V39 N3 / 2024 ©2024 American Medical Writers Association. All rights reserved. ISSN 2163-5315 AMWAJournal.org 11 THEME ARTICLE ABSTRACT Ensuring that associate medical writers are set up for success requires a well-planned entry-level program that integrates training sessions with on-the-job experience. We describe how we have crafted our program for entry- level candidates—starting from our interview process and moving to our training program, how we embed them into teams and provide on-the-job training, how our support network is structured, and how we measure success. Feedback from recent participants in our training program offers valuable hands-on insights. A robust foundation of publication training is key to the development of our medical writers, providing skills and helping them develop many of the key attributes that underpin success, including attention to detail, effective storytelling, and industry compliance. Our profession is not static, and training programs need to be agile and pivot quickly to accommodate evolving industry standards, new technologies, and fluctuating client and audience needs and challenges. Staying up to date with future developments in medical writing is crucial, and we do our utmost to train and support our team and future- proof our training, so our junior writers are well equipped to excel and have fulfilling careers in the life sciences communication industry. INTRODUCTION Medical writers play a pivotal role in ensuring that clinical research findings reach their target audience in a timely manner. As the health care communication landscape evolves, nurturing the new generation of medical writers is paramount. Developing an engaging, informative, and relevant training program for aspiring medical writers will prepare them for the varied aspects of their working life and ensure they have the best start to their careers. Through comprehensive training, medical writers develop their skills to disseminate scientifically accurate, engaging, and industry-compliant information that will contribute to knowledge of health care advances and ultimately benefit patients. It is essential, therefore, to understand and nurture the multifaceted role of a medical writer. The ability to pivot between diverse types of projects—with strategic acumen, a sharp eye for accuracy, proficiency with digital tools, and a flair for scientific storytelling—is no mean feat, particularly in the rapidly evolving life sciences communication industry. Given that the use of generative artificial intelligence (GenAI) in medical communication is progressing at a rapid pace, the skills of the medical writer must evolve too. Expertise in the critical evaluation of GenAI content will be an essential skill as, in the not-so-distant future, this task becomes a part of a medical writer’s daily life. Leaders of entry-level training programs have a responsibility not to shy away from this new technology but to embrace it, train for it, understand how it impacts our clients and audiences, and incorporate it into training plans. A medical writing career can be an inspiring and exciting one. With opportunities for continued learning and knowledge expansion through training and experience, there is rarely a dull moment in this field! To ensure that medical writers are set up for success throughout their careers, training programs should be tailored to all levels of ability and experience. This demonstrates the company’s investment in staff and encourages an environment of shared responsibility for continuous learning and development. For example, in addition to our entry-level program (IGNITE), the authors’ company also offers an internship program and training tailored to mid-level staff and those moving into leadership positions. These training programs are designed to build confidence in projects of increasing complexity, provide more in-depth training on strategic oversight, and ensure the development of broad leadership skills. To enhance understanding of the purpose and connection with the training, across all levels, we tailor it around our four company values: be brave, be human, be passionate, and be exceptional (Box 1). Training the Medical Writers of the Future Using a Structured Entry- Level Program: A Life Sciences Communications Agency Perspective Michelle Utton-Mishra, PhD, CMPP1; Melissa K. Purves, PhD, CMPP2; Linda Mascarenhas, MS1; Valerie Moss, PhD, CMPP1 / 1Prime, London, United Kingdom; 2Prime, Knutsford, United Kingdom http://www.amwajournal.org AMWAJournal.org 12Training the Medical Writers of the Future Using a Structured Entry-Level Program Here, we describe our entry-level program for the benefit of potential future medical writers and those wishing to set up a similar training program, sharing what training works well, offering feedback from our recent trainees, and offering insight into how we are developing the medical writers of the future. OUR ENTRY-LEVEL PROGRAM At Prime, our entry- level program, which encompasses 12 months of training and on-the-job experience, has been running in its current format for over five years across the United Kingdom, Europe, and the United States. The program is designed to train junior medical, market access, and patient writers, account executives, and editors to become the life sciences communication stars of the future (Figure 1). Regardless of department, our trainees attend all sessions and gain broad awareness of the skills needed across the field of life sciences communication through incorporation of elements of writing, editing, and client service projects into the entry-level training sessions. In this way, we equip all junior staff with skills and understanding relevant to many areas of the life sciences communication world, providing a good introduction to collaboration and how to function within a high-performing team. Our journey begins with our rigorous recruitment process. For aspiring writers, this process involves writing a mini review per a detailed brief with source materials; a live, timed writing test; and real-life scenario interview discussions. When successful candidates come onboard, they enter our program from their first day. We assign each candidate to a home team with a line manager in that same home team. They integrate into the workings of that team, getting up to speed with the team’s ongoing work, shadowing colleagues, and taking on live tasks with supervision from their second week. We also assign each candidate a buddy (usually someone from a different team who has been through the entry-level program themselves) who can befriend, support, and answer any questions more casually than a line manager and be a friendly face around the office. We start our training by bringing the candidates together in a live classroom setting. They have the opportunity to spend time with each other, which builds camaraderie among peers, and are introduced to many of our team, both for training and informal catch-ups over coffee. We aim to create an environment in which everyone feels nurtured, comfortable to learn, and encouraged to contribute. Our training program for medical writers is crafted by our senior scientific team, including our chief scientific officer. The training is delivered by a variety of individuals who have recent hands-on experience, including senior medical writers, and scientific directors. We also organize many sessions given by the wider team, including members of the client services, editorial, finance, digital, evidence and access, and patient engagement teams. This ensures What are your top tips for someone starting a medical writing career? Firstly, to read published manu- scripts and any other available mat- erial; secondly, to ask for feedback and be open to feedback—talk to your colleagues to put things into perspective; and lastly, to be exposed to as many different types of medical writing as possible. Interviewer and Hope, an associate medical writer. Hear Hands-On Experience from an Associate Medical Writer Video 1. https://f.io/E6aeNhl9 Figure 1. Overview of our entry-level training program. F2F, face to face. http://www.amwajournal.org https://f.io/E6aeNhl9 AMWAJournal.org 13Training the Medical Writers of the Future Using a Structured Entry-Level Program our trainees have a fully rounded introduction to various aspects of life sciences communication. Our initial round of training sessions set the scene by introducing the job role and pharmaceutical development process, along with soft skills to build confidence. For example, introductory sessions include An Introduction to: Pharma and An Introduction to: Drug Development, also some role-specific sessions, such as Spotlight on: Client Services. After these initial settling-in sessions, the program expands to cover the many elements of life sciences communication in a blend of live, virtual, and self-led training sessions. Topics include: • core publications skills (how to data or fact check, how to approach writing an abstract), • digital production (marking up PDFs, working with the creative team, how to approach developing a poster), and • patient engagement (spotlight on patient engagement and centricity). In addition, we keep the program fresh and introduce contemporary subjects as they arise, such as the impact of GenAI on our industry and how to verify GenAI content, presented by in-house subject matter experts. We pair the topics with the most appropriate method of delivery, based on the length of the training and level of interactivity required. Straightforward topics are either delivered as virtual or self-led sessions, whereas more involved, interactive training is performed live. Having a range of delivery approaches means that, overall, sessions are well- attended, and trainees are engaged. We are conscious that everyone may have different preferences for learning styles, so our curriculum comprises bite-size training materials, slides, videos, task-based learning, and discussion-based sessions. We ask that cameras are turned on for virtual and hybrid sessions, and ensure the format is as interactive as possible, including polls, asking questions throughout, and allowing ample time at the end for discussion. All sessions are recorded and shared, so anyone can return to materials at a later date or catch up on any topics they may have missed. Line managers, buddies, and the program organizers work together to ensure everyone’s needs are met and views heard. During the 12-month program, we organize group training days in which we ensure everyone meets face-to- face for live training sessions and some fun downtime. The trainees also have the opportunity to hone their presentation skills within a safe space by presenting to each other. The program leads track progress, successes, and challenges through regular meetings with line managers and trainees. A sense of community is encouraged among the trainees throughout. We feel the balance of background training, on-the-job project work, and genuine care that is taken supports company loyalty and encourages staff retention, with many of our trainees progressing to mid- and then senior-level positions within the company. For an associate medical writer, the on-the-job training starts with a firm grounding in the need for accuracy and attention to detail. They will perform data checks in parallel with more senior colleagues until they feel confident and ready to go it alone. Publication writing training is built into the program early on as it gives a good foundation in the other skills needed for medical writing, including experience in interpreting data, ability to develop engaging long-form storytelling, and adhering to the compliance standards of the role. A medical writer supports the author to develop drafts of a publication, facilitating timely publication under author direction.1 Understanding publication process is an important part of initial training and allows our associate medical writers to become publication professionals with a strong understanding of our own and client procedures, and a commitment to publication standards of excellence. We also hone scientific storytelling skills throughout all our training, ensuring our writers feel empowered to undertake multiple project types. As our associate medical writers grow in confidence, they begin to engage in other publication projects, taking on client and author interaction responsibilities when they are ready and attending kick-off calls, implementation of good publication practice, and development of deliverables such as graphical abstracts, infographics, video abstracts, and plain language summaries. Understanding the strategic relevance behind a publication plan and ensuring an omnichannel approach to reach the right audience, with the right material, at the right time, via the right medium, is discussed early in the entry-level program. The health care landscape in How might the career of a medical writer change in the near future? Writers will need to embrace a lot of different needs going forward, especially in an environment where there is strong demand for an omnichannel approach. […] In addition, writers will need to continue to learn more about generative AI and how it can help them deliver more […] as well as identifying where we can innovate using technology platforms […], learning how to deliver not just science—but deliver science strategically. Interviewer and Moamen, associate scientific team leader and former member of our entry-level program. Hear a Former Trainee Discuss His Life Sciences Communication Journey Video 2. https://f.io/E6aeNhl9 http://www.amwajournal.org https://f.io/E6aeNhl9 AMWAJournal.org 14Training the Medical Writers of the Future Using a Structured Entry-Level Program which medical writers work thrives on interdisciplinary collaboration between a broad range of health care professionals, researchers, pharmaceutical colleagues, and patients. By collaborating with patients and professionals from various disciplines, our medical writers gain invaluable experience and learn to adapt their writing style to different audiences. How to Measure Success For our associate medical writers, we benchmark success against a set of objectives, some universal to the job role and others specifically tailored to each individual. These objectives cover research and writing ability, communication skills, team working, time management, industry compliance, and financial awareness (Figure 2). Progress toward objectives is reviewed regularly with line managers, and associate medical writers are encouraged to keep a record of their achievements in a centralized human resources system. Clearly defined promotion criteria that assess competency in the objectives outlined above are available to line managers and associate medical writers, ensuring that standards are transparent and there are no hidden hurdles. Similarly, associate medical writers have access to clear job descriptions for their current and next role, which helps them understand what they need to work toward as they progress through their career. This clear, information- first approach means that all associate medical writers have a good understanding of what is expected of them, which helps reduce the instances of performance concerns. Occasionally, our associate medical writers experience challenges as they navigate the complexities of life sciences communication, and we have tried-and-tested approaches in place to help them overcome any obstacles. These approaches include access to buddy mentors who have been through the program themselves and can provide guidance on how to navigate what is, for many, their first job after college. Secondly, our associate medical writers have access to a peer support network in the form of the other trainees (including other writers, editors, and account executives) who are part of their cohort. Learning to work as part of a team is a pivotal part of training. Our associate medical writers are encouraged to reach out to their buddies and peer group to discuss challenges and identify solutions; in most cases, challenges can be overcome through these informal discussions. We have observed first-hand how well this approach works, and how effective it is at developing problem-solving skills. Thirdly, all associate medical writers have a dedicated, experienced line manager with whom they have weekly touchpoints to discuss progress, as well as ad hoc catch-ups as needed. Line managers are trained to provide support and help their line reports to navigate potential challenges. Finally, all our trainees have regular meetings with the program heads who check in from an emotional and social support perspective. These catch-ups are usually informal and provide another opportunity to discuss concerns, explore challenges, and access support as needed. Our approach has shown success since our entry-level program began in 2017, with 154 candidates entering the program to date. The vast majority of these candidates have completed the entry-level program and are highly trained, resilient, and well rounded, with a passion for life sciences communication and the ability to thrive in a fast-paced and evolving industry. We are proud that they have gone on to fulfilling and rewarding careers, and many are now passing on their skills to develop the medical writers of the future. Ways of Working, Now and in the Future We have seen many changes in life sciences communication since the start of our entry-level program, and it is Figure 2. Setting colleagues up for success. http://www.amwajournal.org AMWAJournal.org 15Training the Medical Writers of the Future Using a Structured Entry-Level Program important that we continue to evolve to ensure we remain future-proof. For example, one of our cohorts was initiated in 2020, just before the COVID-19 pandemic. We had to quickly pivot to a virtual training program while ensuring that our new recruits had the same standard of formal training and on-the-job learning opportunities as those who started before the pandemic. Luckily, our team is very resilient; they adapted quickly and embraced these needs, taking every care to give our candidates the best experience possible. The challenges posed by the pandemic underscored the importance of community and added an element of joint accountability, with trainees expected to attend virtual meetings, specific training sessions, and all opportunities for online social events and informal get-togethers. Four years on, we (along with many other industries) are now very much in a hybrid world. Our trainees are encouraged to come into the office for two to three days per week. We feel this offers the best of both worlds, with trainees exposed to in-person conversations that support their learning in an informal way and help them forge close relationships more quickly than in the fully virtual setting. In the evolving medical writing landscape, embracing modular content creation is a crucial mindset shift for effective omnichannel communication. The omnichannel approach, delivering the right content to the right audience at the right time via the right channel, requires truly understanding the audience, their needs, and their preferred way to receive information. The ability to create content in modules that can be adapted across platforms is key with this approach and needs to be incorporated into processes and training programs to equip medical writers with the skills to maximize the reach and impact of data. In addition, there has been a lot of interest in the use of GenAI to develop medical content, with the aim of streamlining workflows and quickly tailoring content to different styles and audiences. It is important that our writers understand both the risks and the benefits of emerging technologies, so we provide clear guidance on disclosures, transparency, and the importance of ensuring human oversight and validation within our training program.2 GenAI may be used in a variety of ways in the future, but medical writers will remain the subject matter experts. Over time, they will gain skills in critical thinking, how to interpret data and provide context, and strategic content validation, skills that will be increasingly critical and require appropriate training as we move further into the GenAI era. CONCLUSION Supporting the next generation of highly skilled medical writers is a multifaceted endeavor that requires a comprehensive training approach encompassing strategic, scientific, and clinical knowledge; communication and storytelling skills; technological proficiency; and an understanding of industry compliance. A comprehensive training program will bring together all the necessary instructional elements and on-the-job experience to empower medical writers to shape the future of life sciences communication. We must continuously evolve our educational approach and our materials – from updating information to staying in line with industry standards to improving how we deliver our training sessions. We are always looking for new ways to enhance participants’ engagement, build in interactivity and discussion-based sessions, monitor training achievements, and awareness of how to stay ahead of the latest industry trends. Exposing medical writers to the plethora of project types and approaches we can take to support our clients and inform our audiences will encourage them to “Be Brave”—to challenge established ways of thinking and suggest an alternative solution. This will not only result in forward- reaching communication that meet target audience needs and ultimately result in patients receiving the best care possible but will also ensure we always put our best foot forward to support successful medical writing careers. Acknowledgments Many thanks to all our IGNITE cohorts and our colleagues who support in providing and organizing training, line management, and overall support. Special thanks to Tom Gegeny, ELS, MWC, CMPP, of Prime, New York City, NY, for critical review, Gaurav Kumar, MSc, of Prime, London, United Kingdom, for input, and Laura McArdle, BA, of Prime, New York City, NY, for editing. Author declaration and disclosures: All authors are employees of Prime, Knutsford, United Kingdom. Author contact: Valerie.Moss@primeglobalpeople.com and Michelle.Utton-Mishra@primeglobalpeople.com References 1. DeTora LM, Toroser D, Sykes A, et al. Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Ann Intern Med. 2022;175(9):1298-1304. 2. International Society for Medical Publication Professionals (ISMPP) position statement and call to action on artificial intelligence. Curr Med Res Opin. 2024;40(1):9-10. http://www.amwajournal.org