February 16, 2024 | Yash Patel, PharmD, Yamini Purohit, PhD, and Kelsey Gray, PhD – Medical Writing Fellows | Medical Writing Services
Regulatory medical writers play a key role in facilitating the development and compilation of documents that are submitted to regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with the aim of ensuring the safety, efficacy, and quality of medications and medical devices. The scientific nature of regulatory documents draws professionals with advanced, science-based degrees to this essential role. However, the career path to becoming a regulatory medical writer is far from well-established!
Syner-G BioPharma Group’s Medical Writing Fellowship Program addresses this gap by providing qualified individuals with practical, on-the-job training to gain the necessary experience to initiate a career in regulatory medical writing. The fellowship program was first launched in 2018 by Impact Pharmaceutical Services – a legacy company of Syner-G. Every year since then, the program has continued to prepare a small cohort of Medical Writing Fellows for a career in regulatory medical writing.
As members of the 2023 cohort, 3 of us joined the program bringing with us a diverse set of proficiencies: one of us was a graduate from an accelerated Doctor of Pharmacy program, one had prior experience with international science education research and program leadership as university faculty, and one of us had prior experience in research and medical communications. Given the diversity of our previous experiences, the overall design of the fellowship program supported us in our development as medical writers over the 9 months that followed.
Syner-G’s Medical Writing Fellowship Program focuses on 3 main areas: 1) training and professional development, 2) quality control (QC), and 3) authoring regulatory documents. Below, we share our experiences and learnings from our 9-month fellowship experience.
Training and Professional Development
Training and mentorship are integral to the Medical Writing Fellowship Program at Syner-G, and these were imparted in various ways: through structured training sessions, in the form of informal opportunities to participate in company-wide events (eg, lunch-and-learn-presentations), and in “real time” when working alongside a Mentor on assigned projects.
Structured training sessions were scheduled throughout the fellowship; these sessions spanned a wide range of topics related to regulatory writing and introduced us to Syner-G’s processes and best practices. Topics that we learned about included the following:
- An overview of the drug development process
- An overview of clinical study reports (CSRs)
- An introduction to the sources of data from clinical research studies (eg, tables, figures, and listings)
- A primer to interpreting specific types of data (eg, pharmacokinetics) from clinical studies
- Using client-specific templates and style guides
- Performing QC checks of regulatory documents
- Training modules related to Syner-G’s standard operating procedures
We also received orientation to helpful in-house resources and guidance for authoring CSRs and running effective meetings.
Additionally, during group events and lunch-and-learn sessions, we were introduced to practical tips and “hidden” tricks to using Microsoft Word, including authoring tools and templates. Participating in departmental and company-wide meetings helped us learn about evolving trends in regulatory medical writing and gain insight into the functions of other departments within Syner-G. Each component of training introduced us to a different skill that was essential to our roles as regulatory medical writers.
Quality Control
Armed with the tools and knowledge necessary for success, we then learned how to perform QC of regulatory scientific documents. Producing high-quality documents is one of the core values of Syner-G and, as such, QC training is an integral part of the fellowship program. A QC check confirms the accuracy of data and adherence to style guides, ensures that documents hold up to a high standard for our pharmaceutical clients, and is required per the regulatory guidelines!
Our introduction to QC began with a presentation during which we learned about the specifics of performing a QC check of regulatory documents, the roles of the QCer and the author, and best practices for providing comments and edits to authors. We also received in-depth instruction on how to reference and interpret programmed data tables, figures, and listings for CSRs.
After the training session, we worked on several “shadow QC assignments,” in which we performed QC of CSRs that had been previously QCed by a seasoned professional at Syner-G. Our findings from each shadow QC assignment were compared with those from existing reviews to determine if we caught all the marked QC findings. Reviewing feedback that we received on the shadow QC exercises gave us firsthand experience in how the process varies depending on the stage of document preparation (eg, a full QC performed during the initial stages vs a targeted QC performed after our pharmaceutical clients have provided feedback on documents). Our performances on these assignments were evaluated, and once we reached the required level of proficiency, we received clearance for conducting QC of regulatory documents at Syner-G!
Once approved, we were authorized to QC a variety of documents including CSRs, protocols, and integrated summaries. Initially, it was a challenge to switch between different style guides from task to task, but we eventually became familiar with requirements specific to each pharmaceutical client.
Through this training, we learned about the time and attention to detail that goes into providing the most accurate, consistent, and complete documents to clients.
Regulatory Medical Writing
Acquiring the ability to author regulatory documents is one of the main objectives of the Medical Writing Fellowship Program. Towards this end, we were assigned projects to gain hands-on experience with authoring CSRs.
Excelling as a regulatory medical writer requires a combination of knowledge-based skills, technical skills, and interpersonal skills. Entry-level regulatory writers usually begin with authoring CSRs.
Each fellow was assigned to co-author a CSR with a Mentor, who served as the “go-to person” for any questions or guidance. Under advisement from Mentors, we began authoring with simple tasks and gradually advanced towards tasks of increasing complexity. By the end of the fellowship, each of us had participated in the process of authoring at least 2 CSRs – end to end. Throughout the authoring process, Mentors reviewed our work and provided valuable feedback. Along the way, we also learned to manage our time to meet intermediate project milestones.
Additionally, we prepared for and participated in kickoff meetings, results interpretation meetings, and round tables to discuss feedback from clients. We also had opportunities to shadow other authors during meetings with clients, where matters relevant to submissions were discussed.
During the short span of our fellowship, each new project brought us unique opportunities to learn about the processes in regulatory medical writing. Because of the thoughtful approach to assigning projects, our projects were challenging enough to encourage us to go beyond our comfort zones, while also allowing us to experience success along the way!
Closing thoughts
While the types of projects that future Fellows will work on may differ based on company needs, the emphasis on training and development, QC training, and regulatory medical writing will remain. Exposure to a variety of regulatory documents, medical writing styles, and client-specific project requirements provided us with a well-rounded fellowship experience. From project kickoff meetings to delivering the final draft of a deliverable, we learned that refining our skills as authors and QC reviewers is an ongoing process! Each of us had a truly enriching experience as Medical Writing Fellows; the training met each of us where we were.
All of the above may sound like a LOT of work! However, work-life balance is not only encouraged but is integral to Syner-G BioPharma’s company culture. As Medical Writing Fellows, the project timelines on our calendars were punctuated by pauses to connect over weekly group meetings, celebrations of project milestones and holidays, and opportunities to socialize during virtual and in-person events.
Despite being a fully remote work environment, the strong camaraderie within the medical writing team helped us foster genuine connections. The value of our training and mentorship was greatly enhanced by the connections we formed with our colleagues. Syner-G’s supportive culture was crucial to us feeling integrated within the company.
Syner-G is a trusted partner in the drug development process with expertise in providing pre-approval through post-approval guidance. Integrated services offered through the Syner-G BioPharma Group include CMC support, medical writing, regulatory strategy, and regulatory operations. If you’d like to learn more about Syner-G or apply for the Medical Writing Fellowship, don’t hesitate to contact us!
