Becoming a Medical Writer
Transcription
Becoming a Medical Writer
Becoming a medical writer How to launch a successful career writing about medicine & health Diego Pineda, MS Note: Please read the disclaimer of warranty and limits of liability regarding the contents of this e-book. © D&D Books 2007 - All Rights Reserved About the Author D iego Pineda is a passionate medical writer. After obtaining a master’s degree in science and technology journalism from Texas A&M University he went to work for the nonprofit organization Immunizations for Public Health (i4ph) as a science writer. In this role, he has written more than a hundred articles on vaccines and immunizations, many of them published on the Web site of the National Network for Immunization Information (NNii). Diego is the co-author of Do Vaccines Cause That?! A Guide for Evaluating Vaccine Safety Concerns and the bestselling booklet Are Vaccines Safe? Evaluating Information about Immunizations on the Internet. As an officer in the Southwest chapter of the American Medical Writers Association (AMWA), he is actively involved in the medical writing community. He has also been invited to lead roundtable discussions and open sessions at the AMWA annual conference. Diego lives in the Houston-Galveston area with his wife and two sons. Visit his Web site at diegopineda.com and his medical writing blog at medicalwriter.blogspot.com. Table of Contents How to get the most out of this book—5 Those Burning Questions What is a Medical Writer?—9 Do I Need to Be an M.D. to Become a Medical Writer?—14 How Much Can I Earn as a Medical Writer?—24 Should I Work for a Company or be a Freelancer?—28 Should I Focus on Clinical or Consumer Health Writing?—31 Writing for the Pharmaceutical Industry An Overview of the Industry—35 Regulatory Writing—38 Medical Marketing Communications—44 Medical Education—48 Technical Documentation—50 Getting the Job: Recruiters, Resumes, and Interviews— 53 Consumer Health Writing Writing for Consumer Health Magazines and Web Sites— 59 Breaking into Consumer Health Writing—63 Other Medical Writing Opportunities Academia, Hospitals, Nonprofits, and More—73 Public Health and Policy Writing—75 Becoming a Medical Writer Grant Writing and Editing—78 Working as a Freelance Medical Writer The Freelance Path—83 How Much Should I Charge?—87 Attracting Clients—91 Professional Organizations for Medical Writers and Editors—96 Sample Job Postings from AMWA’s Job Market—107 Recommended Resources—117 Introduction How to get the most out of this book A lthough you will find some writing tips here, the scope of this book is not to teach you how to write medical articles, or how to write better in general—there are many other books that can teach you that, some of them referenced in Recommend Resources towards the end of the book. Rather, Becoming a Medical Writer is a comprehensive guide to the various routes into medical writing, a tool for launching your new career. If you are completely new to medical writing—you are still wondering whether this is about writing prescriptions—I suggest you first read through the whole book once and then re-read the book with the following ideas in mind. If you have some previous knowledge about medical writing but are not sure where to start, you will be wise to take note of these ideas from the first pass. • Take charge of your future. As you begin a career in medical writing, friends, family, and other people may tell you what they think you should do: “Why don’t you apply for a job at XYZ company? I heard it was good,” or Becoming a Medical Writer “Why are you going back to school at your age?” Don’t let others decide for you. Read this book and the recommended resources. Gain some knowledge. Join a professional organization. Then choose where you want to work and how to get there. • Identify your strengths and desires. Think about your previous jobs and your education. What were you always good at? What is your area of expertise? How can you exploit those strengths in medical writing? You will find that some types of writing require different skills and background. Pay special attention to the types of writing that match your strengths. But don’t forget your desires. Maybe you are tired of your area of expertise and want to try something new. Then focus on what you like and assess realistically whether you can accomplish that. • Create your own definition of success. In other words, set your own goals. Write them down. Would you be successful earning $100,000 or more as a freelance writer? Or would you be successful earning $100,000 as Chief Medical Writer at a company? • Invest time and money in your new career path. Reaching your goals will require some effort and resources. Perhaps you’ll need to take some courses or even obtain a degree—those cost time and money. Or perhaps what you need is work experience in medical writing—you Becoming a Medical Writer may need to spend a few months or a year in an entrylevel position to gain experience, make contacts, and get a sense of the market. Whatever it is, don’t be afraid to invest—you’ll see the payoffs in the future. • Develop a plan of action. Read this book. Take notes. Review your list of strengths and desires and your definition of success. Now write down the specific activities you need to do to reach your goal. It may look like this: 1. Join the American Medical Writers Association 2. Enroll in a certificate program 3. Send resume to a recruiter 4. Create business plan for freelance business Add a timeline to your plan of action and check off any completed items. If you commit yourself to follow your plan, you’ll surely succeed. I hope you do. Those Burning Questions CHAPTER 1 What is a Medical Writer? Writing is easy: all you do is sit staring at the blank sheet of paper [or your computer screen] until the drops of blood form on your forehead. Gene Fowler T wo years into his post-doctoral fellowship at MD Anderson Cancer Center in Houston, Steve Palmer real- ized that he didn’t want to spend his life doing research. “To be a successful researcher you have to be very programmatic and keep doing the same kind of stuff,” he says. “I was not interested enough in any one thing to make that my life’s work. But I did like to write.” Steve had never heard of medical writing until one of his wife’s friends mentioned it during lunch one day. “I was quite curious about it.” Shortly afterwards, Steve met the then president of the American Medical Writers Association (AMWA) who gave him a couple of freelance assignments and later offered him a job at The Texas Heart Institute as a Scientific Medical Writer. 10 Becoming a Medical Writer Steve works with scientists at the Heart Institute to write articles for publication in medical journals. Medical writers like Steve Palmer write about complex topics in such a way that scientists with no background in the topic (and even non-technical readers) can understand it—which brings us to the most important consideration of every writer: the reader. Medical writers can have different kinds of readers, depending on their work or type of publication. For instance: • Some medical writers write for the general public; • Others write for health professionals; and • Others write documents for regulatory agencies like the Food and Drug Administration (FDA). The purpose of the medical writer’s work ranges from advertising to public health education. Consider the variety of occupations of the more than 5,000 AMWA members: • Administrators • Advertisers • Audiovisual Producers • Authors’ Editors • College and University Professors • Journal Editors • Pharmaceutical Writers, Editors, and Managers • Public Relations Specialists Becoming a Medical Writer 11 • Publishers • Reporters • Researchers • Scriptwriters • Statisticians • Translators Do you see yourself in such positions? As a medical writer you can work for government agencies, journals, hospitals, nonprofit organizations, pharmaceutical companies, book publishers, universities, or as a freelance writer. Medical writing can be an exciting and rewarding job— you get to work with remarkable scientists while communicating information that will improve the health of many people. In the words of the late Victor Cohn, science writer for the Washington Post for 25 years: “A good medical reporter is privileged to contribute to the great fabric of news that democracy requires. There is no more important job than giving people the information they need to work, to survive, to enjoy life, to participate in and maintain a free democratic society. “A good medical reporter also has fun, fun talking to some of the world’s most dedicated and interesting people, fun writing copy that zings and captures the reader, fun that injects passion into the job, for it is a job that needs passion.” 12 Becoming a Medical Writer In the following chapters you will find what you can write about and what the skills you need to be a successful medical writer are. You will also learn how to break into consumer health publications and how to get a job as a medical writer in the pharmaceutical industry. And a lot more. Becoming a Medical Writer 13 “I decided to go into medical writing because the 21st Century will be filled with medical miracles to cure diseases and improve the quality of life for humanity. And with every new discovery, writers will be needed to help scientists, doctors, and researchers tell their stories. Career opportunities will be as boundless as the imaginations of the world’s best minds.” Elaine Voci, Ph.D. Development Director, Cornea Research Foundation of America CHAPTER 2 Do I Need to Be an M.D. to Become a Medical Writer? I see you have an interesting paper in the latest number of Brain. When is the English translation coming out? (Remark to a London physician on the publication of a somewhat obscure paper.) Sir F. M. R. Walshe O ne need not be an M.D. (or other health professional) to write about health,” says Barbara Gastel, professor of medical journalism at Texas A&M University and author of the Health Writer’s Handbook (2nd edition, Blackwell, 2005). “Having a background in the health professions does, however, help one get up to speed more quickly on health topics, and it can provide useful context.” Although many medical writers are M.D.s or basic scientists, a large number have earned their degree in humanities or liberal arts. The 2004 AMWA salary survey found that among the medical writers who participated in the study: “Approximately one-half had earned their highest degree in science (33.8%) or health care, including pharmacy (5.1%), 14 Becoming a Medical Writer 15 medicine (4.8%), public health (3.1%), or nursing (2.4%). Approximately one-fourth had earned their highest degree in the humanities, including English (14.4%), journalism (5.3%), communication (4.3%), or technical writing (2.4%).” Whatever your background, you can become a medical writer if you possess: • The ability to research topics thoroughly • The ability to think critically and logically • The ability to write clearly According to Gastel, there are a number of ways to break into medical writing, and different ones can be best for different people. “Often, it can help to do one or more of the following: take courses in medical writing (or more broadly in science writing), enroll in a graduate program or certificate program in medical writing or science writing, do an internship in medical journalism or a related field, participate in organizations such as the American Medical Writers Association and the Association of Health Care Journalists, and just jump in by applying for a medical writing job or trying to write a medically related freelance piece.” In my case, I took the educational route before jumping in. After graduating from journalism school I enrolled in a master’s program in science journalism and took both writing and science classes. The degree opened the doors to my first job as a medical writer and to freelancing opportunities. 16 Becoming a Medical Writer Choosing the Right Program Perhaps you are a health professional who loves to write. Such was Barbara Gastel’s case, who in medical school discovered her passion for writing. Or like me, you may be a writer curious about science and medicine. On either case, you have to work on your weakness. If you have a strong science background, take some writing classes; if writing is your forte, enroll in some science courses. Fortunately, existing medical writing programs offer alternatives for people of diverse backgrounds. While some require applicants to have a degree in science, others welcome only journalists. Most programs, however, are open to both types of students and adapt their curricula to their individual needs. If you are not sure whether you should enroll in a medical writing program, consider this: salaries increase with education level (see the next chapter). In fact, some companies will only hire writes with certifications such as the one offered by AMWA. Graduate programs Master of Arts in Health Journalism, University of Minnesota (33 credits). This program offers courses in both journalism and public health. The curriculum can be built according to your background, journalism or health care. If Becoming a Medical Writer 17 you have questions, contact the program coordinator Leyla Kokmen at (612) 626-1851, hjournal@umn.edu. Master of Arts in Journalism and Advanced Certificate in Science, Health and Environmental Reporting, New York University (44 credits). This 16-month program trains students in reporting and writing about consumer health for the print media while exposing them to a wide range of important scientific issues. Contact the program director Dan Fagin at (212) 998-7970, sherp.journalism@nyu.edu. Master of Arts in Science-Medical Writing, Johns Hopkins University. This MA program is designed for part-time study with evening or weekend classes. The curriculum includes some courses on writing about health, but no science courses. For more information contact Mary Knudson at (301) 495-9379, mknudson@jhu.edu. Master of Arts and Master of Science programs in Technical and Scientific Communication, James Madison University (36 credits). These programs prepare students in the communication technologies used to produce technical and scientific documents and develop the skills needed to work in industry and academia. Contact the program support technician at (540) 568-8018, tsc-program@jmu.edu. Master of Science in Biomedical Writing, University of the Sciences in Philadelphia (36 credits). This program includes several courses on regulatory writing—a good op- 18 Becoming a Medical Writer tion if you are interested in working at a pharmaceutical or a biotechnology company. For details contact the director of the Biomedical Writing Program, Danny A. Benau, at (215) 596-7509, d.benau@usp.edu. Master of Science in Science and Medical Journalism, Boston University (48 credits). This program focuses on writing and reporting science and medicine for the mass media. For more information call (617) 353-4239 or email Doug Starr at dstarr@bu.edu or Ellen Ruppel Shell at eshell@bu.edu. Master of Science in Science and Technology Journalism, Texas A&M University (33 or 36 credits, depending on track). A comprehensive program designed mainly to prepare students for careers as reporters, writers, and editors specializing in the coverage of science, technology, and medicine. Students choose between an internship track and a thesis track. For further information, contact the program coordinator, Dr. Barbara Gastel, at (979) 845-6887, b-gastel@tamu.edu. Master of Science in Technical Communication, North Carolina State University (33 credits). The program, which can be taken part-time, prepares students for various careers, including medical communication. For more information contact Stan Dicks at (919) 513-7354, sdicks@ unity.ncsu.edu. Becoming a Medical Writer 19 Certificate programs AMWA Certificates, American Medical Writers Association. The American Medical Writers Association (AMWA) offers core and advanced certificate programs through workshops and courses offered at national and chapter conferences. Workshops include all areas of biomedical communications and some basic science. Visit the AMWA Web site for more information. Editor in the Life Sciences Certificate, Board of Editors in the Life Sciences (BELS). BELS developed a test for editors in the life sciences to demonstrate their editorial proficiency. To be eligible for BELS certification, you must usually have a bachelor’s degree or equivalent and at least 2 years of experience as a manuscript editor in the life sciences. Visit the BELS Web site for more information. Medical Marketing Writing Certificate, University of the Sciences in Philadelphia (12 credits). Designed for people with advanced degrees, this certificate can be obtained in as little as four months. For details contact the director of the Biomedical Writing Program, Danny A. Benau at (215) 596-7509, d.benau@usp.edu. Medical Writing and Editing Certificate, University of Chicago. This program offers courses on all types of medical writing. You can sign up for just one course but must complete at least four to obtain the basic certificate. You can also 20 Becoming a Medical Writer earn an advanced certificate when completing more courses. Contact the program office at (773) 702-1682 or send questions about the program to s-medlock@uchicago.edu. Regulatory Writing Certificate Program, University of the Sciences in Philadelphia (12 credits). Designed for those with advanced degrees, this certificate can be obtained in as little as four months. For details contact the director of the Biomedical Writing Program, Danny A. Benau at (215) 596-7509, d.benau@usp.edu. What About Online Courses? Medical Writing Training.com offers accesible online courses on Consumer Health Writing, Regulatory Writing, and more. Also, USP lets you complete the Master of Science or Certificate of Biomedical Writing completely online. Read the experience of an online student in the MS program on my blog. Self-Study and Writing Conferences As an alternative (or complement) to formal medical writing training you can sharpen your skills by regularly reading medical and pharmaceutical journals, textbooks, or primers on statistics, and studying medical terminology. Start building a special library with medical dictionaries, books on writing, and style guides (see Recommended Resources). Becoming a Medical Writer 21 You may also try the AMWA Self-Study Workshops: • Basic Grammar and Usage • Punctuation for Clarity and Style • Sentence Structure and Patterns According to AMWA, “each self-study module includes a workbook with examples and exercises, as well as a CDROM featuring an interactive PDF of the workbook. Selfstudy workshops can be used to acquire credit in AMWA’s core certificate program (2 credits for , 1 for Punctuation, and 1 for Sentence Structure).” Finally, get connected with other medical writers through a professional organization such as AMWA or the Council of Science Editors (CSE). Medical writer Lanie Adamson says she discovered the American Medical Writers Association (AMWA) at the University of Leiden Medical School Library in 1986. “I was doing some research for whatever interested me at the time. I turned the page of the journal and saw an ad for the 1986 conference of the American Medical Writers Association. Be still my heart! I loved to write and was very interested in medicine. I had no idea that medical writing existed.” Almost all medical writers agree that organizations like AMWA were essential at the beginning of their careers. “I joined AMWA and went to my first meeting in 1986,” Adamson says. “It was held at the Los Angeles Press Club 22 Becoming a Medical Writer and I was unnerved about attending a meeting of medical writers when I wasn’t one. The warm reception and encouragement started me on my way. This was an important step toward becoming a medical writer.” The encouragement received and contacts you make at medical writing meetings may be just what you need to break into medical writing (see Appendix A for a list of professional organizations for medical writers and editors). “Taking some of the AMWA courses will connect you with people who hire medical writers,” Adamson says. “The people who teach are often the people who hire.” Successful medical writers often had a mentor—either a professor or a supervisor—who helped them launch their careers as they entered the field. “It was my interest in medicine that made me get involved in ophthalmology and I had a mentor who taught me where to go,” Adamson says. This was true in my case too. During graduate school, my mentor, Barbara Gastel, taught me how to write better. After graduation, I went to work for a scientist who taught me most of what I know about vaccines and infectious diseases. Never underestimate the impact a mentor can have on your career—it can make all the difference in the world. Now let’s talk about money. Becoming a Medical Writer 23 “In a bout of frustrating job hunting in Boulder, Colorado, I thought—why look for the same type of consumer research job in the sciences that you’ve had? Why not take a hike in these Colorado hills? On my walk down the mountain, an idea—technical writer—came to me. “Although I didn’t know what a technical writer was, the day I returned to Cincinnati I met with a professor in the English department to explain my vision on the mountain and ask for advice. Explaining that my background was science, I asked if a writing certificate would be helpful. Instead that day I began my graduate studies in a master’s program in professional writing where I focused on medicine and science. “On completing my graduate studies, I was panicking, not knowing what to do or where I would find a job. Rather than write my resume, I sat down to meditate for direction. On finishing my meditation, I opened the newspaper, read the first ad, and found my next job, medical editor in a neuroscience group. This has been a blessed path for me.” Mary Kemper Medical Editor, Mayfield Clinic & Spine Institute CHAPTER 3 How Much Can I Earn as a Medical Writer? In medical writing, there is no danger in being too precise—only in being imprecise. Edith Schwager, in Medical English Usage and Abusage A 2005 CNN Money article qualified medical writing as an “interesting six-figure job.” According to the re- port, “medical writers in the pharmaceutical industry may start out making $75,000 a year, but can top $100,000 after three or four years ... Once you reach the managerial level, you might make $120,000 or more.” But this is true not only for writers working at pharmaceutical companies. The American Medical Writers Association (AMWA) periodically surveys its members about their salaries. The 2007 survey showed that for freelance writers the mean gross income was $119,295. Not bad for a freelancer working from home with his or her own schedule! If you like to write and have medical knowledge—or at least the willingness to obtain it—there is a place for you among the medical writers’ community. 24 Becoming a Medical Writer 25 Consider this statement by the U.S. Bureau of Labor Statistics: “Demand for technical writers and writers with expertise in areas such as law, medicine, or economics is expected to increase because of the continuing expansion of scientific and technical information and the need to communicate it to others. Legal, scientific, and technological developments and discoveries generate demand for people to interpret technical information for a more general audience.” [Emphasis added] —Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook, 2006-07 Edition, Writers and Editors. That means that job opportunities for medical writers will keep increasing! The AMWA salary survey found that several factors impact the income of a medical writer, including level of education, years of experience, type of company, and being a male or a female (see figure on the next page). If you take medical writing seriously and work your way up, you could earn a six-figure income—many are right now! Keep reading and you’ll learn how. Note: Learn more about the 2007 AMWA Salary Survey on my blog. Or, if you are an AMWA member, check the slides of the survey in the members area (amwa.org). 26 Becoming a Medical Writer Figure 1. Predictive algorithm based on a regression module. This formula can be used to estimate salary for a full-time employee at a company or organization. Begin at the top of the algorithm with a salary of $19,768, which represents the salary for a medical writer or editor who is 21 years old, has 1 year of experience, and has an associate’s degree or less. Add the indicated amounts according to type of employer, experience, educational degree, and sex. Source: FINDINGS FROM THE 2004 AMWA SURVEY By Tinker Gray and Cindy Hamilton. AMWA Journal 2004; 19(4):148. Becoming a Medical Writer 27 Do you live in Canada? The AMWA-Canada Rate and Salary Survey 2005 is just for you. Canadian AMWA members felt the results of the US AMWA Salary survey did not reflect the Canadian market, so they did their own. Although participation in the survey was low, the results may be useful to Canadian medical writers (rates are given in Canadian dollars). “The mean gross annual income of freelances was $72,467 (range, $25,000 to $165,000), whereas the mean gross annual income of employed respondents was $68,156 (range, $45,000 to $96,000). When the number of hours worked per week was taken into account, the standardized hourly rate of freelances was $54.91 (range, $19 to $138). However, when the hourly rate was calculated to include nonbillable hours, the effective freelance hourly rate was $42.08 (range, $14 to $122). The standardized hourly rate of employed biomedical communicators was $34.25 (range, $19 to $53).” (AMWA JOURNAL . VOL. 22, NO. 4, page 181, 2007) The survey also provides rates for specific freelance jobs and products (information not included in the US survey). AMWA members can access the article summarizing the results at amwa.org. CHAPTER 4 Should I Work for a Company or be a Freelancer? I love being a writer. What I can’t stand is the paperwork. Peter De Vries M any employed writers dream about the freelance life—skipping the commute to the office, wearing pajamas all day (or nothing at all), being their own boss, and working their own hours. Many freelance writers long for the corporate life—a steady income, paid vacations and sick days, health insurance, retirement plans, company parties, and talkative coworkers. Many other writers, however, are happy with their work lifestyle, be it employee or freelancer. What about you? What path should you take? It all may come down to your personality. Read the following statements and see which category best describes you. 28 Becoming a Medical Writer 29 I can be a freelance medical writer because: • I have the experience and contacts to attract clients • I can tolerate risk • I know what it costs to run my own business • I have administrative skills (or my spouse does!) • I know how to market myself and my services • I don’t have major financial needs • I have savings or passive income that will support me for at least six months Or, I’d rather work for a company because: • I prefer the financial security of a paycheck • I cannot tolerate much risk (for example, I am in debt) • I like to be around people • I want to stay and grow in one company, eventually ascending to management • I need sponsored health insurance and other benefits If the descriptions above did not help much, perhaps the following illustration will. In the first edition (1996) of his book Careers for Writers, Robert W. Bly tells this story: “When I went freelance in February, 1982, I had very little money, but also very few expenses or responsibilities: I lived in a one-room apartment, didn’t have a family to support, and didn’t own a car. I was only twenty-four years old, with no one dependent on me.” 30 Becoming a Medical Writer By 1996, Bly had a wife, two young children, a house mortgage, two cars, and had to save for retirement and college for his children. “I often wonder if I would make the leap from corporate employment to freelance employment today as readily and easily as I did in 1982,” Bly wrote. “I think I would not: I am not a risk taker, and I would be afraid of losing the security and income of a corporate job.” Perhaps you have some of the things needed to be a freelance medical writer but lack others. Well, don’t worry. If you desire a freelance career, set that as your goal. Many medical writers work at a company for several years before jumping into freelancing. Those years in the corporate world confer them credibility, experience, and contacts. “You need to work inside industry for a while before you go out on your own,” says Lanie Adamson, who worked at a pharmaceutical company for 14 years and is now a freelance writer. “You have to get to know what the companies need and what the products are like. Inside a company you get to know how a product comes through research and development and then how it is marketed. Then [as a freelancer] you can serve those companies.” CHAPTER 5 Should I Focus on Clinical or Consumer Health Writing? The cardinal sin in medical writing is not grammatical error but obscurity. Stanley Gilder I ’ve always found clinical writing a bit boring. Of course, my fellow clinical writers will disagree with me. They say that consumer health writing is too light. It’s all a matter of personal interest and, in part, background. I prefer writing for a lay audience because of my journalism background and because of the challenge of translating technical concepts into simpler language. But clinical writer Sherri Bowen thinks differently. “I love being a good regulatory writer, following prescribed agency guidelines and formulas, without the agony of writing fiction or spin,” she says. “Over the years, I have developed a great deal of skill in interpreting clinical data and the ability to write about it clearly and concisely. In my own small way, I know I am helping people by bringing important drugs to 31 32 Becoming a Medical Writer the market. I have learned so much about so many different topics in science and medicine—really fascinating!” While clinical writing is detailed and complex, consumer health writing is lively and sometimes sketchy. The backbone of clinical writing is data; the center of consumer health writing is story. Despite the differences, you can find clinical writers who tell fascinating stories of drug development in their clinical reports, and consumer health writers who delve into hard science in their articles. No matter what path you take, or who you write for, a passion for medicine and writing is indispensable. Freelance medical writer Cindy W. Hamilton says she loves the level of intellectual challenge her job provides. “I love to work with people who are very excited about their research, passionate about the science. Let’s face it, if people want to write about something is because it’s new and exciting and that really adds to my day-to-day job—to know I’m going to make a difference.” Further in this book I describe clinical and consumer health writing in more detail and offer some tips on how to break into them. Becoming a Medical Writer 33 “Few writers could equal the feat of Watson and Crick, who described the double helix (the molecular structure of nucleic acids) in 900 words, one table, and six references. Arthur Kornberg reported on the enzymatic synthesis of DNA in 430 words. Cournand and Ranges reported on the first catheterization of the human heart in 950 words. Fritz A. Lipmann described coenzyme A in 250 words, one table, and five references.” Edith Schwager, in Medical English Usage and Abusage Writing for the Pharmaceutical Industry CHAPTER 6 An Overview of the Industry M ost medical writers work for or contract their services to the pharmaceutical industry. This section describes the types of writing you would likely do for pharmaceutical and similar companies. Each type of writing requires a special set of skills and background. For example, post-docs who have a passion for writing are very desirable in medical writing because they understand the science and probably have already published in medical journals. Let’s start with some definitions to better understand the pharmaceutical industry. Pharmaceutical companies research, develop, market, and/or distribute drugs. Some of the major pharmaceutical companies (a.k.a. Big Pharma) in the world are Pfizer, Bristol-Myers Squibb, GlaxoSmithKline, and Sanofi Aventis (see a larger list here). Biotechnology companies may also produce drugs but use derivatives of biological systems or living organisms. The leading biotech companies are Genentech, Amgen, and Genzyme (see a larger list here). 35 36 Becoming a Medical Writer Contract Research Organizations (CRO) are independent contractors that offer their services to pharmaceutical companies—the services include product development and formulation, clinical trial management, data management, preparation of regulatory documents, and more (see a list of CROs here). Medical Device Companies develop instruments or machines intended to diagnose disease or other conditions, or cure, mitigate, treat, or prevent a disease. Examples of devices include cardiac implants, infusion pumps, and elastic bandages. Top medical device companies include Boston Scientific and GE Healthcare . For more information about the medical device industry visit the Medical Device & Diagnostic Industry Web site. Medical Communications Agencies provide marketing and public relations support to pharmaceutical and medical device companies, targeting both health care professionals and consumers. Some medical communications agencies are Pascale Communications, Rete Biomedica, and Complete Healthcare Communications Inc. 37 Becoming a Medical Writer Companies in ‘FORTUNE’S 100 Best companies to work for’ (2007) that hire medical writers. Ranking Company Industry Headquarters 2 Genentech Biotechnology San Francisco 9 Methodist Hospital System Health care Houston 21 Griffin Hospital Health care Derby (CT) 23 Vision Service Plan Health plans Rancho Cordova (CA) 35 Children’s Healthcare of Atlanta Health care Atlanta 37 Northwest Community Hosp. Health care Arlington Heights ( IL) 40 Amgen Biotechnology Thousand Oaks (CA) 43 Genzyme Biotechnology Framingham (MA) 52 OhioHealth Health care Columbus 54 Baptist Health Care Health care Pensacola (FL) 62 Mayo Clinic Health care Rochester (MN) 65 Alcon Laboratories Pharmaceuticals Fort Worth (TX) 71 AstraZeneca Pharmaceuticals Wilmington (DE) 72 Medtronic Medical devices Minneapolis (MN) 80 Lehigh Valley Hospital Health care Allentown (PA) CHAPTER 7 Regulatory Writing Preferred background: Pharmacy, medicine, science; also English T he Food and Drug Administration (FDA) regulates the pharmaceutical industry in the United States. The FDA has five centers, which are responsible for prescription and over-the-counter drugs, medical and radiological devices, food and cosmetics, biological products, and veterinary drugs. The FDA’s Center for Drug Evaluation and Research (CDER) evaluates the safety and efficacy of new drugs before they go on the market. But CDER does not conduct testing of drugs—that is the responsibility of the pharmaceutical company which develops the product. The company tests the drug in animals and humans and then submits documents with evidence of its safety and effectiveness. Scientists at the FDA then review the documents submitted. As a regulatory writer, possible documents you would write include clinical study reports, investigator brochures (manuals on conducting a clinical trial), and regulatory 38 Becoming a Medical Writer 39 submissions (INDs, NDAs, CTDs, MAAs). These are defined below. • Investigational New Drug Application (IND)—the company requests permission to test a drug in humans. The IND includes scientific information about the chemical composition of the drug, an overview of previous animal studies, and whether the drug has been used in humans overseas. If the drug has been tested overseas, a complete summary of all efficacy and safety information to date also needs to be submitted. • New Drug Application (NDA)—the company has completed its research in humans and now submits the results in the NDA. This comprehensive document contains data on the effectiveness and safety of the drug obtained during preclinical and clinical trials. • Common Technical Document (CTD)— in the early 1990s, regulatory authorities and experts from the pharmaceutical industry from Europe, Japan, and the United States created the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH seeks to harmonize the interpretation and application of technical guidelines and requirements for product registration to avoid the duplication during the development of drugs in every region. As a result of this harmonization 40 Becoming a Medical Writer came the CTD, which includes information on how the product is administered and prescribed and other documentation on the drug’s quality, safety, and efficacy. The CTD was designed for use in Europe, Japan, and the United States. For more details about the CTD visit the ICH Web site. • Marketing Authorization Application (MAA)—the company submits an application requesting marketing authorization of the drug in the European Community, which includes chemical and clinical data on the drug. For more information, I suggest you read the article The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective. While CDER regulates drugs, medical devices are the responsibility of another FDA center. The FDA’s Center for Devices and Radiological Health (CDRH) regulates companies that manufacture, repackage, relabel, and/or import medical devices sold in the United States—in addition to radiation-emitting electronic products such as lasers, x-ray systems, and ultrasound equipment. A good overview of the regulatory requirements for medical devices is available at the FDA’s site. A third FDA center you may write documents for is the Center for Biologics Evaluation and Research (CBER), which is responsible for blood products, vaccines, human tissue, Becoming a Medical Writer 41 allergenic materials and antitoxins, and biotechnology products. For instance, once an IND for a vaccine is approved, a company will submit a Biologics License Application (BLA) to CBER. For more information visit this site. As a regulatory writer you should have good knowledge of clinical study design and conduct; how to write protocols and how to read and interpret clinical data (summary tables and listings). You should also be aware of case report form design, good clinical practice (GCP) regulations and regulatory document guidelines such as the ICH. The Regulatory Affairs Professional Society (RAPS) offers online courses and books on regulatory issues, although they tend to be expensive. AMWA and DIA also offer workshops targeted to regulatory writers. Because of the complexity and technical details of regulatory documents, companies prefer to hire writers with a medical background. “Our experience is that you need to be a good scientist first, preferably with a degree in the health sciences (pharmacist, pharmacologist, nurse) and then hopefully have a talent for writing,” says Larry Liberti, an experienced regulatory writer who now works for Thomson Scientific. “The latter can be developed but it is rare to be able to train someone in the health sciences on the job.” 42 Becoming a Medical Writer According to Liberti, in a support services company such as Thomson Scientific, salaries are based on degree and years of experience and “range from $60,000 for a starter to $95,000 for a senior writer (no management responsibilities).” Charlene Tucker, Sr. Director of Regulatory Medical Writing at Cephalon, Inc. says that the best place to start for someone with little writing or pharmaceutical experience is with a Contract Research Organization (CRO). “CROs, if they offer a medical writing function, are often hired by pharmaceutical companies to write individual patient narratives needed for clinical study reports. This is perfect job for a “junior” writer.” Becoming a Medical Writer 43 “I’ve worked as a nurse (15 years), clinical research coordinator (5 years), consultant, writing SOPs for Pharma companies (2 years), then medical writing (7 years and counting). The latter is the best job I’ve ever had, as it draws on so many different parts of me. I was in the right place at the right time at so many points in my life. I could chalk it up to luck, but I also remind myself of Pasteur’s observation: “Chance favors the prepared mind.” If you are considering a career in medical writing, don’t be afraid to take a risk. Try it, you might like it!” Becky Hansen Regulatory writer, MGI PHARMA CHAPTER 8 Medical Marketing Communications Preferred background: English, Journalism, Public Relations M edical companies and organizations must promote their products and services to reach the public. As a medical marketing writer in a drug company you would write copy for ads that promote drugs in easy-to-understand language for the consumers—indications for use, pros and cons, side effects, and interactions. You would also develop educational material for health care professionals about the same drugs but in more technical terms—efficacy, side effects, and other considerations. In a different setting, let’s say working at a hospital, you would write informational articles about diseases/conditions to be published in newsletters, Web sites, magazine articles, brochures, CD-ROMs, manuals, and direct mail. Besides hospitals, other organizations that require marketing medical writing services are: • Associations • Clinical practices • Foundations 44 Becoming a Medical Writer 45 • Medical publishers • Medical schools • Patient advocacy groups • Government (all levels) A third source of medical marketing communications is, of course, a medical communications agency. As mentioned before, medical communications agencies provide marketing services to pharmaceutical companies. According to Erin Caffrey, director at Pascale Communications, these medical communications agencies: • Run programs to educate medical professionals about procedures and treatments • Ghostwrite manuscripts for submission to peer-reviewed journals • Develop and pitch compelling stories to trade publications to address key messages • Plan and develop the agenda for advisory board meetings • Develop content for presentations by physicians • Write abstracts for submission to major medical meetings As a medical writer in a medical communications agency, you would ghostwrite materials for clients—that is, they will be identified as the authors, not you. These materials include abstracts, manuscripts, slides, or trade journal articles. 46 Becoming a Medical Writer Caffrey says that Pascale posts positions for new account executives (medical writers, for example) as they garner new clients. “The skills we often seek are established project management, writing and interview abilities, and a desire to work in a technical field,” Caffrey says. “Public relations or journalism/writing experience is greatly desired. It is not common to find a candidate who already has the technological background. As such, we feel that the ability to manage accounts, interview, and write will provide the foundation on which to build the technical expertise. Generally, we’ve seen our employees gather this technical prowess within 2-4 months of starting here.” Medical writer Lori de Milto says that if you want to break into marketing medical writing you should do “anything” to get good writing samples. For example, writing a newsletter for a volunteer group or writing a health article for a small, local newspaper. “Stay focused and actively look for opportunities. Marketing medical writing is a terrific field with many opportunities, but it takes time for each writer to find the right path (work he/she likes and is good at),” de Milto says. Becoming a Medical Writer 47 “I graduated from college with a degree in English and intentions to do some sort of writing, but really had no idea what direction I would go. I took a job at a nonprofit and put together their newsletter, but wanted more. Finally, in 2002, I applied for a job as a medical/business writer for a small communications company based in Phoenix, where I was living. I submitted samples from my newsletter writing, as well as clippings from my college newspaper, where I was Editor-in-Chief. They must have seen something good in my resume and I took a writing test. This was probably the hardest thing I ever did! I had no clue! But, as I have learned, if you are a good enough writer, you can write on just about any topic. I’ve been at my job for more than four years and love medical writing! I am even on my way to becoming a certified medical writer through AMWA!” Patrice La Vigne Medical Writer, VerusMed CHAPTER 9 Medical Education Preferred background: Science, medicine M any states require physicians to earn educational credits every year to maintain their professional li- cense. These credits are earned through continuing medical education (CME) courses. Writing the content of CME courses for health care professionals is a lucrative opportunity for medical writers. The purpose of CME courses or materials is to update the medical community with the latest information on medical treatment, patient care, and other topics. CME content is delivered in many different formats, from self-study guides and monographs about a particular disease to multimedia presentations and educational videos. Medical education is also directed to patients, who need accurate and reliable information to make decisions about their health. As a writer in this field, you would write patient education materials such as brochures explaining how to take a medication or how to cope with a disease, Web site articles, and video scripts. Some medical communications agencies specialize in 48 Becoming a Medical Writer 49 producing CME and patient education materials and they usually have medical writers on staff. You may also do this kind of writing at universities or medical schools, which often have a CME office. In an interview for the AMWA Journal (Vol. 21, No. 4, 2006), Eve Wilson, Director of Continuing Medical Education at INNOVIA Education Institute said that the best medical writers in her CME group are those who love to learn and are eternally curious about medicine and science. What qualifications and skills does she look for in new CME writers? “I weigh the quality of writing samples and/or writing tests very heavily—in my opinion, medical writing should be precise, succinct, clear, as free of jargon as possible, and accurate,” Wilson says. “In the CME world, we also tend to look for expertise in specific therapeutic areas (say cardiology or neurology) that fit the areas we do our work in. Experience in multiple therapeutic areas is always a plus. Experience in CME per se is not necessarily critical, but experience in education would be a real asset.” CHAPTER 10 Technical Documentation Preferred background: English, Technical Communication M edical devices come along with instructions on how to use them; medical diagnostic equipment includes user guides and reference manuals. These documents are called technical documentation. As a medical technical writer you would write manuals for medical equipment, software, and services using the information provided by the engineers, programmers, or other experts who developed them. What makes a good technical writer? • A good technical writer “translates” the specialized language of the engineers and programmers into a language that nonspecialists can understand. • A good technical writer understands the needs and background of his or her readers. • A good technical writer not only focuses on language but also on the format, design, and order of the information conveyed. Technical writer ranked 13 out of 50 in the 2007 Best Jobs 50 Becoming a Medical Writer 51 in America list by Money magazine. According to Money magazine the average pay for a technical writer is $57,841, but the top potential compensation is $95,538 (5% of technical writers make more than this). If you are interested in this field, you should join the Society for Technical Communication (www.stc.org). STC’s Web site offers valuable resources, including a job database, a membership directory, conference proceedings, specialized publications, and a salary survey. 52 Becoming a Medical Writer “I went straight through college and grad school, earned a Ph.D. in zoology at Indiana University, and worked as a postdoc there doing research in neurocytology. My husband was active in Toastmasters, and at speech contests I met people who worked at the Johnson Space Center (JSC) in Houston. They told me who to talk to about a job in life sciences at JSC. After finding out which sciences were represented at JSC, I didn’t think a neurocytologist would be very employable there, so I decided to look for a job as a technical writer. I had written numerous research proposals, abstracts, and articles, and when I found out about AMWA I joined it. I was hired by a NASA contractor, Northrop Services, in the summer of 1982. In 1987, another contract was consolidated with Northrop’s and the other contractor won it. I have worked for that company, now Wyle Laboratories, for 20 years. My job has included writing articles and presentations for scientists and the public, working on a database of flight experiments, and now full-time technical (and non-technical) editing. I have never looked back, but the best part is that when I was in high school I wanted to be a “space scientist” and work in a government laboratory. I achieved that dream almost accidentally!” Jane Krauhs, PhD, ELS Senior Scientist, Wyle Laboratories CHAPTER 11 Getting the Job: Recruiters, Resumes, and Interviews O ne of the best ways to land a job at pharmaceutical, biotechnology, or medical device companies is to sub- mit your resume to a personnel recruiter such as Placemart Personnel Service (www.placemart.com). Placemart matches people and organizations by identifying, recruiting, and placing candidates in several areas, including medical regulatory writing. According to Bill Kuhl, Principal Recruiter for Placemart, there are many advantages to using a recruiter: • The recruiter will strive for a fair compensation, reconciling the company’s budget with the candidate’s salary expectations. • The recruiter is in direct communication with the hiring manager and key decision makers. • The recruiter generally has knowledge of internal information not included in the published job description. • The recruiter can provide guidance through the extensive sequence of steps in the hiring process. 53 54 Becoming a Medical Writer Recruiters that serve medical writers • Aerotek Scientific • The Bandish Group • Bioforce Solutions • The Cambridge Group • Chiltern Integrated Resourcing Solutions • ClinForce • Kforce Professional Staffing • Medical Staffing Network • Metropolitan Research Associates • Pharmaceutical Careers • SRG Woolf Group Before submitting your resume to a recruiter, be sure it is right on target. What do companies look for in your resume? Managers and human resources people believe that what happened in your past is predictive of what will happen when they hire you. That is why your resume must show that you have been successful at writing something—papers, newsletters, abstracts, reports. Published articles will certainly grab their attention. Remember that you are applying for a medical writing job, so present yourself as a scientist writer, not just as a sci- Becoming a Medical Writer 55 entist. Otherwise they may offer you a position you are not interested in. Below are some tips for a great resume. 1. Demonstrate your writing experience including full and correct citations—complete citations will suggest that you are detail-oriented, which is a necessary quality in medical writers. Include also information about any training in writing such as certificates, courses, or degrees. 2. Demonstrate your medical education and/or experience including details about your therapeutic areas. 3. Make sure that your spelling and presentation are perfect—they say a lot about you. 4. Show your progression from education to professional experience with no gaps—include the month and year for everything you did (beginning and end). As a plus to the information above, you can make your resume even better if you can demonstrate that you have: • An understanding of the clinical research process and domestic and international regulatory requirements • Knowledge of medical style guides and writing templates • Project management skills What if you don’t have much work experience? Perhaps you just graduated from college and are applying for an entry-level position as a medical copywriter. Or perhaps this is 56 Becoming a Medical Writer your first job after graduate school. If that is your case, you can compensate for the lack of professional experience by listing in your resume all courses relevant to the work you would perform at the company—and list any papers and presentations as well. In some cases, the company you are applying to (or the recruiter) may give you a writing/editing test. For example, they would ask you to write the synopses of several scientific articles or to edit a manuscript. However, if you have good writing skills, you should not worry about these tests—you will probably pass them easily. Instead, focus on performing well during the interview. Being called for a face-to-face interview means that the hiring person thinks that you probably have what it takes to do the job. Now, he or she will evaluate whether your personality and behavior fit with the culture of the company. Some tips to remember: • Do your homework before the interview—know the company • Go in with a positive and cheerful attitude • Always maintain eye contact with your interviewer • Answer every question directly and with honesty • Turn off your cell phone! Becoming a Medical Writer 57 The etiquette and advice for any job interview also apply for medical writing jobs. Get more interview tips at Monster.com and Careerbuilder.com. Consumer Health Writing CHAPTER 12 Writing for Consumer Health Magazines and Web Sites H ealth stories make the covers of magazines and newspapers almost every day. From the latest weight loss method to a potential cancer cure, editors are actively seeking story ideas. Freelance medical writers who write health articles for consumer magazines can get as little as $50 for short pieces and as much as $5,000 for feature articles in top magazines. Magazine writing is an art in itself and there are entire books solely on this topic, like the Writer’s Digest Handbook of Magazine Article Writing, edited by Michelle Ruberg. Here’s some useful advice from that book: “... health magazines are extremely niche-oriented, so freelancers must be savvy to each publication’s distinctive slant when pitching article ideas. For example, Health ‘is very much about a healthy lifestyle,’ whereas Let’s Live is ‘all about nutrition,’ and Men’s Health is definitely a guy thing.” 59 60 Becoming a Medical Writer The Handbook of Magazine Article Writing includes tips on how to write query letters (or emails), how to send your manuscripts, and much more. Remember to always follow the publication’s guidelines for contributing authors. Ignoring those simple rules can put your great story idea in the rejection pile. Keep in mind, though, that some health magazines receive dozens of queries every day and most of them are rejected. So be prepared for rejections and keep on querying—the more you query, the greater chance you’ll be published. Web sites that specialize in health topics tend to follow similar guidelines to print magazines when it comes to story ideas. But writing for the Web is certainly different. “It’s easy to just write and write, with no particular reader in mind,” write the authors of The Web Content Style Guide. “The problem with this sort of writing is that nobody reads it. Always keep the reader in mind when writing. Think of them as busy, impatient people who are on the Web to find out something.” When writing for the Web try to make your text clear and concise; use highlighted key words and bulleted lists; and be objective with credible links. Also, ask this about your writing: • Is this clear? • Is there a simpler way to say this? Becoming a Medical Writer 61 • Is there a shorter way to say this? • Is this necessary? We asked ourselves these questions when developing the ‘Immunization Science’ section for the Web site of the National Network for Immunization Information (NNii). ‘Immunization Science’ includes synopses of the latest articles on vaccines and immunizations in the scientific literature. Because we wanted this information to be accessible not only by health professionals but also by parents, we created a special template (click here to see an example), breaking down the information into distinctive headings: • The article—full citation of the article and a link to the original abstract or full text • The question—what the researchers wanted to find • The study—description of the methods of the study • The findings—the results; the answer to the question • The relevance/bottom line—the conclusion of the article • NNii’s comment—an editorial comment on the strengths and limitations of the study</list> As you can see, format is very important when writing for the Web. A ‘Questions and Answers’ format is also a very effective method. For instance, for the NNii site we developed a successful section for parents where we address common concerns about vaccines, using questions and answers. 62 Becoming a Medical Writer One of the world’s authorities in Web usability is Jakob Nielsen. His site has a great section about writing for the Web. CHAPTER 13 Breaking into Consumer Health Writing N ow that you have an idea of how magazine and Web articles are written, let’s look at four simple ways to break into the consumer health market. 1. Write a story based on a medical journal article Most medical journals offer journalists and freelance writers the chance to see embargoed copies of their articles a week before publication. You can obtain these copies (and the journal’s advance table of contents) by subscribing to the journal’s ‘media alerts.’ These media alerts usually include the names and contact information of the articles’ main authors for interviews. Knowing in advance what is going to be published gives you the opportunity to pitch stories to editors even before they hear about the studies. There are hundreds of journals out there, but be sure to subscribe to the alerts for the top publications such as the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA). 63 64 Becoming a Medical Writer You may decide to specialize in an area that interests you or that is familiar. In that case, monitor the journals covering that area. Because I specialize in vaccines and infectious diseases I subscribe to the alerts of Pediatrics, Pediatric Infectious Diseases, Vaccine, Clinical Infectious Diseases, and other related journals. Journal subscriptions can be expensive. That is why you must take advantage of the free online access given to media subscribers. Note, however, that not all journals offer free access to their articles and others will only allow you to see the current issue, not the archives. One way around this is to find a medical library near you that either has a print or an electronic subscription to the journal you need. Before these media alerts became available, medical journalists spent considerable time scanning dozens of journals to find newsworthy articles. Now, journal media offices (or editors) select the articles they think are newsworthy in each issue and feature them in the media alerts. This certainly makes your job easier. Stories based on journal articles will most likely interest publications that carry health and medicine news. Write them in journalistic style, using the inverted pyramid—that is, describe the most important facts first and then offer details. Start off with a clever lead that hooks your readers and invites them to keep reading. Becoming a Medical Writer 65 I have included an example of a story I wrote based on an article published in the journal Archives of Internal Medicine. I decided to write the story because the topic of smoking cessation is of general public interest. The story was published online at AssociatedContent.com—a good site to get publishing samples (and get paid), if you are just starting out. Newly Approved Drug to Quit Smoking Appears Effective: Study Shows Short Term and Long Term Efficacy of Varenicline By Diego Pineda Are you trying to quit smoking? Then you’ll do better taking these new pills than chewing nicotine gum or wearing a skin patch. According to a study published in the August 14/28 issue of the Archives of Internal Medicine, the recently approved (May, 2006) drug varenicline tartrate is more effective than other treatments in helping smokers kick the habit. Current smoking cessation aids—as these drugs are known—fall in one of two categories: nicotine replacement therapies (NRT), such as chewing gum, skin patches, tablets, nasal sprays and inhalers; and non-NRT medications, such as the antidepressant drugs bupropion and nortriptyline. Scientists have tried to develop new smoking cessation aids for two main reasons. One, NRTs carry some known health risks. For example, nicotine patches can have toxic effects if used while still smoking. Two, 66 Becoming a Medical Writer bupropion and nortriptyline are not highly effective—on average, only between 7 and 30% of users are still not smoking after a year. The new drug, varenicline, is a non-NRT that simulates the effect of nicotine in the brain without creating addiction. When nicotine is present, the drug helps suppress some of the reinforcing effects of smoking. In the Archives study, researchers selected 638 healthy adults between 18 and 65 years of age who smoked at least 10 cigarettes per day. They were randomly assigned to one of three different treatment groups: varenicline, bupropion or placebo (usually an inert substance such as a sugar pill). The varenicline group was further divided into one of three dose regimens (0.3 mg once daily, 1.0 mg once daily, or 1.0 mg twice daily). The study participants were treated for seven weeks and were then asked to participate in follow-up counseling (to prevent relapsing into smoking) for up to a year after the beginning of the treatment. The study found that more people taking varenicline (48%) quit smoking than those treated with bupropion (33%) and placebo (17%). The higher the dose of varenicline, the more effective it was. “In this study,” the authors wrote, “varenicline tartrate, 1 milligram twice daily, effectively helped subjects quit smoking, with response rates three times higher than those for placebo while demonstrating a good tolerability profile in this population of smokers who on average had smoked approximately 20 cigarettes per day for approximately 24 years.” Becoming a Medical Writer 67 This is good news for those looking for alternatives to help them kick the smoking habit. Be cautioned, however, that Pfizer Inc., the manufacturer of varenicline, funded the study; independent researchers must confirm these positive results. Varenicline is marketed under the brand name Chantix and requires a doctor’s prescription. According to the Food and Drug Administration (FDA), the approved course of Chantix treatment is 12 weeks. Those who successfully quit smoking during treatment can use it for another 12 weeks to further increase their chances of staying away from the cigarette pack. Side effects include nausea, headache, vomiting, gas, insomnia, abnormal dreams, and change in taste perception. Stories such as the above easily fit in a newspaper or news site, but not so much in a magazine, where you have to query several months in advance. The study, however, may serve as background information for a feature magazine article about smoking cessation aids. 2. Cover a medical conference Many health publications or medical organizations rely on freelancers to cover conferences or specific sessions. I was still in graduate school when I covered my first scientific conference for a magazine. The editor wanted me to write up summaries of a few sessions about scientific publishing, which were of interest to the readers of the magazine. 68 Becoming a Medical Writer Since the program included many other topics, I attended other sessions in search of story ideas. From one of these sessions, for example, I wrote an article about the genetics of obesity for a science Web site. Look for medical conferences being held in your area and pitch editors about covering the event for their publications. But before you send out your queries, make sure that you are knowledgeable on the topic (perhaps you’ll find one that suits your background) and whether the sessions are geared toward a specialized or a mixed audience. If you are not an expert on breast cancer, for example, you’ll benefit more from a session for the general public than one for breast cancer researchers—otherwise the whole talk will be over your head. In any case, remember to do your homework—read as much as you can about the topic and make a list of speakers you would like to interview. If possible, obtain a press pass from the organizers and schedule interviews in advance. 3. Profile the work of academic researchers Universities are gold mines for medical writers, who can dig out valuable stories from research labs. Some years ago, I noticed that a publication specializing in genomics was looking for freelance writers. I was no genomics expert, but I was sure Becoming a Medical Writer 69 I could find one. So I went to the largest university in town and interviewed a real expert. Turns out that this expert was doing some breakthrough research in genomics! On another occasion, I stumbled upon one of the pioneers of modern cloning technology by just asking around for names of renowned professors at that same university. The resulting interview profiled a sharp scientist with a fascinating life story. Building relationships with researchers will reap fruits when you need background information or a good quote for a story. What if you don’t know any experts? Fortunately, there are resources available. You can call the non-profit Media Resource Service (www.mediaresource.org) at (800) 2231730 and they will help you locate (at no charge) an expert to interview for your story. Another useful source for experts is EurekAlert!’s Science Sources: A directory of public information officers. Request a copy of this directory by contacting EurekAlert! (www.eurekalert.org). 4. Write a book review Book reviews in trade journals and consumer magazines are usually assigned. However, if you suggest reviewing a book in an area you are an expert on, editors will usually 70 Becoming a Medical Writer consider your query. According to Barbara Gastel, book review editors tend to appreciate when someone offers to review a book. “Calling their attention to little-publicized but valuable new books can be especially useful. And anything that helps editors expand their pools of qualified, willing, reliable reviewers is likely to be welcome.” (From ‘A strategy for reviewing books for journals,’ BioScience Vol. 41, No. 9, 1991). A good book review should describe the book contents and evaluate its strengths and limitations. Here are some tips for writing a book review: • Describe the stated purpose of the book and whether it was met or not • Provide information about the context of the book—for example, is it about a new treatment or does it follow up on previous works? • Discuss the qualifications and expertise of the author • Note any special features of the book such as illustrations, exercises, or glossaries • Tell who will benefit more from the book—health care professionals or patients? How do you find books to review? Go to Amazon.com and look at the Health and Science sections under ‘New & Future Releases.’ If you don’t want to buy the book or wait for the publication to reimburse you, write to the publisher Becoming a Medical Writer 71 (or the author) and ask for a review copy of the book. The four suggestions in this chapter will help you generate enough writing samples to convince editors to give you larger—and more lucrative—assignments like feature articles and nonfiction books. Other Medical Writing Opportunities CHAPTER 14 Academia, Hospitals, Nonprofits, and More W hat do the American Cancer Society, the Institute of Medicine, and the Centers for Disease Control and Prevention have in common? They all employ medical writers. In fact, many organizations outside the media and industry need medical writers to communicate their activities and interests. Think about your town’s university and its medical school; or the patient advocacy group based in your city. For example, the University of Texas Medical Branch at Galveston, where my organization is based, offers numerous positions for which the skills of medical writers are required: • Science Writer / Editor • Publications Production Manager • Marketing Coordinator • Outreach Representative • Internet Communications Coordinator • Media Relations Coordinator • Coordinator of Marketing and Communications • Editor 73 74 Becoming a Medical Writer • Technical Writer • Editorial Assistant • Informational Writer Because this is a medical school and hospital, people in these positions write about medicine—annual reports, brochures, grants, magazine articles, manuscripts, newsletters, press releases, and Web content. The next chapters will look at two other types of writing you can do as a medical writer: public health and grant writing. CHAPTER 15 Public Health and Policy Writing P ublic health is a fascinating but complex field. Just think about some of the public health challenges in recent years: the AIDS epidemic, the anthrax attacks, or even the recent E. coli contamination of spinach that caused deaths in several states. All these issues create uncertainty and fear in the public. As medical writers we must inform and increase awareness of health issues; influence the attitudes of political and social groups; and even help shape public health policy. I come across many complex public health issues in my area of specialization, vaccines and immunization. One recent concern was the controversy surrounding compulsory vaccination against human papillomavirus (HPV)—the main cause of cervical cancer. In mid-2006, the Advisory Committee on Immunization Practices recommended universal immunization of 1112 year-old girls with the HPV vaccine. By February 2007, more than 20 states had introduced bills to make HPV immunization mandatory for entry to middle school. A controversy erupted. 75 76 Becoming a Medical Writer While conservative groups opposed the mandates, arguing that the vaccine would encourage promiscuity, some health experts argued that mandates were premature, the vaccine being so new. In light of the public’s ignorance about HPV and the cultural barriers to immunizing pre-adolescent girls against a sexually transmitted disease, we decided to write a series of articles about HPV. This was an important public health policy issue that needed to be addressed. Medical writers can write about public health and policy from various positions—working for a federal agency like the Centers for Disease Control and Prevention (CDC) or for a nonprofit organization such as Immunizations for Public Health (i4ph). Understanding the importance of good medical reporting, the CDC foundation instituted the Knight Public Health Journalism Boot Camp, a six-day seminar for working journalists interested in the science and issues of public health. This is a description of the Boot Camp from a promotional brochure: “Held on CDC’s campus in Atlanta, scientists discuss the latest findings on dozens of topics, including bioterrorism, vaccine development, genetic links to disease and the prevention of chronic illness. Participants gain skills to help them analyze health risks, evaluate the im- Becoming a Medical Writer 77 portance of clinical studies, and improve their reporting on a wide range of public health issues. “Approximately 15 journalists are selected to participate each year. Preference will be given to working journalists who have at least five years experience and cover health, science or the environment for general audiences. Each journalist will receive an allowance for housing and food. “Our programs are ideal for mid-career journalists who are looking for a way to deepen their understanding of public health reporting. A number of our participants are transitioning to medical reporting and seek our programs to give them a solid foundation and immediate credibility. You’ll find all of the information you need at: www.cdcfoundation.org/knight.” Public health and policy writing can be very rewarding. You could find a cause you are passionate about—AIDS prevention, health disparities, you name it—and make a difference through your writing. CHAPTER 16 Grant Writing and Editing R esearch institutions, universities, and nonprofit organizations need money. Medical writers help them obtain money by writing or crafting grant proposals that are submitted to the government (the National Institutes of Health, for example), private foundations (such as the Robert Wood Johnson foundation), or other organizations (such as the American Heart Association). Depending on the amount of funding requested and the agency, a grant proposal can be a couple of pages long or may require 10 pages or more. In a nutshell, a grant proposal must say: • Who you are • What you need • Why you need it • How much money you need and how and when will you spend it • Expectations and evaluation of the project Learning how to write grants is not difficult. A web search on “grant writing courses” will prompt more than seven million results. Local colleges, communication companies, and 78 Becoming a Medical Writer 79 large universities among others offer these courses. AMWA also offers grant writing/editing workshops during its annual conference. Good grant writing is a craft, often called grantsmanship—the use of strategic elements to write and present a proposal. Some of these elements are: • Understanding what the funding organization or agency is looking for—what are the guidelines? • Understanding the review process—who are the reviewers and what are their expectations? • Making the best use of the limited space—what information and facts will make the case better? Although some medical writers may write grants in their entirety, a team of scientists, writers, and editors usually develops grants. Oftentimes, the role of the medical writer is limited to editing and improving what the principal investigator—who has the knowledge and interest in the topic—has written. Karen Klein, Assistant Director of Grant and Publication Development at Wake Forest University, says that scientists are sometimes so involved in the details of their work that it’s hard for them to step back and ask the most important questions about their grant proposal. That’s where a medical writer can help. “A lot of it is common sense,” Klein says, “trying to put 80 Becoming a Medical Writer yourself in the shoes of the reviewer reading the grant. What do I think they would want to take away from the grant if they are only going to read a few pages? What are the most important parts of the grant? How can we be convincing within these limitations?” According to Klein you should “get your feet wet with volunteer organizations that have a need for grant writing or want advice about grants. This would be a good way to learn what it’s like, to learn how to do it, how the various parts fit together, and, in some cases, working with the funder to make the project happen.” Klein also says that confidence is a very important aspect of writing grants. “When you are insecure, you tend to focus on the flaws, but the idea is to focus on the positive. Practice really helps with that. The more you do it, the easier it is to put your best foot forward.” Becoming a Medical Writer 81 “When I submitted my first grant for NIH funding to do research, I asked the chairperson in my department what he thought about the grant and he looked at me and hesitated for a moment. Then he said, ‘it’s really well written from an English standpoint.’ That’s all he said to me. So that’s when I knew I was probably a better writer than a scientist. “I really enjoyed writing manuscripts, posters, and slides, whereas most of my colleagues couldn’t stand to write or do anything remotely associated with writing. I always found it fun to figure out how to make science sound better or at least more understandable.” Clifford S. Mintz, Ph.D. Medical writer Working as a Freelance Medical Writer CHAPTER 17 The Freelance Path I t is said that good marketing is all about building relationships; so it is with freelancing. Medical writer and editor Jude Richard began freelanc- ing in 1991 as a sideline to his regular job at MD Anderson Cancer Center (MDACC) in Houston, Texas. “I have been very lucky,” Richard says. “Many of my clients found me either by being referred or approaching me directly. I have never really scrambled to find clients. At MDACC, I began a freelance relationship that is now entering its 12th year with a research fellow who was going home to Europe after a 1-year fellowship and needed someone to edit his future manuscripts for correct English.” The relationships Richard built with his clients allowed him to leave his job and become a full-time freelance writer. While Richard works mostly with medical manuscripts, there are many opportunities for freelance medical writers. You can specialize in one type of writing or you can work with different types of projects such as: • Abstracts • Brochures, flyers 83 84 Becoming a Medical Writer • Clinical Reports • Continuing education materials • Grants • Medical manuscripts • Newsletters • Patient education materials • Scientific posters • Web content Are you ready for business? You must realize that as a freelance writer you are self-employed. That means you will need to: • Develop a business plan • Come up with a name for your company • Buy office equipment and supplies • Pay for your health insurance • Deal with legal and accounting issues related to your business • Attend meetings without compensation • The list goes on... There are many books on how to set up a freelance business. One of my favorites is Michael Meanwell’s The Wealthy Writer: How to Earn a Six-Figure Income as a Freelance Writer (Writer’s Digest Books, 2004). I think the first thing you need to do is write down your Becoming a Medical Writer 85 target annual income— $30,000, $100,000? Then calculate your fixed expenses like social security, taxes, insurance, retirement account, and office supplies. Once this is done, you must decide how much you will charge your clients in order to achieve your target income. That is the next chapter’s topic. 86 Becoming a Medical Writer “I became a medical writer through the scientific path. I earned my PhD in neuroscience but realized I didn’t want to work in a lab anymore. But, I loved science. So I wrote a lot in grad school. I worked as a protocol writer after I finished grad school. After I had my son, I started my own company. “I write all sorts of things—journal publications, clinical trial protocols and informed consents, patient newsletters, review articles. I love being involved in science without actually having to do it. I love the flexibility of owning my own company, especially when I have 2 small children. However, I am only working part-time now and will do so for the next few years at least. There are some disadvantages to owning a company though. You are always responsible for delivering the product regardless of what is going on in your life.” Jennifer Newcomb Fernandez, Ph.D. Newcomb Scientific, LLC CHAPTER 18 How Much Should I Charge? I n my experience, fees are dependent on the writer’s experience and the client’s budget,” says freelance medical writer Sherri Bowen. “The market plays a part (academic markets pay much less than Pharma markets), but how much a writer needs the work can also play a part.” Bowen says her usual rate is $95/hour. So, how much should you charge? Your rates will depend on several factors: • The type of client—you can charge higher rates to large for-profit companies than to a small business or a nonprofit organization. Also, bear in mind that companies in the East and West coasts are willing to pay more than companies in the Midwest. • The type of work—usually you can charge more for projects that require research and writing than just editing or proofreading. You may also decide to charge higher rates for more technical and complex projects. • The duration of the assignment—you can offer discounts for projects that last weeks or months (between 10 and 20 percent of your daily or weekly rate) as opposed 87 88 Becoming a Medical Writer to short-duration projects. As Michael Meanwell says in the Wealthy Writer, your rate will also depend on your speed and skills as a writer: “A slow writer may have a low hourly rate, which would appeal to a client until they get the bill. A faster writer may operate at a premium rate but complete the task in half the time, making him or her cheaper and quicker, which is why you need to talk in terms of the bottom line—the overall cost of the project and the overall benefits to the client.” Beginner medical writers often have trouble keeping track of the hours they spend on a project and thus come up with inaccurate estimates for their clients. Take into account that you cannot charge for every hour you work in the week because you take time to do other things like checking emails, paying bills, and so forth. For example, even if you spend five days on a project, you would not charge the “standard” forty hours but the actual time you spent on the project. Jude Richard says he tracks the hours as he uses them. “I count any hours used actually editing, performing literature searches, or doing background research.” You can track your hours using a: • Notebook • Excel spreadsheet • Time tracking software (Google ‘freelance time track- Becoming a Medical Writer 89 ing’ and you’ll find both freeware and shareware/proprietary software) You can also tally hours on the document you are working on, but remember to delete them before sending the document back to the client. Should you charge flat rates? Richard says he rarely does. “I may charge a flat rate for a cash-strapped author [such as] a grad student who needs a thesis lightly edited.” 90 Becoming a Medical Writer Typical Freelance Rates (Low-High) Sources: Writer’s Market 2007 and personal interviews Medical writing $30-$180 per hour Medical editing $30-$125 per hour Medical proofreading $18-$125 per hour Technical editing $33-$100 per hour Technical writing $30-$125 per hour Web page writing $30-$150 per hour Web page editing $32-$100 per hour White papers $45-$135 per hour Educational grant and Proposal writing $35-$100 per hour Regulatory writing $85-$125 per hour Medical marketing $30-$150 per hour Manuscript writing for scholarly journals $40-$125 per hour Consumer magazine feature articles $0.14-$3 per word Trade journal feature articles $0.17-$3 per word CHAPTER 19 Attracting Clients T he secret to freelance success is a steady pool of clients who will keep you busy—but not swamped. Below are some tips to promote yourself and fish for some clients. 1. Build a Web site and add a portfolio with writing samples I have been designing and developing Web sites since 1998 and can say with absolute certainty that now, more than ever before, anyone can build his or her own site in a couple of hours. I am not talking about large-scale, multilevel Web sites that take months, but what I call “brochure sites.” These are simple sites with a home page and 2-4 sub pages. See for example my brochure Web site diegopineda.com. Because I did not want to spend a lot of time on such a small site, I used a template from another designer and adapted the graphics and page names to my needs. To create your personal brochure site and online portfolio, do the following: 1. Grab pen and paper and draw a site map, using rectangles for each page of your site (you may also use the organizational chart feature in Power Point) and write 91 92 Becoming a Medical Writer the names of the pages in the rectangles. This will be your site’s blueprint. 2. Write the content for each page in a word processor. 3. Collect writing samples and turn them into PDF files. If you don’t have the full version of Adobe Acrobat, go to createpdf.adobe.com. There you can create five PDFs for free, or buy a subscription if you need more. 4. Buy a domain name (either your name or your company’s) and contract hosting. I recommend Doteasy.com (their domains are more expensive than others but you can get free hosting, which is a better deal in the end) or 1and1.com. They have several hosting plans, but for a brochure site, a basic plan will suffice. 5. Design and publish your site. Doteasy and 1and1 have easy-to-use online site builders that will guide you step by step on how to build a basic site. Alternatively, you can hire someone to do all this work for a fair price. I offer Web design services. Contact me at dpineda@amwasouthwest.org and I can give you an estimate. Becoming a Medical Writer 93 2. Actively look for writing opportunities at professional network sites Web sites such as Elance.com, Guru.com, and Suite 101 allow writers to bid for writing projects posted by employers. Although the specifics for each site may vary, this is how they generally work: 1. You open a “service provider” account under the Writing category and create your profile. Membership costs vary, depending on how often you want to bid and the payment plan you choose. 2. You then search the projects posted and bid on the ones that you are interested in. 3. If you are selected for a project you will agree on the terms with your client and deliver your work. 4. Once the project is delivered, the client will send payment through the site’s system (which takes out a commission) and provide feedback. The ratings from your client’s evaluation will be available for prospect clients to see and may impact (positively or negatively) your future bids. One disadvantage of these services is the fierce competition. Hundreds of writers from all over the world (especially India) bid on the projects, even offering very low hourly rates that we cannot afford in the United States. You may find it hard to break in if you charge higher rates, but if you suc- 94 Becoming a Medical Writer ceed in one or more of these sites, you will probably never lack clients. 3. Join AMWA and list your services in their Freelance Directory AMWA members can place a listing/resume in the Freelance Directory for $75 per year. The listing contains your contact information and a description of your services with area of expertise. The AMWA site recommends: “List your areas of expertise because many subscribers begin their search with keywords such as immunology, biology, liver disease, clinical medicine, and cardiology. You may list books and periodicals to which you have contributed, and you may also describe relevant positions and specific accomplishments.” AMWA members can search the listing for free. Nonmember individuals and organizations who wish to search the directory to hire a freelance writer must purchase a subscription. 4. Subscribe to Writer’s Market Every year, a new edition of Writer’s Market hits the bookstores. It has been called the “freelance writer’s bible,” because it provides the contact information of thousands of editors and agents in the United States and Canada—and a few listings from the United Kingdom and Australia. Becoming a Medical Writer 95 In my opinion, the online version (www.writersmarket. com) is better. For $29.99 per year or $3.99 per month, you get access to a searchable database that can be personalized to look for medical and health writing opportunities. Plus, “you also get daily market spotlights, a guide to Web resources for writers, tips on getting published, news from the publishing world, our online submission-tracking tools, and more.” Writer’s Market can be very useful if you plan to write for consumer health magazines and Web sites (or even publish a book), but it won’t guide you to clients in academia or industry. As an alternative, consult the listing of health magazine editors that comes as a bonus when you buy this book. Once you have worked with several clients—and you are sure they were satisfied with your work—ask them for referrals. Nothing beats word of mouth as a means of promotion—credible and free! One last word of advice: If you are struggling to find clients, maybe it is time to diversify your markets and work on different types of projects. Perhaps you are focused on writing; try editing. APPENDIX A Professional Organizations for Medical Writers and Editors T he following is a list of professional groups that welcome medical writers and editors. They offer network- ing, educational, and career-advancement opportunities. I have included a description of each organization’s mission (taken from their Web sites) so you can decide which to research further. American Medical Writers Association (AMWA) www.amwa.org AMWA is the leading international professional association for communicators of medical information. The association offers continuing education, including distance learning; networking opportunities through an annual conference and chapter activities; Web site services, including job listings and a members’ freelance directory; and the AMWA Journal. 96 Becoming a Medical Writer 97 Members work for pharmaceutical companies, universities and medical schools, hospitals, nonprofit organizations, government agencies, journals, and many other businesses and organizations. Many work as freelance writers and editors. Association of Health Care Journalists (AHCJ) www.ahcj.umn.edu The Association of Health Care Journalists is an independent, nonprofit organization dedicated to advancing public understanding of health care issues. Its mission is to improve the quality, accuracy, and visibility of health care reporting, writing, and editing. Eligibility for active membership is limited to: • individuals currently employed by editorially independent newspapers, news services, online services, syndicates, magazines, television or radio stations or networks; • teachers of journalism at the university or college level; and • independent journalists engaged in research or publishing in the field of health care. American Society of Journalists and Authors (ASJA) www.asja.org ASJA is the nation’s leading organization of independent 98 Becoming a Medical Writer nonfiction writers. Its membership consists of more than 1,100 freelance writers of magazine articles, trade books, and many other forms of nonfiction writing. Council of Science Editors (CSE) www.councilscienceeditors.org CSE’s mission is to promote excellence in the communication of scientific information. CSE’s purpose is to serve members in the scientific, scientific publishing, and information science communities by fostering networking, education, discussion, and exchange and to be an authoritative resource on current and emerging issues in the communication of scientific information. Member titles include: Editor-in-Chief, Associate Editor, Section Editor, Managing Editor, Copyeditor, Production Editor, Technical Editor, Publisher, Author, Author’s Editor, Freelancer, Science Writer, Indexer, Abstractor, Information Specialist, Science Librarian, Graphic Designer, Marketing Specialist, Publishing Systems Operator, Typesetter, Printer, and Electronic Publishing Specialist. Drug Information Association (DIA) www.diahome.org DIA is a professional association of approximately 20,000 members worldwide who are involved in the discovery, de- Becoming a Medical Writer 99 velopment, regulation, surveillance, or marketing of pharmaceuticals or related products. DIA is a nonprofit, multidisciplinary, neutral forum for sharing information that optimizes the process of drug development and lifecycle management by providing: • Global and regional forums for the exchange of information, education, and training; • Extensive multidisciplinary networking opportunities; • Rewarding volunteer leadership experiences; and • High-quality professional development opportunities. Editorial Freelancers Association (EFA) www.the-efa.org EFA was formed to provide the means of developing and implementing programs of benefit to professional editorial freelancers and the publishing industry, and to support and advance the interests of both. EFA members are editors, writers, indexers, proofreaders, researchers, desktop publishers, and translators. The European Medical Writers Association (EMWA) www.emwa.org EMWA seeks to provide a forum to promote standards of excellence in medical writing by furthering the professional development of members and increasing awareness of medi- 100 Becoming a Medical Writer cal writing throughout Europe. EMWA has over 550 members from 24 countries (including 7 countries outside Europe), and includes academics and professionals working in-house or freelance for pharmaceutical and medical communications companies, research institutes, and in the field of scientific journalism. Health Academy, Public Relations Society of America www.healthacademy.prsa.org The Health Academy seeks to enhance the quality and stature of health care public relations. Its members represent a variety of health care-related organizations including hospitals, health systems, academic medical centers, pharmaceutical companies, public relations agencies, device manufacturers, biotech companies, medical and dental associations, health plans, managed care organizations, insurance companies, long-term rehabilitation facilities, alternative and complementary health organizations, health education and research organizations, foundations, and government health units. Health and Science Communications Association (HeSCA) www.hesca.org HeSCA is an association of communications professionals committed to sharing knowledge and resources in the health Becoming a Medical Writer 101 and science arenas. Members include producers, graphic designers, medical illustrators, photographers, videographers, instructional designers, multimedia designers, computer animators, librarians, learning resource center managers, educators, writers, trainers, publishers, distributors, health care practitioners, and market specialists in academic, hospital-based, government, non-profit, and corporate environments. International Society of Medical Publication Professionals (ISMMP) www.ismpp.org ISMPP’s mission is to support medical publication professionals through education in fields associated with publication development and planning. The Society strives to promote excellence in publishing effectiveness via open exchange and debate of relevant issues, as well as dissemination of practical information through high-quality conferences and training programs. The Society serves medical publishing professional’s interest by the following means: • Providing a forum to facilitate the further development and awareness of best practices in publication planning and execution • Facilitating and encouraging communications among 102 Becoming a Medical Writer publication professionals within the pharmaceutical industry, medical publishers, medical communications companies, and other research, regulatory, and educational groups • Fostering consensus for policies related to publication planning and medical publishing • Supporting career growth, training and the development of individuals involved in publication development and planning National Association of Science Writers (NASW) www.nasw.org The mission of NASW is to foster the dissemination of accurate information regarding science through all media normally devoted to informing the public. Over the years, its officers have included both freelancers and employees of most of the major newspapers, wire services, magazines, and broadcast outlets in the country. It also welcomes members who are the public information officers on science from government labs, universities, and other institutions. Today, NASW is the largest organization for science writers, with more than 2,400 members. Becoming a Medical Writer 103 National Writers Union (NWU) www.nwu.org NWU is the trade union for freelance and contract writers: journalists, book authors, business and technical writers, web content providers, and poets. With the combined strength of 3,500 members in 17 local chapters nationwide, and with the support of the United Automobile Workers (UAW), the union works to defend the rights and improve the economic and working conditions of all writers. Plain Language Association International (PLAIN) www.plainlanguagenetwork.org PLAIN is a growing volunteer nonprofit organization of plain-language advocates, professionals, and organizations committed to plain language. PLAIN’s objectives are: • To promote the interests of plain-language professionals. • To promote standards and practices of the plain-language profession. • To promote research and development in plain language. • To provide marketing and networking services for our members. • To help people understand and use plain-language principles. 104 Becoming a Medical Writer Members include professionals who plan, write, design, and create communications projects to better serve the needs of the public, clients, customers, students, and staff. They work as authors, communications specialists, consultants, designers, editors, managers, professors, trainers and writers in business, education, government, health, law, medicine and social service. Regulatory Affairs Professionals Society (RAPS) www.raps.org RAPS is the leading worldwide member organization devoted to the health product regulatory profession. With more than 10,000 individual members from industry, government, research, clinical, and academic organizations in more than 50 countries, RAPS develops professional standards for knowledge, competency, and ethics and is the leading source of information on the scope of practice of regulatory professionals and their critical roles in the health sector. Members are engaged in the regulatory process or in related scientific, clinical, or engineering areas involved in the health product life cycle. Becoming a Medical Writer 105 Society for Scholarly Publishing (SSP) www.sspnet.org SSP’s mission is to advance scholarly publishing and communication and the professional development of its members through education, collaboration, and networking among individuals in this field. Membership is open to any individual or organization from any of the scholarly communication sectors. Society for Technical Communication (STC) www.stc.org STC is an individual membership organization dedicated to advancing the arts and sciences of technical communication. Its 18,000 members include technical writers and editors, content developers, documentation specialists, technical illustrators, instructional designers, academics, information architects, usability and human factors professionals, visual designers, Web designers and developers, and translators— anyone whose work makes technical information available to those who need it. Membership is divided into eight regions each containing approximately 20 local chapters. In addition to the society leaders, each local chapter elects a set of chapter-level officers. 106 Becoming a Medical Writer The Organisation for Professionals in Regulatory Affairs (TOPRA) www.topra.org TOPRA is the global organization for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Membership is drawn from over 40 countries and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, the regulatory agencies and the consultancy community and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals. Appendix B Sample Job Postings from AMWA’s Job Market Regulatory writing Medical Writer It is an exciting time at Premier Research Group, a leading Contract Organization (CRO) headquartered just outside of London and with offices and staff across the United States, throughout Europe and Israel. Due to our continued growth, we are actively interviewing candidates for our Medical Writer positions, preferably based in one of our following offices: Austin, TX; Chicago, IL; Atlanta, GA; or San Diego, CA. Our Medical Writers are responsible for writing Clinical Study Reports, Protocols, Investigator brochures (IBs), as well as a variety of regulatory documents including, but not limited to, Investigational New Drug Applications (INDs), and New Drug Applications (NDAs), as well as other documents including manuscripts. Qualified candidates will have a minimum of five years experience preparing scientific, clinical, and/or technical documents (must include direct 107 108 Becoming a Medical Writer research experience) and demonstrated understanding of experimental methods, research design and statistics Must have a minimum of a bachelor’s degree (M.S. or Ph.D. in biological sciences preferred). Medical and Regulatory Writer This position fulfils the writing and editing needs of IDRAC’s United States (US) regulatory affairs module for the pharmaceutical and biotechnology industry. The primary responsibility of this position includes writing and researching for reports and timely news about US regulatory meetings. Responsibilities include researching, reporting, writing articles, and attending FDA advisory committee meetings, workshops, and relevant US pharmaceutical/biotechnology regulatory meetings, in the Washington DC/Maryland/Virginia Metropolitan area. Reports are to be written, edited, published, and executed by the end of the meeting. The ability to write quickly and succinctly under tight deadlines is a must. Additional responsibilities include writing about FDA product approvals, guidances, and other regulatory documents. Qualifications: Bachelor’s degree, preferably in journalism or English; experience in medical writing, regulatory affairs, or related experience will be considered. Qualified candidates must possess the ability to summarize FDA clinical reports and study protocols and the ability to research a variety of Becoming a Medical Writer 109 topics through various online resources (databases, internet), interviews, and observation. Proficiency in standard PC programs a must. Must be flexible with work environment; must be able to work independently from home and at meeting locations throughout the Washington DC/Maryland/ Virginia Metropolitan area; must be able to travel independently throughout the Washington DC/Maryland/Virginia Metropolitan area. Must be able to thrive under pressure; be highly efficient and independent; be able to complete tasks on a timely basis with minimal supervision and guidance; the ability to type and write quickly; excellent keyboard typing skills are required in order to type summaries of regulatory meetings under extremely tight deadlines; and good organizational and project management skills. Medical Education Senior Medical Editor QD Healthcare Group, a dynamic, unique, and growing medical education company based in Greenwich, CT, is searching for a senior medical editor with prior CME or promotional projects experience to develop content for medical education programs in various media and therapeutic areas, including cardiology, endocrinology, oncology, and rheumatology. Roles and Responsibilities: • Develop content, 110 Becoming a Medical Writer including hands-on creation of scientific outlines, drafts, and other material for advisory boards, educational symposia, teleconferences, articles, monographs, slide kits. • Edit manuscripts, slides, executive summaries for accuracy, clarity; • Incorporate author/reviewer revisions. • Ensure projects are prepared appropriately for client medico legal review. • Oversee accuracy and messaging of projects through all stages of content development. • Participate in planning of and attendance at advisory boards. • Provide strategic oversight and assure editorial quality of projects. • Develop and cultivate relationships with thought leaders. • Interface with faculty, account services, art, and meetings departments regarding content and design. • Manage and coordinate an external group of freelance writers and editors. • Travel to client and onsite programs as needed. Requirements: • 7+ years as an editor in medical education, pharmaceutical industry, or health care industry. • Ability to multitask • Experience in oncology, rheumatology, cardiology a plus. • Project management skills. Salary and Benefits: Salary is competitive and commensurate with experience. We offer a comprehensive benefits package including medical, dental, vision, flexible spending account, 401k, and profit sharing. Becoming a Medical Writer 111 Medical Communications Medical Writer, Medical Communications Under minimal supervision, critically evaluates, analyzes, and interprets the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias. Utilizes professional judgment and creative expertise to integrate the pertinent clinical data into an original summary document that is clear, accurate, concise, comprehensive, and devoid of promotional overtone. Provides evaluation of medical communication instruments and makes recommendation for corrective action. Assumes responsibility for ensuring that the finished document is complete, accurate and complies with approved format. This position will support the Professional Contact Center by developing standard response documents, FAQs, formulary materials, etc. Drug information and/or Drug Information Residency experience a plus. Education and Experience: • Requires a minimum BS degree in pharmacy or Doctoral level degree in a biomedical field. • 2 years experience in searching the biomedical literature. • 2 years experience in interpreting and using medical communication documents. • A successful candidate will have Regulatory Writing Experience. Knowledge, Skills and Abilities: • Knowledge of biomedical and pharmaceutical databases 112 Becoming a Medical Writer (e.g. MEDLINE, CANCERLIT, EMBASE, BIOSIS, IPA) and vendors for accessing them (e.g. DIALOG, OVID, SILVERPLATTER). • Knowledge of Boolean logic/operators. • Knowledge of medical terminology and basic statistical/clinical concepts. • Problem-solving capabilities and excellent organizational skills. • Excellent grammatical and communication skills. • Writer skills, i.e. command of outlining, drafting, revising, and reviewing. • Basic editorial and proofreading skills. • Detail-oriented. Methodical. Goal-driven. Good judgment. Able to work with minimal supervision. • Ability to prioritize. • Adaptable and flexible in nature. • Computer skills [word processing, spreadsheet, bibliographic management]. • Good interpersonal skills. Ability to work within a team. Manuscript editing at a journal Managing Editor Mayo Clinic in Rochester, MN, currently has a full-time opportunity for an editing-savvy candidate to perform substantive weekly online editing/revisions of all types of scientific manuscripts of up to 50 pages long written by physician-authors for publication in our monthly issue of Mayo Clinic Proceedings. We’ll rely on you to ensure the accuracy of all data in the abstract, all technical content (including tables, Becoming a Medical Writer 113 clinical photographs, and line art), all outcome measures as reflected in the results, and all conclusions, which must not go beyond the study’s actual findings. Your duties will also include directing all layouts and data presentations, proofreading all authors´ revisions and corrections, and following through on all editorial changes until each inconsistency is resolved. Qualifications: Bachelor’s degree in English, Journalism, or Communications, plus 5 years´ medical copyediting experience, preferably with a peer-reviewed medical journal. Strong multi-tasking, decision-making, problemsolving, and judgment capabilities are also essential, as is expert knowledge of the peer-review process and editorial reference material (e.g., AMA style). Certification by the Board of Editors in the Life Sciences a big plus. Mayo Clinic offers an excellent salary and benefits package. Public Health Writing Senior Health Writer Perot Systems Government Services is seeking Senior Health Writer Candidates in the Fairfax, VA area for our National Women’s Health Information Center contract. The Senior Health Writer is responsible for the writing, editing, quality control, and/or revision of contract materials that include: Frequently Asked Questions publications, posted on wom- 114 Becoming a Medical Writer enshealth.gov; Web site modules (special content sections) on both womenshealth.gov and girlshealth.gov; various print publications for women and teens, including booklets on breast-feeding and prevention tips; articles for the Healthy Women Today newsletter; advertisements; monthly “Did You Know” messages for the contract call center; and press releases. This person also will work closely with the client to maintain production schedules and receive edits and approval on the content of all materials. He or she will also work closely with the graphics department to ensure that the images used on products are appropriate for the health message. Additionally, the Health Writers are responsible for supervising the NWHIC Editorial Advisory Board which provides expert feed-back on materials. Education: Requires a Bachelor’s of Arts Degree or equivalent. Experience: Minimum 5 years of related experience. Specific Skills Required: Writing/editing experience for both consumer and health professional audiences on health information for women and adolescents. Experience developing low literacy and/or plain language health materials for consumer audiences. Knowledge of research methods required to produce comprehensive publications for consumer audiences (experience with Medline, CHID, other databases). Educational background in a health-related field and/or communications/journalism. Background in science/health. Desired Skills/Experience: Becoming a Medical Writer 115 Master’s Degree in public health or other health related field preferred. Knowledge of government health programs and initiatives. Knowledge of non-profit/professional organization health programs/initiatives. Any knowledge/experience breast-feeding. Freelance Opportunities Freelance medical/business writers Freelance writers wanted – International consulting company needs freelance writers with a solid understanding of both health care and business. Ideal candidates should be as familiar with NPV, EBITDA, and ROIC as they are with MI, COPD, and ADMET. They should also be able to explain complex medical and business concepts in clear, succinct prose. If you are interested in this opportunity, please let us know if you have a specific area of expertise, such as the drug discovery and development process, pharmaceutical sales and distribution, or how health care services are delivered and paid for around the globe. Medical Writer Immediate openings for contract Medical Writers in the pharmaceutical and CRO industries. Experience writing regulatory submissions, CSRs, investigator brochures and 116 Becoming a Medical Writer integrated summaries is strongly preferred. Competitive pay rates, professional and reputable representation. Appendix C Recommended Resources Books Bonk, Robert J. Medical Writing in Drug Development: A Practical Guide for Pharmaceutical Research. Haworth Press, 1998. Cohn, Victor, Lewis Cope. News & Numbers: A guide to reporting statistical claims and controversies in health and other fields (2nd edition). Iowa State University Press, 2001. Day, Robert A., and Barbara Gastel. How to Write and Publish a Scientific Paper (6th Edition). Greenwood Press, 2006. Gastel, Barbara. Health Writer’s Handbook (2nd edition). Blackwell Publishers, 2004. Krug, Steve. Don’t Make Me Think: A Common Sense Approach to Web Usability (2nd Edition). New Riders Press, 2005. McGovern, Gerry, Rob Norton, Catherine O’Dowd. The Web Content Style Guide: An Essential Reference for Online Writers, Editors and Managers. FT Press 2001. 117 118 Becoming a Medical Writer Meanwell, Michael. The Wealthy Writer: How to Earn a Six-Figure Income as a Medical Writer. Writer’s Digest Books, 2004. Ruberg, Michelle (Editor). Writer’s Digest Handbook of Magazine Article Writing (2nd edition). Writers Digest Books, 2004. Schwager, Edith. Medical English Usage and Abusage. Oryx Press, 1991. Strunk, William Jr. and E.B. White. The Elements of Style (4th edition). Allyn and Bacon, 2000. Zeiger, Mimi. Essentials of Writing Biomedical Research Papers (2nd edition). McGraw-Hill Professional, 1999. Zinsser, William. On Writing Well (30 aniv edition). Harper Collins, 2006. Manuals of Style Chicago Manual of Style, 15th edition. University of Chicago Press, 2003. JAMA & Archives Journals. AMA Manual of Style: A Guide for Authors and Editors. Oxford University Press, 2007. Huth, Edward J. Scientific Style and Format: The CBE Manual for Authors, Editors, and Publishers, 6th edition. Cambridge University Press, 1994. Becoming a Medical Writer 119 Medical Dictionaries Dorland’s Illustrated Medical Dictionary, 28th edition. W.B. Saunders Company, 1994. Stedman’s Medical Dictionary, 27th edition. Lippincott Williams & Wilkins, 2000. Mosby’s Medical Dictionary, 5th edition. C.V. Mosby, 1997. Web Sites HealthWeb www.healthweb.org Free medical journals www.freemedicaljournals.com Grant writing Tip Sheets (NIH) grants.nih.gov/grants/ grant_tips.htm Grant writing tools for nonprofit organizations npguides. org Guide to grammar and writing grammar.ccc.commnet. edu/grammar Medline Plus medlineplus.gov National Library of Medicine Online Databases www.nlm. nih.gov/databases Online medical dictionary www.online-medical-dictionary.org 120 Becoming a Medical Writer E-books Write An Article-A-Day, The Easy Way! Get Paid to Write on the Internet How to Write a Business Plan How to Write a How-to Book How to Write Feature Articles Magazines Writer’s Digest AMWA Journal Workshops AMWA Workshops Writer’s Digest Online Workshops