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Class of 2019: Inaugural Year of IMPACT’s Medical Writing Fellowship Program

January 28, 2019 | Laurel Kartchner, PhD, Amritha Kidiyoor, PhD, and Brandi Schuster, PhD, Medical Writing Fellows │ Medical Writing Services

More and more recent graduates want to break away from bench science but don’t know how or lack the industry experience that many pharmaceutical companies are now looking for. To facilitate this transition, some CROs like IMPACT have begun to provide fellowship and internship programs that offer hands-on experience for those moving from academia into a career in regulatory medical writing.

As of Spring 2018, IMPACT offers a unique full-time Medical Writing Fellowship with a goal of enabling aspiring scientists to become regulatory medical writers. The program is designed to focus on 3 main areas: 1) training and professional development, 2) quality control (QC), and 3) regulatory medical writing. This post summarizes our experience as the first group of fellows at IMPACT.

Training and Professional Development

Image courtesy of Sira Anamwong at www.FreeDigitalPhotos.net

On each of our first days working at IMPACT, we were a blank slate. None of us had any prior experience working as medical writers and were completely blind to the medical writing process. However, everyone at IMPACT wanted us to succeed, and so training sessions and mentorship were set in place to help introduce us to the field.

With little background in industry, we needed an introduction to drug development. Through IMPACT‑created modules designed to teach the fundamentals of medical writing, we learned the specifics of:

  • Drug development
  • Regulatory medical writing
  • Protocols
  • Early phase documents
  • Clinical study reports (CSRs)
  • Submission processes

These training sessions helped to orient us to medical writing at IMPACT and ensured our development as medical writing professionals.

Additional practical training taught us hidden tricks to using Microsoft Word (and each of us realized that writing our dissertations would have been so much easier if only we had known these tricks a few years earlier!). We also learned how to use such tools as StartingPoint, Excel (like a pro), and OneNote. Each component of training introduced a different skill that helped integrate us into our new roles as medical writers.

Quality Control

Armed with the tools and knowledge necessary for success, we then learned to perform QC. Recently, Nancy wrote about the why, what, when, who, and how of QC of medical writing deliverables. Producing high‑quality documents is one of the core values of IMPACT and as such, QC training is an integral part of the Medical Writing Fellowship.

Our introduction to QC began with a formal classroom session. In addition to the general concepts that Nancy outlined in her blog post, we learned the specifics of how to QC regulatory documents, the roles of the QCer and the author in the QC process, and best practices for providing comments and edits to authors. We also received in-depth instruction on how to reference and interpret source tables, figures, and listings for CSRs.

Following classroom training, we performed a QC exercise – a targeted review of changes to an example CSR and discussion of our findings. This provided us the opportunity to learn firsthand the level of detail expected during the QC process.

Image courtesy of Stuart Miles at www.FreeDigitalPhotos.net

Next, we performed shadow QCs of example CSRs that had been previously QCed by a seasoned professional at IMPACT. Our QC comments were compared with the existing reviews to determine if we caught all of the marked QC findings. Our performances on the shadow QCs were evaluated before performing QC of regulatory documents at IMPACT.

Once approved, we began QCing a variety of documents including Investigator’s Brochures, briefing books, protocols, CSRs, patient narratives, and orphan drug designation requests. We quickly learned about the diversity that exists in regulatory medical writing, even among the same types of documents! At first, it was a challenge to switch between different style guides from task to task, but we eventually became familiar with each Sponsor’s preferences.

Additionally, we had the opportunity to QC in-house publications such as newsletters, blog posts, and press releases. This experience allowed us to learn the internal processes for sharing company communications and to contribute to the public image of IMPACT.

Regulatory Medical Writing

In a previous post, Kim outlined the skills necessary to be a good regulatory medical writer. Entry‑level writers such as Clinical Research Scientists usually begin with authoring CSRs once they have found their footing as medical writers. As fellows (read: newbies) with minimal writing experience, we were given smaller roles in the beginning that have ramped up gradually.

We were first assigned to help with the finalization of event narratives, which summarize each adverse event experienced by clinical study participants. These were previously written by senior medical writers and we assisted with adding unblinded data, which allowed us to get a feel for:

  • What event narratives are
  • How they are structured
  • How to work with a team of authors
  • How medical writers at a CRO interact with Sponsors

Once we had gained some experience editing event narratives, we had the opportunity to author patient narratives, which summarize all adverse events experienced by a clinical study participant. This allowed us to become familiar with reporting procedures used by different Sponsors and Investigators and to learn what relevant information should be included in such narratives.

This introduction to narrative writing also helped us learn to manage our time to meet deadlines for short-term deliverables. Narratives usually have quick turnarounds, and for recent grads who are used to managing long‑term projects with flexible timelines, this change in pace takes some getting used to!

Image courtesy of Sira Anamwong at www.FreeDigitalPhotos.net

We are currently writing a CSR with close mentorship from a senior medical writer. Authoring a CSR has given us the experience necessary to begin developing our voices as medical writers. Furthermore, it has given us the opportunity to sit in on meetings with Sponsors where matters relevant to submissions are discussed.

In addition to CSRs and narratives (event and patient), we have also had the opportunity to work on non-clinical summary reports. During the short span of our fellowship, our exposure to the medical writing process has increased with each new project.

In a Nutshell

The Medical Writing Fellowship Program at IMPACT is structured to groom the fellows into the best regulatory medical writers possible. While the type of projects that future fellows will work on may differ from ours based on company needs, the emphasis on training and development, QC training, and regulatory medical writing will remain.

The exposure to a variety of regulatory documents, medical writing styles, and Sponsor preferences has provided us with a well-rounded fellowship experience. From project kick-off meetings to follow-up feedback, we are continually learning how to refine our writing and QC reviewing, which, in turn, has improved our skills as novice medical writers.

The value of our training and mentorship was greatly enhanced by the connections we formed with our colleagues at IMPACT. The inviting and supportive company culture was a warm welcome and a crucial part of our integration within the company. We have enjoyed participating in company initiatives outside of medical writing and QC tasks and appreciate the friendships we’ve made in the process!

IMPACT is an exciting, small CRO whose team has expertise in medical writing, regulatory affairs/operations, early phase clinical trial management, and drug development consulting. If you’d like to learn more about IMPACT or apply to the Medical Writing Fellowship, don’t hesitate to contact us!

Category: Medical Writing Services
Keywords:  regulatory medical writing, quality control, fellowship, internship, training, mentorship

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