Regulatory medical writers are key personnel in delivering quality regulatory documents that advance science and medicine, keeping patients safe and informed about the benefits and risks of pharmaceutical products.
Regulatory writing is an important and challenging medical writing specialty. AMWA’s Value of Medical Writing Workgroup identified quality, timelines, and interactions with stakeholders as common barriers to success.
AMWA’s Measures of Success Toolkit is a collection of resources that explores the regulatory writing environment, offering expert advice on achieving quality, managing timelines, and handling interactions with stakeholders.
Freelance medical writers provide valuable expertise and experience and therefore need to be compensated appropriately. One of the perennial questions for freelancers is how much to charge clients for services.
Luckily, we don’t have to reinvent the wheel. Many resources and experts are available to help freelancers determine value-based pricing for their services.
Artificial intelligence (AI) and the subcategory machine learning (ML) are evolving quickly, and regulators around the world are working to respond to new opportunities while mitigating potential risks involving the technology.
With so much digital content vying for our attention, medical communicators need to harness the power of visual communication. Otherwise, high-quality health care messaging could end up buried in a sea of social media reels and misleading posts.
Today’s medical communicators have access to tools for creating engaging visual content. Visual elements such as graphs, maps, infographics, and images can keep health care content visible to target audiences while elevating health care communication in significant ways.
If artificial intelligence (AI) can read diagnostic tests, identify cancer cells, and construct cohorts for clinical trials, can it write medical journal articles and create regulatory documents? In other words, can AI be a medical writer?
No, it cannot. Primarily because most major medical journals reserve the task of authorship for humans because AI is a tool to augment, not substitute for, human intelligence.
This is not to say that AI can’t be helpful in medical writing. AI is a promising technology transforming entire industries, and medical communication is no exception. Generative AI, such as generative pre-trained transformers (GPTs) and chatbots, can be harnessed to enhance the efficiency of medical writers while connecting us to the vast storehouses of knowledge that exist.
It is possible to use AI’s tools responsibly and ethically in the service of medicine and science.
Are you looking for a career pivot from the world of research to medical writing?
Many of the skills you already possess as a nonclinical or biomedical researcher are essential to advance in the growing field of medical communication.
What does it take to make the move into this ever-changing and rewarding career?
Language is powerful and can be used to illuminate, explain, heal, hurt, include, or exclude.
The English language is evolving constantly, and medical communicators need to stay abreast of best practices. Inclusive language is one way that medical communicators can avoid bias and create a respectful climate for all people.
To succeed as a medical communicator, writers and editors must master essential technical skills such as grammar, medical terminology, and statistics. However, medical communicators who excel offer more than technical expertise.
Health is much more than numbers, medications, or a clinical diagnosis. A person’s health is affected by their environment and their lived experiences.
Welcome to the busy life of a medical communicator. Medical writers and editors are busy professionals who juggle multiple projects, teams, and tasks.
Medical writers make scientific information accessible for readers and empower people to make informed decisions about their health.
Health care or medical public relations (PR) is a growing niche for medical communicators that involves translating and sharing complex medical information with a general audience of patients and consumers.
Public relations professionals—both freelance and those employed by companies—play important roles by sharing news of medical discoveries, promoting products, and educating consumers.
Clinical consensus statements and clinical practice guidelines are among the documents used to ensure that patients are receiving the best care possible and that clinical decisions reflect the opinions of the experts who are invested in excellent clinical outcomes.
In other words, consensus statements are created when experts provide guidance for medical issues, even when the evidence is still being gathered, whereas clinical practice guidelines are developed based on high-level evidence.
Before a medical device is marketed to the public, it needs to undergo a rigorous analysis to ensure that it is safe and effective.
Devices sold in the European Union need to meet the standards published by the International Medical Device Regulators Forum (IMDRF), a group of regulators from around the world.
All medical communicators need to adhere to a strong set of ethics and standards. In particular, regulatory medical writers who collaborate on company‑sponsored biomedical research projects are part of a chain of responsibility for accurately reporting the results of clinical trials.
Most successful freelance medical communicators seek a steady stream of work by cultivating a roster of trusted repeat clients.
It is a mutually beneficial arrangement. When clients find a reliable freelancer who knows their business and produces high-quality work, they'll stick with them.
This article was written by Bill Ostrem, PhD, and is based on content presented by Abbie Miller, MWC, at the AMWA Medical Writing & Communication Conference. Additional session reports are available in the AMWA Journal.
Today's communication and media landscape offers medical writers a multitude of venues or "channels" for their writing. How do you as a medical writer choose an appropriate channel for a given purpose? And how do you tailor your message for that channel?
Every document improves with editing, and medical editors are key to the process of creating consistent, readable, and error-free manuscripts.
What are the fundamentals of manuscript editing for medical communicators? What are editors looking for when they edit manuscripts? What tools are available when editors seek to create high-quality manuscripts?
Open access (OA) publishing is a model of publishing that mainly shifts the costs of publishing an article from the reader to the authors and distributes scholarly works online without paywalls or other barriers.
The concept of open access is part of a larger movement called Open Science that seeks to make scientific documents, data, and research more accessible and equitable.
Medical communicators are key collaborators in a scientific ecosystem where critical research findings and discoveries move from laboratories to the wider world, improving the health and lives of patients and communities.
As the fields of medicine and health care advance, the demand for medical writers increases.
AMWA acknowledges the contributions of Crystal Herron PHD, ELS, as lead content developer, and Michelle Sauer Gehring PHD, ELS, for peer review, in the development of this AMWA resource.
As the world moves in a more interconnected, digital, and collaborative direction, best practices in authorship have become less straightforward.
Medical writers may find themselves contributing to manuscripts in many ways and might encounter problematic examples of ghost authorship, gift authorship, and guest authorship.
Why should you track your time as a freelancer?
Freelance medical writers and editors are often juggling multiple projects for multiple clients. Whether you are getting paid per project or per hour, tracking the time you spend on each client’s work is essential for making sure you and the client are meeting expectations. If you don’t track your time, you can’t bill for it.
In recent years, medical communicators have been creating documents called plain language summaries (PLS) to help patients, caregivers, and the general public to better understand the latest scientific findings and clinical trial results.
The terms plain language summaries (PLS), plain language summaries (PLS) for clinical trials, plain language summaries for publication (PLSP), and plain language writing can be confusing — and are sometimes used interchangeably. Although each term has a different application, the documents share a single goal: to work toward inclusion and empowerment of nonexpert audiences.
What’s your style? Are you an AMA person? An APA aficionado? Does your employer use a house style guide?
For freelancers, perhaps the more important question is: What writing style guide does your client want you to use?
This blog is based, in part, on an AMWA webinar presented by Monica Nicosia, PhD, CMPP.
At this point in history, when so much of our life and work happens online, it is almost hard to remember a time before digital tools were essential for the work of freelance medical communicators.
Even before the COVID‑19 pandemic, which sent so many workers to their home offices, freelance medical writers and editors often worked from home. Remote workers need secure, efficient technology that helps them to balance work lives while maximizing the efficiency of the hours that are billable to clients.
What are the most common digital resources that are essential for freelancers? What types of software are experts recommending to advance and thrive in this line of work?
We do not live in a world where everyone — regardless of race, gender, gender identity, disability status, or income level — has the same access to high-quality health care, adequate housing, or nutrition. As a result, health outcomes are vastly unequal, causing marginalized populations to experience lower life expectancies and higher levels of preventable diseases.
So much of our lives is connected online these days, and freelance medical communicators are using tools that allow collaboration with colleagues around the world.
This level of connectivity requires attention to cybersecurity to make sure data and key information are accessed only by people who are authorized to see them. As a medical communicator, what can you do to protect yourself, your personal data, and your clients’ critical information from cyberattacks?
We live in an increasingly globalized world, and the field of medical communication is no exception. In fact, most medical writers and editors are creating materials for a global scientific audience.
A number of helpful resources, online and in print, exist to help people write clear, translatable prose for global audiences.
Apprenticeships are an age-old institution used to guide people in their careers and help them develop the skills they need to succeed. AMWA has an ongoing interest in exploring the value of apprenticeships and similar training programs, including hosting the Fourth Annual Medical Writing Executives Forum, which took place during the 2022 AMWA Medical Writing & Communication Conference.
Careers in medical communication require a number of basic qualifications and skills, which can be enhanced by participating in a medical writer apprenticeship.
Freelance medical writers typically work on projects for varying amounts of time, depending on the project parameters. However, on occasion, clients may want a freelancer to commit to being available to them for a set period of time rather than for a specific project. What is a long-term contract, and what should you do when a client offers you one? Let’s start at the beginning.
There’s plenty of reason for concern about the evolving role of artificial intelligence (AI) in almost every aspect of our culture and economy. In medical communication, concerns about the increased use of AI intersect with issues on authorship.
Fake political news has dominated the headlines over the past few years, but the proliferation of science denial and misinformation about health and medicine has also caused widespread concern.
Are you a regulatory medical writer who is concerned about proving your mettle?
Regulatory medical writers play a critical role in the drug development and approval processes. Yet their role is often misunderstood and undervalued.
Scientists are having a rough go of it right now. They are being harassed at record levels, especially for sharing public health information related to the COVID-19 pandemic.
It’s gotten so bad that scientists on Twitter are “heading for the exit.” In this climate, how can medical communicators increase the public’s trust in science?
Are you prepared for the next generation of science communication?
These days, inaccurate science can spread online like an out-of-control pandemic, but medical communicators are often the first line of defense against medical disinformation.
By paying attention to the advances in technology and the needs of particular audiences, medical writers and editors can help create and disseminate materials that will help consumers assess conflicting claims.
By Robert J. Bonk, PhD
Medical communicators need a level of conversance with terminology and concepts in the field of health economics as cost becomes an outcome for treatment decisions. This blog introduces the fundamentals of health economics to medical communicators.
What role do medical communicators play in the world of health care reimbursement?
In the United States, health care reimbursement and access is a complex process that involves multiple parties known as payers (or payors): insurers, national health entities, and other decision-makers. The goal is to provide effective health care to patients while also weighing the costs of drugs, devices, and procedures in order to develop plans for formularies.
As health care costs continue to rise, medical communicators can play a role in health care policy and practice by participating in Health Economics and Outcomes Research (HEOR)—a growing field with opportunities for medical communicators.
What is HEOR, and how does it contribute to scientific knowledge? What are the guidelines for reporting results of HEOR studies?
As independent businesspeople, freelance medical writers are responsible for acquiring their own insurance policies. Some types of policies are critical for operating a business, while others depend on the structure of one’s freelance business.
No one is perfect.
Even the best medical writers make the occasional mistake. That is why it is important to use every tool at our disposal to make sure that each project’s content, style, and format are high quality.
Randomized controlled trials (RCTs) are the foundation for advancing clinical practice. However, not all RCTs are created equal. To communicate how an RCT was designed and what it found, authors must report clear and accurate information about its methodology and results. Unfortunately, many reviews have shown that authors often don’t provide complete and transparent information about the clinical trial, which can lead to misinterpretation of the validity and reliability of the results.
Conventional wisdom says you could be the best freelance medical writer in the world, but unless you have a website, potential clients might not know you exist.
If patients and consumers don’t understand patient education materials — or don't know what action to take after reading or viewing them — those materials aren’t doing their job.
The result could be confusion, disengagement, or poor health outcomes.
But how do we know whether health education materials are effective? One important health literacy tool that is used to assess patient education materials is the Patient Education Materials Assessment Tool (PEMAT).
Scientific manuscripts are rarely the work of one author. They are the result of complex collaborative relationships. This reality begs the questions: Who is the author of a scientific manuscript? When is someone credited as an author, and when are they considered a non-author contributor?
Storytelling is the basis for human connection, with oral and written traditions stretching back for millennia.
Our brains have evolved to respond to stories.
It is not only patients and consumers who respond to excellent stories. Scientists and health care professionals are also humans with emotional and intellectual attachments to engaging narratives.
One of the most useful acronyms in a medical communicator’s toolkit is IMRAD.
It stands for the sections of a scientific research paper: Introduction, Methods, Results, and Discussion.
By Stephen N. Palmer, PhD, ELS, Texas Heart Institute
Use these EndNote tips and tricks to save time and solve problems when citing book chapters, making global text edits, maintaining journal title words and abbreviations, collaborating with other users, and correcting erroneous page numbers and corrupted in-text citations. This Mini Tutorial describes tips for EndNote X7. Exact steps may differ for later versions.
In medical communication, it is critical to ensure that documents and other materials are free from mistakes, inconsistencies, and errors. The stakes are high, and even though few of us reach perfection, it is important to utilize all the tools at our disposal to get as close as we can.
By Laura J. Ninger, ELS, Ninger Medical Communications, LLC
You must understand what your medical communication business has achieved during the past year in order to plan for the future. This blog helps you review your earnings, clients, project mix, and marketing efforts with good record-keeping and some simple tables and graphs.
Writers and editors with a passion for medicine and science are exploring opportunities in the growing field of medical writing.
The explosive growth of health care technology, pharmaceuticals, and other related areas creates multiple possible entry points for writers and editors who possess the skills and qualifications to enter and advance in the field.
The National Institutes of Health (NIH) invests more than $32 billion per year in biomedical research, making it the largest public funder of such research in the world.
The NIH reviews approximately 80,000 applications each year; approximately 20% of those receive funding.
Every quality document requires the attention of a thorough editor, and medical and scientific documents require extra care to uphold scientific rigor.
By Charlotte Crowder, MPH, ELS, Freelance Medical Writer and Editor
Use these tips to help medical writers create plain language, ethically sound informed consent documents with easy-to-read formats for participants in investigative clinical trials.
By Donald Harting, MA, MS, ELS, CHCP, President, Harting Communications LLC, Downingtown, PA, and Ruwaida Vakil, MSc, Principal, ProMed Write LLC, Somerset NJ
A needs assessment (NA) is any passage of text that documents the need for instruction on a particular topic among physicians and other health care professionals. This NA may also be called a gap analysis. Normally the NA is just one part of a larger document, often called a CME grant proposal. Typically this larger document will also include sections on budget, audience generation, and outcomes analysis (Figure 1). A proposal for an accredited activity will also contain some indication of how many continuing education credits may be awarded and information about the organization awarding credit. These additional sections are NOT included in this blog.
Are you taking time for self-care?
Medical communicators need to take care of their minds, bodies, and souls to avoid burnout and health issues.
Copyright law is complicated, and we’re not legal experts.
However, one of the most important aspects of copyright law as it pertains to medical communicators is called “fair use.”
In general, copyright protects the intellectual property of creators like artists and authors, but there is an important exception made when material is used for educational purposes or for other reasons that distinguish it from a profit-generating use.
Product training—or medical sales training—is an essential ingredient in bringing new medical devices and pharmaceutical products to market.
Pharmaceutical, biotech, and medical device companies spend enormous amounts of time and money implementing medical sales training when launching new products or when products are approved for new indications. Creating medical sales training materials is a growing opportunity for medical communicators who can leverage their skills and experience to help bring better products to healthcare providers and patients.
Those in the medical writing and editing field know that job responsibilities vary widely.
Regardless of the job description, medical communicators have unique scientific and professional skill sets that can be used in a multitude of ways. However, medical communicators sometimes find themselves in situations where they are expected to do more than is possible. Perhaps a colleague or client expects a level of support that is beyond the scope of the medical writer’s job description.
Ethical behavior is important in any profession.
Checklists are popular these days. And for good reason.
Ever since surgeon and author Atul Gawande published The Checklist Manifesto: How to Get Things Right in 2009, checklists have proliferated in many fields, and revolutionized the way we conduct business and practice medicine.
The American Medical Writers Association (AMWA) has selected Leana Wen, MD, MSc, FAAEM, an emergency physician, public health professor at George Washington University, and nonresident senior fellow at the Brookings Institution, as the 2022 Walter C. Alvarez Award Recipient. This award recognizes excellence in communicating health care developments and concepts to the public and is named after Walter C. Alvarez, MD, a pioneer in the field of medical communication.
Wen’s career has focused on public health as a fundamental force in our individual lives and well-being. Previously, she served as Baltimore’s Health Commissioner, where she led the nation’s oldest continuously operating health department in the United States to fight the opioid epidemic, treat violence and racism as public health issues, and improve maternal and child health. She directed the public health recovery efforts of Baltimore after the 2015 riots, working to ensure access to prescription medication after pharmacy closures and working to develop the city’s mental health and trauma recovery plan with crisis counseling, youth health and wellness, and violence prevention programs. As she states in her memoir, Lifelines, “Public health saved your life today―you just don’t know it.”
The American Medical Writers Association (AMWA) has selected Peter J. Hotez, MD, PhD, an internationally recognized physician-scientist, global health advocate, accomplished author, and 2022 Nobel Peace Prize nominee, as the 2022 John P. McGovern Award Recipient. This award recognizes preeminent contributions to the various modes of medical communication and is named in honor of renowned allergist and philanthropist John P. McGovern, MD.
Based in Houston, Texas, Hotez is a professor of Pediatrics and Molecular Virology and Microbiology at Baylor College of Medicine, founding Dean of the National School of Tropical Medicine at Baylor College of Medicine, professor at Baylor University, and codirector of Texas Children's Hospital’s Center for Vaccine Development. Considered a pioneer in his field, Hotez is an expert in neglected tropical diseases, global health, and vaccinology with a passion for developing new interventions, combatting anti-science misinformation, and communicating science.
Have you taken a stretch break in the last 15 minutes? Do it! Lift your arms up above your head and tilt back slightly to counteract that forward curve. Yes, we’re talking to you.
Like other professionals, medical communicators tend to spend a lot of time at their desks. We’re looking at screens, meeting online, poring over documents, talking on phones, and researching and writing.
Your time as a medical writer is worth money.
However, clients can change their minds, project leads can move on, and some projects are discontinued, due to circumstances we don’t control.
Pharmaceutical companies look to medical advisory boards to help shape the big‑picture aspects of their work. Are their products benefiting patients and health care professionals? Can they do a better job of meeting the needs of patients?
This article is based on content presented by Monica Nicosia, PhD, Nicosia Medical Writer LLC, Bryn Mawr, PA, at the AMWA Medical Writing & Communication Conference.
Writing for scientific publications is at the heart of the medical writer’s mission.
What are these publications looking for? And how can medical communicators streamline and improve the process to deliver excellent copy and increase the likelihood of publication?
Have you been asked to sign a confidentiality agreement as part of a medical writing or editing contract?
Nondisclosure statements or confidentiality agreements are not unusual in the medical communication field. They are common documents clients use to protect the information or knowledge writers and editors encounter as they work on a project.
This blog is based on content presented by Kathi Whitman, MA, Senior Medical Writer/Project Manager, Intermountain Healthcare, at the AMWA Medical Writing & Communication Conference and published in AMWA Journal v 31 n 4.
Making medical decisions can be challenging and frustrating. So many options and possible treatments exist, and doctors aren’t supposed to tell patients what to do.
One of the more direct applications of medical writing skills is helping patients to make informed choices about their health care.
People take different paths in their journeys to become medical writers. Some are scientists and clinicians who come to the field with medical or scientific backgrounds. Others are professional writers who want to leverage their background in communications to write about science and medicine.
Medical writers can find vast amounts of information about prescription drugs and biologics from a variety of resources, such as scientific publications, electronic databases, and free online content from sites such as drugs.com.
A challenge for medical writing professionals is sorting through these resources to find information that is accurate and acceptable to use as a reference source when writing content that will ultimately go through medical‑legal review.
The hunt for freelance medical writers and editors begins when you have a need for a communication professional who can help you complete or improve your writing project. Sometimes you have an urgent need, and you don’t know where to turn.
Your first call will be to trusted freelancers, people you have worked with before. As any client working on a tight timeline knows, chasing down new freelancers in a pinch is exhausting, time consuming, and stressful. The key is to cultivate successful partnerships so you have a pool of freelancers who are eager to work with you when you need them. Why are they eager to work with you?
An academic grant writer is a medical communicator who is hired for their medical writing or editing skills to support either an academic scientist or a department (typically within a research institution or university/school).
Grant writers and editors help to ensure that research grant proposals satisfy the funder’s guidelines and provide a clear, concise, evidence-based message about why the research should be funded.
How do medical communicators distill the results of complex studies into just a few hundred words?
Many times, they do it by writing conference or meeting abstracts.
How familiar are you with the language of freelance contracts? Do you know how to spot a problematic contract clause?
As a freelance medical communicator, you are running your own business. Even if you’d rather be writing than wading through legalese, learning the basics of contracts is part of the job.
A clinical study report (CSR) is a comprehensive regulatory report describing the data and outcomes observed in a clinical study.
Imagine a toolbox without a hammer.
Medical communicators have toolboxes too. Visuals, such as tables and graphs, belong in that toolbox. We are telling scientific stories, and data are important elements in many of those stories.
An essential skill for medical communicators involved in creating materials for continuing medical education (CME) activities is learning to identify a practice gap by conducting a gap analysis.
How are you with numbers?
It’s important for all medical communicators to master the essentials of medical statistics. Medical writers are not the ones carrying out statistical tests or procedures, but they may be responsible for interpreting and reporting statistics.
This blog is based on content presented by Scott Kober, MBA, and Eve Wilson, PhD, ELS, FACEHP, at the AMWA Medical Writing & Communication Conference, as well as a panel discussion co‑hosted by AMWA’s Delaware Valley and Mid‑Atlantic chapters.
Crafting compelling case studies is a marketable skill for medical writers, especially those working in continuing medical education (CME). Demand is strong among medical education companies for freelance writers who can write brief screenplays for patient case simulations delivered via proprietary computer platforms.
Both terms describe someone who communicates medical and health information to specific audiences.
A medical technical writer is another term used to describe a medical writer. From our perspective, the terms are interchangeable. Medical writing is technical writing for medical and health concepts.
This blog is based on content presented by Deborah Anderson, PhD, MT(ASCP)SH, at the AMWA Medical Writing & Communication Conference.
The term “instructional design” may not sound familiar to some medical writers, simply because they were never formally taught this concept during their education. However, many writers incorporate the principles of sound instructional design in their medical writing without realizing it. In most instances, they develop these skills while learning on the job.
Freelance success is possible. As today’s work landscape rapidly changes, more talented professionals are leaving traditional employment settings, or are interested in supplementing their income, and are finding value in the flexibility and economic opportunities presented by freelance work.
One niche for medical writers is grant writing. Whether they are writing grant proposals to fund continuing medical education (CME) programs or to support biomedical research, grant writers are tasked with convincing funders that the project is needed now, and that their team is the best one to undertake the project on time and within budget.
Proposal writing combines persuasive writing skills and a thorough understanding of scientific literature on the topic of the proposal. This guide introduces medical writers to the essential questions all grant writers need to answer before starting a writing project.
This blog is based on an article written by Donald Harting, MA, ELS, CHCP, and Nathalie Turner, ELS, that was originally published in the AMWA Journal, and on content presented by Harting, Turner, and Katherine Molnar-Kimber, PhD, at the AMWA Medical Writing & Communication Conference.
Needs assessments are a critical step in the development of continuing education for health care professionals. Medical communicators working in this professional focus area are likely to participate in creating needs assessments.
When people are looking to establish or further a career as a medical writer, they often have questions about the differences between earning a certificate in medical writing and certification, which means earning the Medical Writer Certified (MWC®) credential.
As a medical writer, chances are high that you’ve crafted a document or two without your byline attached. After all, much of the content medical writers create doesn’t require authorship. If you’re interested in advancing your career and seeing your name in print, consider medical journalism. Nurturing relationships with publications that focus on health and well-being for a public audience is also a smart move for freelance medical writers. Having bylined publications can fortify your position as an expert in medical communication.
This article is based on content presented by Lori De Milto, MJ, Kelly Schrank, MA, ELS, and JoAnna Pendergrass, DVM, at the AMWA Medical Writing & Communication Conference.
If you're considering a career as a medical writer, there are a few ways to enter this challenging, lucrative field. If you're an experienced communication or medical professional, you're off to a good start. Still, you'll want to spend time exploring professional resources, brushing up on medical terminology, and honing the specific skills necessary for your chosen area of focus.
Talking so everyone can hear
We have heard the words “equity” and “inclusion” many times in recent months. But we may not all have connected them with our work as writers and editors in health, medicine, and science. How can medical communicators help create a more equitable, inclusive world?
As writers and editors, we can play a role in giving all people the opportunity to understand and use health information so that they can participate in clinical trials, understand their health care providers’ instructions, and take other actions that help reduce and eradicate social, economic, and health disparities.
If you’re a new medical writer, you probably find yourself looking for templates and document guidelines to help you organize your work. Whether you’re a new graduate or an experienced scientist pivoting into a new career, you’ll need to spend time learning the purpose of each type of medical document in your niche and structuring it properly. Below, we offer an explanation of and guidance for writing clinical case reports.
As a regulatory writer, you must stay updated on new policies and evolving best practices for highly technical documents. Continuing education is important for both maintaining and advancing your career. That includes brushing up on everything from medical device writing to pharmaceutical writing. Below, we review the expectations for protocol writing, then follow up with four best practices for success as a regulatory writer who specializes in these types of documents.
When you imagine applying for a new medical writing job, how do you feel? Does your heart race with excitement? Do you feel a flicker of fear? Pivoting into a new position, company, or niche can be both exhilarating and challenging. It’s important to do everything you can to set yourself up for success.
Freelancing allows medical writers to take command of their careers by establishing and managing their own businesses. Owning a freelance medical writing or editing business empowers you to set your rates and schedule. As a freelancer, you’ll experience an equal mix of freedom and responsibility.
If you’re a new medical writer, you might be wondering how to set yourself up for a long, successful career. Fortunately, there are many ways to build a strong foundation: exploring apprenticeships, mastering medical writing styles, and earning an Essential Skills Certificate, to name a few.
As a freelance medical writer, you must master a variety of business skills in addition to writing high‑quality documents. You’ll need to set your rates, market your business, and even determine when and how to subcontract work, if that’s your business model.
In Entrepreneur’s May 2020 article “What You Can Learn from Freelancers Right Now,” journalist John Boitnott outlined why freelancers are equipped with the best tools and practices for high‑quality, productive remote work.
The medical communication field is well established and growing rapidly. From regulatory writing to medical copywriting, many paths, employers, and projects await newcomers to the profession. Whether you're a new graduate, a veteran marketing writer, or even a scientist interested in expanding your skill set, medical copywriting could be a lucrative niche.
Whether you're hoping to expand your portfolio to include medical journal writing or are already incorporating journal articles into your medical writing career, it's helpful to refresh your awareness of best practices.
If there’s one key to success as a freelance medical writer, it’s this: never stop marketing.
The economic fallout from the COVID‑19 pandemic has affected thousands of career paths, including many in the medical communication field. Whether you’re seeking new remote work opportunities or hoping to expand your skill set to further advance your career, consider pursuing writing in the pharmaceutical industry.
The medical communication field is expanding at a record pace. At the same time, remote work is becoming mainstream. By demand, many experienced medical writers have begun offering freelance writing or editing services.
If you’re a new medical writer, you may wonder which skills are essential for success. Whether you choose to write regulatory documents, promotional content, patient education materials, or journal articles, you’ll need a strong writing foundation. Part of that foundation includes learning to understand, write, speak—in general, to communicate!—using the jargon of the field: medical terminology.
Melory Johnson, Owner and Principal Medical Writer, MJ MedComm, LLC, contributed to this article.
Whether you’re an established medical device writer or another type of medical communicator hoping to advance your career by adding a new skill, it can be helpful to brush up on best practices of medical device writing. Below, we outline the defining qualities of this niche, then describe how to succeed as a medical device writer.
This blog is based on an article written by Misty Bailey, MA, ELS(D), Kirsten Benson, EdD, and Anne Marie Weber‑Main, PhD, that was originally published in the AMWA Journal.
As a medical editor, your challenge is to use techniques that effectively balance the need for clarity with respect for the authors’ ideas. In other words, communication approaches need to empower authors while accomplishing the common goal of producing an easy‑to‑read piece of writing that clearly and effectively communicates the authors’ message and intent.
Medical writing can be a lucrative, rewarding career, but it takes a commitment to understanding grammar and stylistic guidelines. A solid grasp of grammar, punctuation, and medical word usage is required. Some errors are common among new medical writers and even among some experienced medical communicators. A good place to begin fortifying your writing foundation and preventing these errors is a medical style guide.
This article by Jodi Braunton was originally published in the AMWA Journal.
This article, written by Peggy Boe, RN, and Barbara Snyder, MA, was originally published in the AMWA Journal.
Regulatory writers are often faced with ethical situations, though we may not always recognize them as such. The way we define ethical behavior in general is based on our personal upbringing, religious beliefs, culture, and environment. Ethical behavior in the workplace is further defined by our employers, professional organizations, and in some cases, even the government.
Amid ongoing global health issues and a shifting economy, many experienced medical writers recognize an opportunity to expand their skill sets. For writers interested in moving into health communication, it is crucial to understand the difference between writing for a professional audience and communicating health information to the general public.
This article is based on content presented by Katherine Molnar‑Kimber, PhD, Kimnar Group LLC, and Deborah Anderson, PhD, DGA Medical Communications, at the AMWA Medical Writing & Communication Conference.
For freelance writers and independent contractors, establishing long‑term client relationships has clear advantages. Working with long‑term clients reduces time spent on administrative tasks, such as marketing, acquiring resources, and learning new formats, which increases the time available for producing the deliverable. The stability provided by long‑term clients also improves peace of mind and is usually financially beneficial.
This article is based on content presented by Brian Bass, MWC, and Emma Hitt Nichols, PhD, ELS, at the AMWA Medical Writing & Communication Conference.
Brian Bass and Emma Nichols have over 24 years of combined experience in hiring and working with freelance medical writers. Their education session focused on outlining the major considerations for freelance medical writers who are thinking about bringing on subcontractors—providing advice and guidance on making this decision and supporting their transition.
This article is based on content presented by Laura J. Ninger, ELS, at the AMWA Medical Writing & Communication Conference.
Note: The tips here are meant to provide an overview of best practices regarding accounting needs for freelancers. For advice specific to your situation, seek counsel from authorized financial experts.
For freelance medical writers and editors, day‑to‑day responsibilities include managing a business in addition to producing quality content. But collecting receipts, preparing for quarterly taxes, and staying on top of business accounting can be a major source of stress.
If you are a freelance medical writer overwhelmed by accounting, these tips are for you.
True or false:
Well-trained medical communicators bring value to the teams with whom they work.
I hope you answered true because that’s the right answer.
The key adjective of course is well-trained.
Many medical writers are tasked with more than crafting accurate documents. You might also need to manage projects and teams.
Part of managing medical communication includes effectively leading meetings so that they drive documents forward to successful completion.
Whether you're preparing to lead your first meeting or kicking off a new project, follow these best practices to meet your objectives. These best practices apply whether your meeting is in‑person or online.
This article is based on content presented by Eleanor Mayfield, ELS, at the AMWA Medical Writing & Communication Conference.
How to calculate freelance medical writing rates is a hotly debated topic among freelancers. Some are adamant about always charging a project fee; others swear by an hourly rate. Eleanor Mayfield led a discussion of the pros and cons of these common methods as well as strategies for implementing them that will benefit both freelancers and their clients. She stressed that no pricing method is perfect; the key is to determine which strategy is the best fit for each project.
You’ve just been named employee of the month. Hooray for you! Actually, when you’re a freelance medical writer or editor and you work for yourself, you are your own employee of the month EVERY month because there's no competition for the crown. The question is have you done all it takes to deserve that honor?
To work in health communication, you need both detailed knowledge about health care and marketing and the ability to manage a variety of editorial and writing tasks.
Whether you’re starting out in health communication or considering a shift from another type of medical communication or medical writing, these tips can help you succeed.
For freelance medical writers and editors, social media can help build authority, engage with colleagues, connect with potential clients, and grow their freelance businesses. But posting and sharing inconsistently, or using the wrong platforms, can waste time and energy. These social media marketing tips can help.
Medical communicators do more than write. As a project manager, your role can include managing documents, processes, timelines, and people, sometimes across multiple teams. Effective project management is essential for success with complex projects, especially when they involve the drug development cycle.
For some medical writers, a next step in their careers is a move to management. While this can create opportunities for advancement and greater recognition, it can be challenging—many medical writers are seasoned communicators, but they may not yet have the skills required to manage others.
To make a successful transition, these tips for new managers can help.
Freelance medical writing can be a lucrative, rewarding, and flexible career. Yet even if you have been writing professionally for years, you may have questions when it comes to how to create a solid client base and find steady work. The following tips can help you start your own freelance medical writing business.
This article is based on content written by Kelly Schrank, MA, ELS, and presented by John West Hadley at the AMWA Medical Writing & Communication Conference. It was originally published in the AMWA Journal.
Making sure you move ahead in your medical writing career calls for finding opportunities to create visibility for your skills and achievements and presenting yourself and your work in the best light. This means showcasing your value not only to potential new employers and clients, but also to your current employer in order to justify your salary and position yourself for advancement.
A structured and systematic approach can be effective, starting with these three steps.
This article was originally published in the AMWA Journal.
All of us have suffered the consequences of expensive, unasked questions in both our professional lives and our personal lives. As medical communicators, we must ask good questions to elicit information, but many of us lack adequate training in this skill. Add to that the natural reticence of some medical communicators, and it is no wonder that we walk away from interviews with subject matter experts or client meetings wishing we had remembered to ask X, Y, or Z. This article offers information as to why questions are so important, what types of questions are useful, how to strategize your questions, how to handle people answering the questions you ask them, and how to answer questions that others ask you.
This article is based on content presented by Debbie Dakins and Colleen Cronin, at the AMWA Medical Writing & Communication Conference. It was originally published in the AMWA Journal.
You’ve heard the phrase “Put words into action”? Well that, my friends, is what I’m going to attempt to do here. In this recap of the 2016 AMWA conference presentation “Six Steps to Writing Content That Moves People,” I will try to apply what I learned from Debbie Dakins and Colleen Cronin’s tips to help writers create informational materials for the general public that can inspire and motivate people to make changes to improve their health and wellbeing.
This article is based on content presented by Kathi Whitman, MA, at the AMWA Medical Writing & Communication Conference. It was originally published in the AMWA Journal.
Imagine your loved one has been newly diagnosed with a chronic disease such as end-stage renal disease, breast cancer, or obstructive sleep apnea. Owing to the stressful diagnosis, your loved one may have trouble taking in new information and choosing among numerous treatment options within a limited time. Can your medical writing skills help this difficult process?
As medical writers, the heart of our work is to convey information to a specific audience. Writing for patients, we are trusted with interpreting highly technical information to educate, protect, enable, and empower our readers. The result of poor understanding can be directly harmful to health. However, successfully informing patients leads to better health outcomes, including more preventative care and fewer hospitalizations.
In this post I offer 3 questions that will help you use plain language effectively and successfully when writing for lay audiences.
This article is based on content presented by Lori L. Alexander, MTPW, ELS, MWC, at the AMWA Medical Writing & Communication Conference. It was originally published in the AMWA Journal.
Continuing medical education credits are often awarded based on answers to test questions, so it is essential that the questions be designed well.
Research shows, however, that “almost half of all test items have flaws,” said veteran continuing medical education writer and editor Lori Alexander. This problem is driving the need to develop better test items and is creating job opportunities for medical writers and editors. In this open session, she explained how to write test items using guidelines and best practices from the National Board of Medical Examiners and the American Board of Internal Medicine.
This article is based on content presented by Kent Steinriede, MS, at the AMWA Medical Writing & Communication Conference. It was originally published in the AMWA Journal.
“Find out what the story is,” Kent Steinriede stressed throughout his session about the quality control (QC) review of safety narratives. Steinriede highlighted the elements of the safety narrative, source documents and tools used in QC review, and tips for best QC work.
What is a servant leader? Servant leaders know their employees as whole people and strive to be a positive force in their lives. They build a first-hand understanding of the workplace. They create teams, address disparity, and create a vision for the growth of individuals and business. While most leaders are considered bosses or supervisors, all of us can serve as leaders to our colleagues and to peers as well. To start the path to leadership, it’s important to understand the qualities needed to act as a servant leader.
I don’t make my living as a writer; let’s get that out of the way right now. However, I recruit writers and managers/directors of groups of medical writers, and I’ve been a mentor to many people. I’ve seen people succeed and fail, overcome obstacles and get back up again. A mentor or two (or more) can catapult an average career into a stellar career if you align yourself as early as possible with people who will be in your corner as you navigate your future.
This article was written by freelance medical writers Lori De Milto, Elizabeth L. Smith, and Cathryn D. Evans. It was originally published in the AMWA Journal.
There are good reasons to specialize in certain types of projects and/or therapeutic areas—and good reasons not to specialize. In general, if you’re a new freelance, you should focus more broadly to attract more clients. As you gain experience, you can narrow your focus, which is what I did.
It's fun to look back over the years and think about fashion trends that probably never should have seen the light of day. I’m thinking mullets, shoulder pads, and why not throw in bell bottoms while I’m at it.
Although fashion trends come and go, trends in medical communication usually point toward practices that are here to stay. We can’t afford to ignore industry trends if we want to remain fresh and relevant. Whether we are employees or freelances, we never want to become stale, and staying on top of business trends should be part of our jobs.
Recruiters can make all the difference when advancing your medical writing career. Experienced recruiters can help you identify a role that increases your earning potential, improve your work/life balance, and move you up to a senior-level position.
Many medical writers aren’t sure how to effectively find and work with recruiters. Some may not think they need to work with recruiters. However, used in conjunction with other job search strategies such as industry job postings (available to AMWA members), working with a recruiter can be a good way to make critical connections that will help you land your ideal next job.
Writing and editing go hand-in-hand to create a masterpiece. A well-written article is like a fine piece of jewelry. Think of the content as the design of the jewelry and the editing as the polish. Just as a ring without polish looks like a piece of lackluster metal with a potentially beautiful gem, a poorly edited article loses its charm even if the content is strong.
Until recently, most writers in the field of medical communication entered the field without formal training. Some started out with scientific or medical degrees and previously worked as scientists, physicians, or pharmacists before transitioning into medical writing. Others began as journalists and built a career by writing about health and medicine.
Health literacy is important for improving people’s long-term health and quality of life. In an ideal society, health literacy would be high and people would regularly take preventative measures to protect their health, manage chronic conditions, and have better health outcomes.
In medical communication, as in other fields, it’s increasingly common for team members to be scattered across the country or around the globe. It’s important for managers to have the skills needed to make their remote teams successful—no matter where employees are located. Managers of remote medical communication teams face challenges including
Here are some tips for addressing the challenges of managing a remote medical communication team.
A medical writing career requires being a lifelong learner and networker.
To begin working in the field, medical writers need specialized skills and knowledge to obtain jobs. Advancing in the field means constantly building on that base. In addition, professional connections are helpful in the beginning of your career and in order to advance.
For most medical communicators (and humans), time is one of our most valuable resources. When I think about whether to attend a professional conference, I have to consider its value. Who am I going to meet? What am I going to learn? How will this conference bring value to my business and career? I think we should also add another question to this assessment list: Will this experience reinvigorate my passion for my work? Will this time add to my personal development?
Did you know that today we receive 5 times as much information as we did in 1986? This amount is the equivalent of 174 newspapers of data a day. It’s not surprising that many of us feel as though we have information overload, especially when some of what we read and hear is false.
Combating the glut of misleading information out there on the web can be a challenge. If you find yourself becoming stressed and disturbed by the rise in scientific inaccuracies you encounter, the American Medical Writers Association (AMWA) 2019 John P. McGovern and Walter C. Alvarez Award winners may offer some relief.