Conference Roundtable Discussions

Roundtable discussions offer an opportunity for the sharing of expertise and exchange of ideas in a small-group setting (one leader and up to nine participants). Search the list below to find a relevant roundtable discussion. More information can be found in the registration brochure. Additional fees apply for roundtable registrations.

Roundtable schedule last updated: August 1, 2019.


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Friday, November 8, 7:15 – 8:45 AM
Breakfast Roundtable Discussions

Titles with an asterisk (*) are also offered as a Lunch Roundtable Discussion on Saturday (see Saturday’s list for details).

 

All Aboard the MentorShip: Effective Mentoring in Medical Writing: Mentor Perspective, Elise Eller, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

How do you develop medical writing talent and help medical writers grow professionally? Mentoring can help medical writers at several levels: new to medical writing, new to a company, and new to a specific skill or document type. At this roundtable, we will discuss different strategies for mentoring medical writers at different levels of experience, including internship programs, new hire buddies, and writing partners, and how to provide value to the mentoring experience. This roundtable discussion will focus on the mentor’s perspective. A similar roundtable from the mentee’s perspective is offered as a Saturday lunch roundtable discussion.

 

Art of Writing Accredited and Nonaccredited Continuing Medical Education (CME), Katherine Molnar-Kimber, PhD, President, KMK Consulting Services of Kimnar Group LLC

Transitioning scientists and health care professionals can use their skills for writing continuing medical education (CME). This discussion on accredited CME describes several important agencies, societies, and free resources. Writers of accredited CME often deliver needs assessments, conference programs, webinars, monographs, and cases. Learn about the common 10 elements in grant proposals, Bloom’s hierarchy of verbs, writing learning objectives, meeting National Quality Strategies, and proposing outcome measures. This interactive roundtable (bring nonconfidential questions and samples) will provide an opportunity to discuss several finer details of writing two project types.

 

Avoiding Rejection: Tips for Manuscript Writing Success, Andrea R. Gwosdow, PhD, President, Gwosdow Associates Science Consultants, LLC

Writing manuscripts can be challenging. This roundtable discussion will focus on the primary reasons manuscripts are rejected from journals and how to improve one’s chance of success when preparing manuscripts for publication. Learn practical tips for writing each section of a journal manuscript effectively and efficiently, helping to ensure acceptance. Strategies for dealing with manuscript reviews and responding to reviewers’ comments will also be discussed. Participants will be asked to share their experiences and tips for manuscript writing and publication.

 

Being Informed in the 21st Century, Larry Lynam, Principal, The Lynam Group

The advantage of medical science communication in the 21st century is also sometimes its disadvantage. There are so many ways to source our information and then we have to be concerned—is it information or is it infomercial? How can we tell? At this roundtable discussion, we will share our experiences and discuss platforms and services that work for us, with a goal of extending our conversation to our peers through an Engage post, a future poster conference, or an AMWA Journal article.

 

Benefits of Dynamic Product Information Delivery for Life Sciences, Elizabeth Fraley, CEO, Single-Sourcing Solutions

Dynamic product information authoring and delivery systems have well-documented benefits for medical device and life sciences companies. Documentation produced with these XML-based publishing systems can offer guarantees that your documents pass an FDA audit, while still saving time and money and speeding your product to multiple markets. You can achieve vast savings, reductions in cycle time, and improvements, if you take an intelligent approach, build your vision, and are passionate about using such systems. Join this roundtable discussion to ask burning questions, share your own experience, and hear real accounts of companies who have used XML-based publishing systems for a very long time and learn what they have achieved and whether they saw the return on investment they expected.

 

Certification of Editors in the Life Sciences, Norman Grossblatt, ELS(D), Editor

This roundtable will discuss the meaning, purpose, and value of credentials, particularly those offered by the Board of Editors in the Life Sciences (BELS). It will also cover the history of BELS and information on how to obtain the credentials that it offers.

 

CSR Section 13 or: How I Learned to Stop Worrying and Love Writing the Discussion Section, Trisha L. Houser, Manager, Houser Clinical Research Writing and Consulting, LLC

Going from the more concrete, cut-and-dried sections (eg, Methodology, Results) of a regulatory document to the Discussion/Conclusions section (for clinical study reports, ICH E3 Section 13) can feel daunting. Sometimes, these sections are written by a subject matter expert, but if the responsibility falls to you, what do you write? In addition, what are you looking for as a quality control reviewer? Join this roundtable discussion to address what should be covered in a discussion as well as what might be best presented elsewhere (or not at all). Although there is no one right way to write a discussion, having a better sense of appropriate content can help change that sinking feeling in your stomach to one of excitement; this is your chance to really spread your wings and give meaning and context to all the data you have just reported.

 

*CTD Structure: From IND to NDA, Michael G. Baker, PhD, President & Principal, Samorn Biosciences

This roundtable discussion will provide a summary of the modular structure of the Common Technical Document (CTD) and explain how the CTD evolves and is built through New Drug Application (NDA)/Biologics License Application (BLA) submission and beyond. Topics include typical drug development timelines and costs; the role of the CTD in drug development; the origin, purpose, and structure of the CTD; and the evolution of the CTD from IND to NDA.

 

Don’t You Forget It! Using an Editorial Project Checklist, Laura J. Ninger, ELS, President, Ninger Medical Communications, LLC

The typical freelance has multiple clients, all with different project specifications. Having to change focus with each new project can have a “reinventing the wheel” aspect, even when it’s a repeat client. Learn how to use a customized editing checklist for new or repeat clients in order to clarify new job duties or get back up to speed quickly on familiar projects. Such a checklist includes housekeeping items (eg, contact people, due date), job summary (eg, editing or writing tasks), style sheet sources (eg, journal instructions, client style sheets), and a to-do list that includes multiple cross-checking tasks (for data, graphics, references, use of abbreviations, etc).

 

The Elusive Pursuit of Work/Life Balance, Anita Misra-Press, PhD, Independent Medical Writer

As medical writers, we sit for hours at end writing about diseases, risk factors, and dire outcomes. Between work and family, we are often running ragged, working way past midnight, and never making it to the gym, leading to stress and anxiety as well as a struggle to find time for our own peace of mind. This roundtable discussion will engage all participants in identifying unhealthy habits and addressing effective ways to integrate wellness, balance, and mindfulness without compromising the integrity of our work ethic and our life roles as parents, spouses, pet owners, homeowners, and friends. Join a discussion on realistic and intentional ways to ‘spark joy’ and bring wellness into our everyday lives.

 

Finding the Wild Side: An Introduction to Using Wildcard Find and Replace in Microsoft Word, Kate McKiernan, Freelance Editor

Find and replace is already one of a medical writer’s best friends. But did you ever wish it could be more abstract? Need to check for paragraphs that do not end in a period, or to rearrange all date formatting? You’re in luck: Word already can do this and more from the find/replace menu with the wildcard find and replace option. Wildcards act as a kind of “algebra” that allows searching for patterns rather than exact text alone. This roundtable discussion will introduce key commands that control search patterns, demonstrate how these elements come together in some useful examples, and show how wildcard searches can be combined with other advanced search options to speed up your work while increasing accuracy and consistency.

 

Freelance's Guide to Cybersecurity, J. Kelly Byram, MS, MBA, ELS, CEO/Medical and Scientific Communications Lead, Duke City Consulting, LLC

For freelances and small business owners, data protection can be something that is not thought about until tragedy strikes: a new hard drive fails, viruses and malware attack, or data are taken for ransom. Any of these events can be heartbreaking when personal data are lost or destroyed—eg, emails and photos—but the loss, destruction, or theft of data can be devastating for a business managing ongoing projects and clients’ confidential data. Discuss the universe of potential problems, learn the basics of data protection, and share best practices for securing data without breaking the bank.

 

*From Benchtop to Laptop: Streamlining the Transition to Full-Time Regulatory Writing, Cody Nichols, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

You’ve decided to enter the exciting and boundless field of medical writing. Great! Now what? Whether you are transitioning from the bench in academia, the pharmaceutical sector, or another world entirely, this roundtable discussion is for you. As a growing and developing medical writer, you may have the opportunity to work on a wide range of projects, each with its own unique challenges. Discussion topics will include various types of documents in medical writing and where to gain valuable training and experience needed for each; some tips and tools to ease the transition into regulatory medical writing; how to adapt transferable skills to current roles; and the importance of soft skills and resources for perfecting them.

 

Grow Your Own Local Network of Communication Professionals, Joanne M. McAndrews, PhD, Freelance Medical Writer

Online networking (LinkedIn, Twitter, Facebook, AMWA Engage, etc.) is wonderful, but nothing really beats face-to-face interaction with colleagues. Learn the how-tos of starting and maintaining a network of writers, editors, and other communication professionals in your area. Discussion topics will include recruiting members, finding a place to meet, meeting formats, meeting topics, maintaining a membership list, and the many benefits of connecting in person on a regular basis with professionals in your field.

 

*How Did I End up Working Here?, Lisa Carricaburu, MBA, Managing Editor, Decision Support Products/Informatics-Decision Support, ARUP Laboratories

Ever wondered who really writes a hospital system's clinical guidelines? Physician newsletters about an insurance company's medical policies? Government proposals for health care programs? Information on what lab test to order to diagnose a condition? Come learn how you can make inroads into some unexpected arenas by leveraging other types of writing work, management skills, and collaborative teaming experiences—often as part of nonmedical writing roles. Brainstorm ways to build and promote your key competencies in these less-understood medical communication settings.

 

How to Improve Editing and Writing Skills in a Multilingual Environment, Natalia Andrea Abdelnur León, Assistant Clinical Technical Editor, MSD

Are you part of a medical writing team immersed in a multilingual environment? Growing medical writing teams call for rapid adaptation to department-specific style standards to meet submission requirements. In that context, the process demands editing and writing to be carried out in English, even though it may be the second language for some team members. One way to approach the challenges this brings is to have multimedia-assisted language learning materials available, given that as the command of the language becomes better, so does document quality. Topics to be discussed include tips to keep focused when editing to avoid common mistakes, strategies implemented in successful language-learning initiatives, and practices to facilitate communication between nonnative and native English speakers.

 

HTAs and AMCP Dossiers: Find Out What They Are in Five Easy Steps!, Linda Rice, Medical Writing Senior Manager, Amgen Inc.

Have you heard the terms HTA and AMCP dossier but weren't quite sure what they meant? During this roundtable discussion, an overview will be provided to define health technology assessments (HTAs) and Aacademy of Managed Care Pharmacy (AMCP) dossiers, what kind of information these documents contain, what agencies use these documents, and how the development of a payer document (such as an AMCP dossier) compares with writing a scientific publication. A basic understanding of HTAs and AMCP dossiers is useful to medical communicators interested in working on payer-related documents and in learning about how decisions are made regarding drug access/reimbursement in the managed-health care setting. Come learn about the brave new world of writing payer-related documents!

 

I Have the Abstract: How Do I Make It into a Poster?, Michelle E. Stofa, Research Communications Manager, Nemours/Alfred I. duPont Hospital for Children

To effectively promote and communicate results of research presented at a meeting, a poster must be organized in a clear, easy-to-read, and attractive format. This roundtable discussion will address how to develop a poster from an abstract from first acceptance (what you ‘need to know before you go’) and will include tips about text, figures, color, and overall layout to create a well-organized and attractive presentation for posters in both printed and electronic format. Also offered will be several short-cuts in creating a poster that allow the presenter to manipulate the components more easily. Before-and-after examples will be shown to illustrate important points.

 

It’s Been X Years, Now What Do I Do?, Mari Welke, Director US Operations, Trilogy Writing & Consulting

This roundtable discussion focuses on options when you feel like you’ve done it all, you’ve experienced all the documents, or you feel like you’ve become an expert. Explore potential paths forward into areas such as management, consulting, teaching, or others. Share thoughts on how to stay motivated to keep doing the same work or consider other options where experience in medical writing may be beneficial.

 

The Location-Independent Medical Writer: How to See the World while Doing What You Love, Bryce Marquis, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

Do you want to be an expat, digital nomad, slow traveler, or world schooler? Do you even know what these terms mean? This session will explore these location-independent lifestyles while assessing their compatibility with a career in medical writing. We will discuss the following topics: tools designed to help take your trade on the road, the nuts and bolts of working as a medical writer while traveling long-term, and the potential pitfalls that may be encountered when working location-independently. We will also address questions like “How do I choose where to go?”, “How do I afford it?”, “What about taxes?”, and any others you may have as we explore how to make travel part of your everyday life without missing a beat in your career.

 

Managing Cross-Functional Teams, Julia Forjanic Klapproth, PhD, President and Senior Partner, Trilogy Writing & Consulting

Writers on submissions work with individuals from different functions and departments. Although it would seem obvious that everyone is working toward a common goal, one often wonders if these individuals are all on the same team! The writer’s job is to cull the necessary information and messages from these functions and prepare a document with a unified message. It frequently falls to the medical writer to mediate and help find agreement on what needs to be communicated. Learn some survival techniques for handling these teams, and share your experience with the challenges of cross-functional submission teams and discuss techniques for successfully managing them.

 

Medical Writer Burnout: How Leadership Plays a Vital Role, Lori Regis, MS, Senior Manager, Medical Writing, PRA Health Sciences

Work-related stress or burnout is something many employees experience at one time or another. It is crucial for leaders to recognize the signs of burnout to prevent employees from reaching a breaking point. This roundtable discussion will focus on steps leaders can take to foster a healthy workplace, such as improving communication encouraging teamwork, focusing on employees’ strengths, connecting to purpose, and accepting accountability.

 

A Medical Writer’s Guide to Single- and Multiple-Ascending Dose-Escalation Combination Studies, Shawn Watson, PharmD, PhD, BCPS, Associate Director, Clinical Sciences, Vertex Pharmaceuticals

Although single-ascending dose-escalation (SAD) and multiple-ascending dose-escalation (MAD) studies can be done sequentially, combining them into the same protocol and running cohorts concurrently can be done safely and accelerate overall clinical development. Both SAD and MAD studies require intensive safety monitoring and typically involve evaluation of pharmacokinetic assessments. Come learn about SAD and MAD studies, including what information these studies provide, the rationale for combining SAD and MAD studies into a single protocol, strategic considerations for combining these studies, and tactical guidance for writing these combined study protocols.

 

Medical Writing in Marketing and Communications, Valerie Sjoberg, MAc, MWC, Medical Writer, MJH Life Sciences; Owner, BioWrite LLC

This roundtable discussion will address the need for medical writers in health care marketing and communications, and describe typical clients/employers, types of content produced, career and salary outlook, and skills needed to succeed in this setting.

 

Nonclinical Recall: The Total Reality of Writing CTD Sections 2.4 and 2.6, Rochelle Mills, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

Nonclinical investigation is an indispensable step in drug development. Sections 2.4 and 2.6 within Module 2 of the Common Technical Document (CTD) describe the nonclinical pharmacologic (actions of a drug on a biologic system), pharmacokinetic (effects of a biologic system on a drug), and toxicologic (safety) evaluations of the intended marketed pharmaceutical. The study reports that serve as sources for Sections 2.4 and 2.6 can be thousands of pages long and are often written by diverse contractors. Join this roundtable discussion to learn about the types of nonclinical studies that contribute to small molecule versus biologic programs, the content of nonclinical CTD sections as directed by guidelines, and writing strategies for condensing preclinical study reports for Module 2. A detailed handout will be provided.

 

Pricing Strategies for Freelances, Heather Gorby, Freelance Medical Writer, Gorby Consulting

Many factors should be considered when determining what to charge for a given project, and the more information the writer has about the final deliverable, the better he or she is able to estimate the time involved. This roundtable discussion focuses on strategies for pricing individual projects across all types of medical writing or editing. A discussion of the major parameters to consider when determining costs will help participants develop a strategy for creating their own pricing guides in their niche markets.

 

Seven Habits of Highly Successful Medical Writers, Kimberly Newton, Senior Director, Medical Writing, Veristat, LLC

Developing into an experienced, skilled medical writer requires an investment of time writing a variety of both simple and complex documents, and an understanding of the concepts, regulations, guidelines, and policies in your particular medical writing setting. In addition to all this knowledge and writing experience, though, the most effective medical writers consistently demonstrate seven habits that establish them as highly successful writers who inspire confidence in their working teams and with their clients. These habits are universal across medical writing settings but will be discussed within the context of the pharmaceutical/biotech industry.

 

Simplify the Document Review Process and Get Your Life Back!, Kristi Boehm, MS, ELS, Manager, Medical Writing, Lexicon Pharmaceuticals, Inc.

The process of document review has undergone a transformation in recent years. Facilitating review cycles typically falls on the Medical Communicator. While there are many different types of document review processes and software programs available, there are pros and cons to each. Current processes may involve group emails, cloud-based reviews, virtual meeting rooms, electronic document management systems (eg, electronic file cabinets), and collaborative review software. This presentation will give insight into each option and discuss how implementing a structured review process can reduce the burden placed upon the Medical Communicator. With over 35 years of Medical Writing experience in large and small pharmaceutical companies, the medical device industry, and academia, the presenter will provide tips for making your document reviews less burdensome and more efficient.

 

*Taking EU Medical Device Teams into the Year 2020, Julie Hurt, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

You’re a skilled, knowledgeable medical writer with a focus on medical devices and compliance with MEDDEV 2.7.1, Rev. 4 and EU Medical Device Regulation (MDR). You’ve helped your client teams interpret the guidance to create compliant clinical evaluation reports (CERs) in this changing regulatory landscape … so, how’s that been working for you? Questions surrounding the updated regulations for EU medical device marketing remain a key topic in industry. As manufacturers enter the final stretch to ensure their CERs and technical files are MDR-compliant by May 2020, what have we learned as a medical writing community to support industry documentation needs? What strategies have been successful for meeting client team and Notified Body needs? Come and share lessons learned from your experience transitioning to MDR-compliance.

 

Tech, Travel, and Data Security, Kathy Boltz, PhD, Owner and Principal, On Point Scientific, LLC

This roundtable discussion focuses on how to keep your data safe at home and on the road. Topics will include file sharing, backup systems, screensharing solutions for remote work, travel apps, and network access on the road to help ease travel frustrations. Also discussed will be ways to protect your identity and data through practices that include encryption and passwords. This roundtable discussion is aimed at those working as individuals and as microbusinesses.

 

Think Like a Grant Reviewer, Madison Hedrick, MA, Senior Medical Writer, Wilson Carroll Research Services, LLC

Grant writing is often solitary work. This roundtable discussion offers an opportunity for grant writers to get together and gain insights on the grant application process. The discussion will focus on such keys to success as how to match a proposal with funding source based on the topic and scope of the project and how to distinguish and develop specific aims, research questions, and hypotheses for qualitative, quantitative, and mixed-methods proposals. Also discussed are current funding mechanisms at the National Institutes for Health (NIH) for researchers, including career award (K) and training mechanisms; and how proposals are reviewed and evaluated at NIH.

 

*Tips for Studying for the MWC Exam, Brian Bass, MWC, President, Bass Global, Inc.

Some medical writers worry about sitting for the Medical Writer Certified (MWC) Examination because they don’t work in all areas of medical communication or are unsure of how best to study for the exam. The Applicant and Candidate Handbook and Study Guide developed by the Medical Writing Certification Commission (MWCC) are essential tools for anyone thinking of sitting for the MWC exam. Learn about these tools and how to best prepare for the exam, regardless of your medical communication background.

 

Transitioning from Freelance Medical Writing to Retirement, Barbara T. Zimmerman, PhD, Owner/Manager, Biomedical Communication & Consulting

You are a freelance medical writer and have been working in the field for at least 5 years. You have now reached an age where retirement is possible or even desirable. The reasons people retire and when they retire are varied. Some look forward to putting their career in the past and focusing on a life of leisure. However, many retirees wish to continue to feel productive and fulfilled, even if a paycheck is not the driving force. A career in medical communication can lead to this outcome in retirement. This roundtable discussion will provide some suggestions on how to prepare for an active retirement while finding opportunities that are suitable and fulfilling and that tap into your vast array of skills and talents.

 

Translators Networking, Matthew Mckeehan, MA, ELS, Translator, Chugai Pharmaceutical Co., Ltd.

This roundtable discussion is an opportunity for medical translators to discuss industry trends and translation technologies, share stories and creative solutions, and form connections and friendships—in short, to network! Any language combination and all levels of experience are welcome. Planned discussion topics include machine translation, terminology management, addressing client expectations, and computer-assisted translation, and participants are invited to raise specific topics of interest for discussion.

 

Use It, Don’t Lose It: Strategies for Better Time Management, Melissa Christianson, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

Time is a writer’s most valuable resource, and managing this resource in the face of competing challenges can be a complex task. However, most writers receive little if any training on effective time management and, consequently, lose a sizable fraction of their available working time to inefficiency, distractions, and other productivity pitfalls. Fortunately, making just a few small changes in how we work can help to halt this process. In this roundtable discussion, we will identify some of the most common (and detrimental!) challenges in time management and share specific approaches for avoiding these pitfalls in our day-to-day work. Participants will leave the roundtable with actionable strategies for improving their time management skills.

 

Veterinary Medicine Expertise: Challenges and Opportunities in Medical Writing, Suzanne Pratt, MBA, DVM, MS, DAVCP, ELS, Principal, Suzanne Pratt Works, LLC

In an era of One Health, the connections between human and animal health are ever more clear. Writers with expertise in veterinary medicine bring a breadth of knowledge and perspective that differs substantially from those of writers with a human health perspective. As a minority group in the medical writing field, how do we veterinarians best communicate the value of our knowledge? What parts of our training and experience are similar to and different from others in medical writing? What skills should we hone to be competitive in this field? Should we “niche down” in animal health or expand into human medicine arenas? The challenges and opportunities for medical writers with veterinary medicine expertise will be explored.

 

Women in Medical Writing and Communications: A Discussion of Challenges and Successful Life Hacks, Tara Gupta, PhD, Principal, Medical Writer, 2G Consulting and Services

There is a well-recognized brain drain in the job force for women with STEM degrees. According to a recent AMWA Journal article, women hold a minority of STEM jobs overall (24%), but the majority of AMWA members are women (84%) [Matic AI, Jadhav P. AMWA J. 2018;33:152-156.], suggesting that medical communication careers may offer women better opportunities for participation and success. Women in AMWA may have a unique opportunity to lead the discussion on STEM career development for women as well as promote creative solutions to identified challenges. This roundtable discussion will address both internal and external challenges women face during career development, life hacks and habits we use to navigate work/life balance, and action steps we can take to create networks and opportunities for women at different stages in their careers. The roundtable will form the basis for a future position paper, on which the participants are invited to collaborate and coauthor.

 

Work/Life Integration for Freelances and Full-Time Employees Alike: Staying Balanced while Working Remotely, Jennifer Thayer, Head, Medical Writing and Scientific Communications, BioBridges

Today, many of us work remotely, whether we are freelances or full-time employees. Although many of us love the flexibility that remote working provides, there are risks we all must manage, including the tendency to overwork, constantly check email, and work through what would normally be personal or family time off. At this roundtable discussion, we will discuss some of the ways remote medical communicators can succeed professionally and thrive personally while avoiding burnout, leading to a successful work/life integration. Participants will be invited to share their best practices on the topic.

 

*Writing while Female: A Discussion of Gender Disparity/Bias in the Medical Writing Industry, Stephanie Leveene, ELS, CMPP, Senior Market Access Writer, Evidera

This roundtable discussion provides a welcoming space for participants to discuss their experiences of being women in the medical writing profession. Some potential talking points may include the following: Does bias in academia impel some women to enter the medical writing field? Does a lack of support for working mothers translate into a move out of the full-time workforce and into freelancing? Is gender an impediment for moving into higher positions in the field? Have you experienced gender discrepancies in salaries? (Read “Gender Bias in STEM: How Medical Communicators Can Act,” in the Winter 2018 issue of the AMWA Journal.)

 

Saturday, November 9, 12:00 – 1:30 PM
Lunch Roundtable Discussions

Titles with an asterisk (*) are also offered as a Breakfast Roundtable Discussion on Friday (see Friday’s list for details).

 

All Aboard the MentorShip: Effective Mentoring in Medical Writing: Mentee Perspective, Cody Nichols, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

How do you develop medical writing talent and grow professionally as a medical writer? Mentoring can help medical writers at several levels: new to medical writing, new to a company, and new to a specific skill or document type. At this roundtable, we will discuss different medical writing mentoring strategies, including internship programs, new hire buddies, and writing partners, and how to get the most out of each mentoring experience. This roundtable discussion will focus on the mentee’s perspective. A similar roundtable discussion from the mentor’s perspective is offered as a Friday breakfast roundtable discussion.

 

Basics of Writing Accredited and Nonaccredited Continuing Medical Education (CME), Katherine Molnar-Kimber, PhD, President, KMK Consulting Services of Kimnar Group LLC

Continuing medical education (CME) is a niche often explored by transitioning scientists and health care professionals. This roundtable discussion highlights the similarities and differences between accredited and nonaccredited CME, including their different functions and frequency. Can both types of CME be fair balanced? Free resources, important agencies, and professional societies will be mentioned. Learn about the importance of outcome measures, including questions before and after the educational activity. Obtain tips on writing effective pre-and post-questions. Discuss the niches filled by accredited and nonaccredited CME in updating the professional health care practices of current health care professionals. Bring questions and nonconfidential examples to discuss.

 

Breathing New Life into Work/Life Balance, Stephen Carlson, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

Lack of a healthy work/life balance can lead to professional dissatisfaction and burnout and contribute to the development of negative habits (eg, social isolation) and detrimental health conditions (eg, insomnia, fatigue, substance abuse, irritability). At this roundtable discussion, we will primarily address the benefits of a healthy work/life balance (eg, reduced stress, increased quality time with family) and strategies for how to establish and maintain this balance. Possible topics for discussion include identifying priorities, establishing meaningful measures of quality of life, addressing different attitudes on and methods of multitasking, and allowing for flexibility/adaptability, as well as insights from research and experts in the field.

 

Building Successful Sponsor and Vendor Relationships, Michelle Lee, Manager, Gilead Sciences

Outsourcing is an important component to the business strategy of many pharmaceutical and biotechnology companies. Engage in a thoughtful dialogue and determine how to develop and maintain successful sponsor and vendor relationships. Discussion topics include managing changing timelines and priorities, effective communication, training and onboarding, tools and technology, and value-added metrics.

 

Cross-Cultural Communication Skills as a Key Element for Success, Jennifer Clemens, ELS, Medical Writing Clinical Technical Editor, Global Clinical Trial Operations, Merck & Co., Inc.

Current medical writing activities have expanded worldwide across a wide range of organizations, bringing onboard a rich talent pool from different countries. Developing cross-cultural communication soft skills becomes a key element for medical communicators to expand their skill set toward productive and successful teamwork. Participants will discuss the main communication challenges medical writers and editors face when interacting with colleagues or stakeholders from diverse cultural backgrounds and will learn key elements of effective communication that consider colleagues’ mindsets, cultures, and thoughts.

 

*CTD Structure: From IND to NDA, Susan Vintilla-Friedman, Senior Director, Development, Samorn Biosciences

This roundtable discussion will provide a summary of the modular structure of the Common Technical Document (CTD) and explain how the CTD evolves and is built through New Drug Application (NDA)/Biologics License Application (BLA) submission and beyond. Topics include typical drug development timelines and costs; the role of the CTD in drug development; the origin, purpose, and structure of the CTD; and the evolution of the CTD from IND to NDA.

 

*From Benchtop to Laptop: Streamlining the Transition to Full-Time Regulatory Writing, William Buchta, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

You’ve decided to enter the exciting and boundless field of medical writing. Great! Now what? Whether you are transitioning from the bench in academia, the pharmaceutical sector, or another world entirely, this roundtable discussion is for you. As a growing and developing medical writer, you may have the opportunity to work on a wide range of projects, each with its own unique challenges. Discussion topics will include various types of documents in medical writing and where to gain valuable training and experience needed for each; some tips and tools to ease the transition into regulatory medical writing; how to adapt transferable skills to current roles; and the importance of soft skills and resources for perfecting them.

 

*How Did I End up Working Here?, Kathi Whitman, MA, Project Consultant, SelectHealth

Ever wondered who really writes a hospital system's clinical guidelines? Physician newsletters about an insurance company's medical policies? Government proposals for health care programs? Information on what lab test to order to diagnose a condition? Come learn how you can make inroads into some unexpected arenas by leveraging other types of writing work, management skills, and collaborative teaming experiences—often as part of nonmedical writing roles. Brainstorm ways to build and promote your key competencies in these less-understood medical communication settings.

 

Instructional Design: Are You Considering Learner Usability in Your End Products?, Deborah Anderson, PhD, MS, MT(ASCP)SH, Medical Writer/Instructional Designer, DGA Medical Communications

Instructional design is the 10,000-foot view focus on education. It takes into account the entire program, learners, end deliverables, and everything in between. But what about that everything in between? One main focus that is prevalent in all types of medical education pieces is the learner usability? Do you write for learner usability meaning...are your end deliverables developed in a way that improves the chances that your learners will comprehend what you are trying to say? During this roundtable, we will touch on specific aspects of learner usability, such as affordance, alignment, chunking, color, consistency, proximity, readability, recognition, similarity, and visibility. As we review each of these areas, we will discover how they can play a vital role in enhancing learning materials.

 

Managing Clinical Study Report Development, Jayashree Mitra, PhD, Principal Medical Writer, Merck & Co.

The clinical study report (CSR) is a crucial document for regulatory submission, as it contains all relevant results of a study. The CSR has components that are developed at different times during the process of writing. Therefore, efficient management of these components is important for successful and timely submission. This roundtable discussion will focus on these CSR components and composition; timelines for developing these components; delegation of writers to various components depending on timeline needs; taking the lead in preparing timelines for reviews and review management, quality control, version control; and tips on working with clinical teams and other functions. Participants will be invited share experiences with problems encountered during writing, assembly, and publication of a CSR.

 

New Research Shows Freelance Rates Are Lower for Women. Why, and What Can We Do About It?, Laura J. Ninger, ELS, President, Ninger Medical Communications, LLC

Most women know that they are still not paid the same as men in traditional employment, but 63% of freelances don’t realize that there may be a similar, or even higher, pay gap for female versus male self-employed workers. This roundtable discussion will review statistics on the gender pay gap according to a 2018 workforce study, historical trends on female versus male pay in the United States as a whole, and some reasons why this inequity still exists. Even the 2015 AMWA Salary Survey showed a persistent wage gap for full-time workers, which may also apply to freelances. Learn some strategies for more effective negotiations.

 

SAD or MAD but not Alone: Medical Writing for Small Biopharma Companies, Alex Rohall, Senior Manager, Medical Writing, PROMETRIKA LLC

Are you the first or only medical writer in your ”early-stage” company? You probably understand acronyms like FIH, SAD, and MAD – but does your employer understand the value medical writing adds to clinical development? Come meet and swap stories with other writers for startups and small, early-stage biopharma companies.

 

Scheduling Dos and Don'ts for Freelances, Debby Berylne, Freelance Writer/Editor

Come talk about experiences and tips for achieving a manageable workload, dealing with both slow and heavy workloads, balancing personal and work responsibilities, keeping clients happy when taking vacations and weekends off, managing client expectations about timelines, and other scheduling challenges for freelances. We’ll discuss how to manage our workloads and client expectations when clients can’t (or don’t) tell us exactly what the work will involve or when it will come but still expect us to complete it quickly whenever it does show up. We’ll review ways to respond to the varying needs of several different clients at the same time without making our lives too insane.

 

So, You're Going to Take the BELS Exam, Leslie Neistadt, ELS, Managing Editor, St. Louis University

This roundtable discussion begins with a brief introduction to the Board of Editors in the Life Sciences (BELS) and about how to decide when, in the course of one's career, to take the exam. The discussion will also focus on the format of the exam, how to prepare for it, and tips for exam day. Participants will have sufficient time to ask questions about any aspect of the process.

 

Strategic Publication Planning, Michael G. Baker, PhD, President & Principal, Samorn Biosciences

Publication in peer-reviewed medical journals helps to establish compound awareness by educating health care professionals about in-development or marketed drugs/devices, including new clinical applications or safety information. This roundtable discussion focuses on strategic development and execution of publication plans, an increasingly important platform used by biopharmaceutical companies to ensure that health care professionals are aware of key data on their compounds in development or that are commercial. Topics to be addressed include identification of key publications to support brand strategy, overcoming challenges of working with busy authors, leveraging skill sets of communications agencies and medical writers, appropriately targeting journals and conferences, ensuring timely release of publications, and setting expectations regarding value for dollar, resource utilization, and timelines.

 

Strategies to Structure and Lead Teams through Learning Processes, Catalina Gonzalez Rueda, MSc, MBA, Associate Director, Medical Writing, MSD Colombia

Training and mentoring programs are exceptional opportunities for both individual growth and team development. How can we make sure we design these programs for optimal impact from the beginning? Our role as leaders is to design learning programs that not only impart knowledge but motivate team members to work at a high level of responsibility to enhance interpersonal and leadership skills, encourage feedback, and build effective teams. In this roundtable, we will discuss strategies for making an initial assessment of learning needs and designing the appropriate training and mentoring plans to support learning processes, career development, and group goals. Participants are invited to share experiences with the learning process and find the best approaches to fostering a culture of learning and growth.

 

*Taking EU Medical Device Teams into the Year 2020, Stephanie Knighten, MS, Senior Medical Writer and Associate Manager, Whitsell Innovations, Inc.

You’re a skilled, knowledgeable medical writer with a focus on medical devices and compliance with MEDDEV 2.7.1, Rev. 4 and EU Medical Device Regulation (MDR). You’ve helped your client teams interpret the guidance to create compliant clinical evaluation reports (CERs) in this changing regulatory landscape … so, how’s that been working for you? Questions surrounding the updated regulations for EU medical device marketing remain a key topic in industry. As manufacturers enter the final stretch to ensure their CERs and technical files are MDR-compliant by May 2020, what have we learned as a medical writing community to support industry documentation needs? What strategies have been successful for meeting client team and Notified Body needs? Come and share lessons learned from your experience transitioning to MDR-compliance.

 

A Tale of Two Contemplations: Impostor Syndrome and Medical Writing Dreams, Anand Devasthanam, PhD, Medical Writer II, PAREXEL International Corporation

Participants will engage in a discussion of four core strengthening strategies aimed at learning how to present oneself as a strong candidate for a position in medical writing: (1) self-directed learning through AMWA, (2) seeking lessons learned from successful medical writers, (3) structured outreach, and (4) adding value to the medical writing community. Learn how to navigate and use AMWA resources, what questions are crucial to ask when conducting informational interviews with medical writers, how to gain writing experience through volunteering and outreach, and how to achieve and increase visibility in the medical writing job market.

 

*Tips for Studying for the MWC Exam, Valerie Sjoberg, MAc, MWC, Medical Writer, MJH Life Sciences; Owner, BioWrite LLC

Some medical writers worry about sitting for the Medical Writer Certified (MWC) Examination because they don’t work in all areas of medical communication or are unsure of how best to study for the exam. The Applicant and Candidate Handbook and Study Guide developed by the Medical Writing Certification Commission are essential tools for anyone thinking of sitting for the MWC exam. Learn about these tools and how to best prepare for the exam, regardless of your medical communication background.

 

Working Remotely – I Mean Really Remotely: Tales from Nomadic Living in an RV, Rasa G. Hamilton, ELS, MWC, Medical and Science Editor, HELPS: Hamilton Editing and Language Publishing Services

Inspired by stories of digital nomads, I realized that I too could conduct my freelance business anywhere (even a remote campground in Montana). The dream of travel and adventure prompted me to give away my possessions and trade my large home for a truck and camper. After nearly a year as a digital nomad and with my husband serving as a camp host in parks across the United States, I will share how I combined work and travel, including costs, technologies, and my personal highs and lows of living on the road. Whether you are already a nomad or considering being one, let’s use this roundtable discussion to discover that nomadic life is easier than you think.

 

Writing a Business Plan, Mark D. Weiss, President, Apothaceutics International, Inc.

A business plan for a medical writing business is a key to the survival and growth of the business. Writing a business plan is applicable to those just starting out or transitioning to freelance self-employment as well as to long-time and experienced freelances. The business plan helps answer core questions: (1) What is the business or service? (2) What are your objectives? (3) What are the unique aspects of the business or service? Come learn how a business plan (on paper or in your mind) can help you to start or grow your business, monitor and assess progress towards your goals, and identify and fix problems.

 

*Writing While Female: A Discussion of Gender Disparity/Bias in the Medical Writing Industry, Christine Flees, MD, Senior Medical Writer, Syneos Health

This roundtable discussion provides a welcoming space for participants to discuss their experiences of being women in the medical writing profession. Some potential talking points may include the following: Does bias in academia impel some women to enter the medical writing field? Does a lack of support for working mothers translate into a move out of the full-time workforce and into freelancing? Is gender an impediment for moving into higher positions in the field? Have you experienced gender discrepancies in salaries? (Read “Gender Bias in STEM: How Medical Communicators Can Act,” in the Winter 2018 issue of the AMWA Journal.)

 

 

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