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Medical Writing industry is on an upward surge, mainly driven by an increasing demand in Emerging markets to have high-quality documents authored to support timely drug approvals. At the face of the demand, more than the perfection in the domain, organizations should focus on obtaining clarity on what exactly is medical writing than being confused with science writing. How both the aspects differ?
Difference between Medical Writing & Science Writing
While science writing deals with writing about basic sciences, drugs and technological innovation for common readers, medical writing is all about developing clinical and scientific documentation in a standard, comprehensive, reliable and convincing manner. Medical writing demands special skills to produce well-structured documents that present information clearly and concisely. Medical writers require knowledge of therapeutic areas, the drug development process, pharmacology, drug safety, statistics, and regulatory guidelines. Thus, all medical writers can become science writers but all science writers may/ may not become medical writers.
Regulatory Medical Writing and what it entails
Regulatory medical writing often overlooked in the world of Medical Communications, is a vital component of clinical research. In the ever-changing regulatory landscape, skilled regulatory medical writing can add a lot of value to the overall production of clinical study documentation.
Right from protocol development to the drug submission process, every step requires comprehensive understanding of clinical trial lifecycles. It involves interpreting and summarizing complex scientific and statistical data, in turn providing effective guidance to the clinical study.
Typically, a regulatory writer should be skilled at understanding and fulfilling the needs, preferences, and styles of the concerned sponsors or study teams and should also possess comprehensive knowledge of global regulatory requirements to draft compliant materials adhering to guidelines such as International Conference on Harmonisation (ICH) Good Clinical Practice (GCP). Few regulatory writers gain expertise in a therapeutic area or disease and provide invaluable insights to the sponsors and study teams. If requested, they assist in documentation required for the approval of drugs by the regulatory authorities, who in turn assess the efficacy and safety of drugs throughout the clinical trials process and ultimately approve their use in a specified patient population.
Being a Pharma Regulatory field, a medical writer should work on a whole range of documentation such as, not limited to:
- Package inserts and patient information reports (PIRs)
- Clinical trial study data reports
- Pharmacovigilance documents like annual safety reports
- Periodic adverse drug experience reports (PADER)
- Common Technical Document (CTD)
- Patient safety narratives
- Clinical trial protocols
Science Writing and what it entails
Science writing includes writing about science, medicine and technological advances related to science aimed at the public who happen to be science enthusiasts. It is often confused with “scientific writing” which is a highly specialized technical writing by a scientist or science specialist, with an audience of other scientists. So even though science writing deals with issues of prime importance, it is not what you’ll find in a lab journal article, or a how-to scientific manual or a comprehensive research article published in a renowned scientific journal.
Science writers may or may not hold academic credentials in science, but they are well proficient in lucidly interpreting and explaining science to the wider public. The main aim of science writing is to narrow the gap between the general public and those with scientific expertise.
Science writing involves working on a wide range of available information such as:
- Popular science books, magazines, and newspapers covering scientific information, innovation or technological advances
- Science programs on Television or Radio
- Internet (websites, blogs, e-pubs)
- Digital science communication (videos, podcasts, slideshows and whiteboard lectures)
All in all, pharmaceutical companies across the globe are investing money on research for novel drugs, advanced medical devices, and novel diagnostic techniques. An increasing number of innovative drugs means an intricate process of clinical trials that demands the submission of documents to regulatory authorities. That indicates the growing need for thorough documentation processes. In these crucial times, organizations look for regulatory industry experts for strategic medical writing services right from writing exhaustive and time-consuming regulatory submission documents to providing consulting, training services or document template solutions. Be compliant with the right writing procedures.
