By Naureen Hameed
As graduate students and postdoctoral researchers, we constantly interpret, present, and write about our experimental findings. While we analyze our data, we start to see the broader implications of our research. Perhaps you begin to wonder, ‘Could this work lay the foundation for a groundbreaking medical device or drug?’ If so, it’s unlikely that you are exposed to each critical step that translate your findings into real-world medical products, such as drugs prescribed to patients, during your graduate education or post-doctoral research position. So, how does this transformation happen? A key component is documentation. Not just documenting the results of a clinical trial but the why and how the clinical trial will be conducted. This part of the process is where medical writing (MW) begins.
At a recent iJOBS panel, Dr. Preshita Gadkari described MW for regulatory affairs as the “science law” of medical writing. There are fixed expectations about formatting and language and each stage of preclinical and clinical studies requires specific documentation. Regulatory writers often work collaboratively on these various regulatory documents before they are sent to clinical trial sites or regulatory bodies.
The image above was taken from the iJOBS presentation, highlighting each stage where documents from MWs are needed. Before starting the trial, an Investigational New Drug (IND) application is submitted to the regulatory body that details the reasoning for initiating a clinical trial along with the regulations that will be followed. An investigator’s brochure (IB) is created at the start of a clinical trial and provides an overview of the trial through each stage. Data is added to the brochure as the trial progresses and is distributed to the trial sites to keep investigators up to date. Additionally, a protocol and amendments document detailing investigators and patients involved in the trial, the inclusion and exclusion criteria, and site-specific instructions is produced at the beginning of the trial and updated or amended when changes are made to the protocol. Informed consent documentation for each phase of the trials are also required.
By phase 2 of a clinical trial, a diversity plan is filed to describe representation in the clinical study and how the sponsor plans to include any underrepresented populations if there are any. At the end of each clinical trial phase, a clinical study report (CSR) is made to mark the end of the trial and summarize the results, such as the efficacy of a drug or immunogenicity of a vaccine and safety. Patient Safety Narratives get filed with the CSR, which detail patient information, such as medical history and reactions to the trial. At each stage of clinical trials and even post-trial, regulatory correspondence is maintained with regulatory officials to keep them up to date on the trial.
At the end of a successful clinical trial a New Drug Application (NDA) or Biologics License Application (BLA) is filed summing up the clinical trial and demonstrating how the drug successfully met expected endpoints. Filing the NDA or BLA signals to regulatory bodies that these drugs are ready for market. They are filed together with a common technical document (CTD) detailing the safety, efficacy, and quality of the drug or biological reagent across the clinical trial space.
These regulatory documents play a crucial role in bringing drugs to market. MW in regulatory affairs offers a unique opportunity for aspiring scientists who are looking to step away from bench work but remain actively involved in the drug development process. During this iJOBS event, panelists also shared insight into their own career journeys and offered valuable advice for those interested in pursuing a career in regulatory affairs medical writing.
The career panel was composed of four regulatory MWs who discussed the diverse roles and unique career path they took before becoming medical writers in regulatory affairs. Dr. Preshita Gadkari opted for “non-traditional” summer internship experiences as a graduate student, gaining experience in MW as an unpaid intern before becoming a publication MW, writing scientific manuscripts, conference abstracts, posters, and review articles for peer-reviewed journals. Eventually, Dr. Gadkari decided to trade-in her creative, marketing position for a more regimented position involved in the final phases of a study or clinical trial. A year and a half after obtaining her Ph.D., she accepted a regulatory MW position focusing on phase 3 and the post approval space of clinical studies for Merck. Dr. Gadkari is currently still in this position.
More “traditional” research scientist roles can also provide a way into the MW field. Dr. Abla Tannous, a MW manager at Carsgen focusing on developing BLAs, discussed how you can maximize a position as a research scientist at smaller pharmaceutical companies to prepare for regulatory MW. Dr. Aamani Boyanapalli exemplified this approach by developing methods and protocols that served as valuable resources during her time as a senior scientist conducting research on antimicrobial products at Colgate and later at Ethicon, a unit of Johnson & Johnson's medical devices division. She focused on these experiences when applying and eventually receiving a position in preclinical MW. In Dr. Maryam Alapa’s case, she utilized her regulatory MW externship experience during her Ph.D. to transition from a bench position in translational medicine to regulatory MW. Dr. Alapa quickly realized she did not want to continue her research scientist position at a large pharma company. In hindsight, this negative experience was the push she needed to pursue a career in something she always wanted to do, regulatory MW.
So, you may be wondering, what is the ideal entry position a graduate student should look out for at the beginning of their career in regulatory MW? Dr. Boyanapalli strongly believes that a position as a medical writer at a larger pharmaceutical company provides the essential training required to become a highly competitive professional in the field. In her first regulatory MW position at Regeneron, Dr. Boyanapalli worked in a very large and highly collaborative MW team. The team interpreted raw data obtained from their respective contract research organizations, determined key messaging with subject matter experts, and requested leadership approval to write. It was an excellent position to learn the ropes of regulatory MW. After becoming a mother, Dr. Boyanapalli decided to transition to her current role where she leads the nonclinical writing team at Astellas, a smaller biotech pharma company.
A career in regulatory medical writing offers a structured yet impactful way to apply analytical and communication skills honed during graduate training. As highlighted by the panelists, there are multiple pathways into this field, whether through internships, research scientist roles, or direct entry into regulatory writing positions. While larger pharmaceutical companies provide extensive training and experience, they often come with demanding workloads and limited flexibility. Smaller biotech firms may offer a better work-life balance. Regardless of the path taken, regulatory medical writing plays a crucial role in bringing new therapies to market, making it a fulfilling career option for those who enjoy interpreting data and contributing to the advancement of medical science.
Edited by junior editor Janaina Cruz and senior editor Antonia Kaz.