these make for better documents that are easier to review.

Content Area: Regulatory Writing

Target Audience: All Levels

Transitioning to Medical Writing from a Clinical Background (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Morgan Leafe, MD, MHA

This roundtable (which sold out twice at the AMWA-DV conference!) will discuss fields in medical writing, how to utilize clinical experience to land a medical writing job, tools (books, websites, courses) to build skills and connections, and tips on navigating your medical writing job search.

Content Area: Career Development

Target Audience: New/Entry Level (0 to 5 years)

Veterinarians: Career Progression from Clinical Practice to Medical Writing (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Christine Iliff, DVM, MS

 Communication is an innate part of both publishing and medicine. Veterinarians and other medical professionals find themselves increasingly involved as primary practitioners, consultants, and authors, in each case using the written word to increase public understanding of disease treatment and prevention. Four medical writing team members (writing, editing, and management) from the veterinary medical community with diverse experiences will discuss shared goals in medical writing and human and veterinary clinical medicine, along with ways to leverage the unique experiences of team members.

Content Area: Career Development

Target Audience: All Levels

What a New Medical Writer Should Know to Excel in a Cross-Functional Team Environment (Sat)

11/5/2022 7:30 AM - 8:45 AM

Presenter: Swati Dadhich-Mandel, PhD

Writing is only one aspect of a medical writer's job. While having a good understanding of the scientific/medical knowledge and strategies of the program is essential, the MW must rely on soft skills and the expertise of other contributors to excel in a cross-functional environment. team. The MW must be a good communicator and collaborator, and should be willing to lead the team as the occasion arises and see to it that all parties pull together to meet and maximize project goals. We will discuss the strategies to excel in a cross-functional team environment in this roundtable.

Content Area: Regulatory Writing

Target Audience: New/Entry Level (0 to 5 years)