The Role of Regulatory Medical Writer in Clinical Research

Clinical Research has made tremendous progress in the last decade but still many diseases do not have the cure today. Hence, more the scope of medical writing than ever. Also, the future is unknown and volatile, many diseases have not even been discovered yet and may arise in the future. Covid-19 was one such example that was unheard of before 2019 and shook the entire world. The Pharma Industry is under constant pressure to deliver a cure for today and conduct research that helps secure tomorrow.

Many pharmaceutical products are development to find a cure for diseases with unmet needs. However, research is only half the process of what it takes to launch a new treatment any disease. It takes time to get approval for medicinal products before it is launched in the market. Whenever we buy any medicinal product, before its launch in the market, it takes years of development. It also involves the efforts of a lot of people who have achieved expertise by being in the field and after completing their studies like clinical research course or medical writing course. Hence, medical writing is a promising career for life sciences and pharmacy students.

The entire process of finding new treatment is extremely regulated and documented. Important documents are developed by medical writers at all stages of drug development. Imagine if these documents are not developed correctly, the cost can be pretty high as regulatory agencies can reject the approval of drug. This is the key reason; companies prepare highly skilled and trained medical writers.

The companies involved in the development of medicinal products communicate with regulatory agencies like US FDA, EMA, MHRA, DCGI, TGA, PMDA, and others. They write down and present their plans, procedures, protocol, findings, and other specific details, etc. Pharmaceutical, biotechnology, medical devices, and digital therapeutics companies all need skilled and trained staff, who have also completed a medical writing course, to write documents that demonstrate scientific research activities and findings to regulatory agencies.

The stream of this type of medical writing is called regulatory writing. One can become a regulatory writer by undertaking a regulatory writing course. Sometimes regulatory writing is used interchangeably with clinical writing as it is used during the clinical development of medicinal products.

Many companies support pharmaceutical, biotechnology, medical devices, and digital therapeutics companies throughout the clinical development of medicinal products. These companies are called clinical research organizations or contract research organizations (CROs). Many IT companies and specialized or niche CROs also support clinical development.

All these companies including biopharma, medical devices, CROs, IT, and others need skilled and trained staff in regulatory writing. Many of these top companies have invested in India for developing captive units and infrastructure to support their medicinal product development globally. These companies are recruiting in India at a pace to meet their global development. There are many job opportunities in India in the area of regulatory writing and clinical research for students who have completed a medical writing course.

Our Institute GAADS provide in-depth and extensive medical writing course which covers scientific and regulatory writing. The course is designed by industry experts which covers all the important practical aspects of medical writer.

For more information, please visit https://gaads.in/

The core skill set needed for regulatory writing are; understanding the target audience, basic understanding of healthcare terminology; Good command over English grammar, interpreting key messages, study design, project management, and collaboration skills to work with reviewers, use of software, and having ethical standards. If you are having knowledge of healthcare and flair to writer, you can be a successful medical writer.

The importance of preparing high-quality regulatory documents is highly significant. A Clinical Search Report (CSR) is the final result of many months and sometimes years of hard work by study teams, and has to summarize the conduct and results of a clinical study in a clear and unbiased manner. A well-written CSR will aid the subsequent production of high-quality submission documents, and conversely, poorly written or presented regulatory documents may lead to delays in regulatory approval, costing Pharma company, both time and money.

In the ever-changing regulatory environment, trained and skilled regulatory writers can add a lot of value to development of new treatment.

They understand, interpret, and summarize often complex scientific and statistical data whilst providing effective guidance to clinical study teams, which usually include experts from other fields such as clinical/medical, statistics, regulatory affairs, pharmacovigilance, and pharmacology. Some regulatory writers become experts in a particular therapeutic area or disease and can provide invaluable insights to the sponsors and/or clinical study teams. Regulatory writers can also perform quality control (QC), peer review, and provide other editorial support on documents produced by sponsors and/or study teams if required.

About GAADS:
GAADS is an edtech platform providing students with an opportunity to excel as a medical writer or regulatory writer at Pharma Companies, CROs, and MNCs involved in the Pharm industry. The program at GAADS is extensive and designed by industry experts. The insightful and in-depth course material gives students a practical approach to Medical Writing. The job-oriented course also offers a Certificate that is valid in the industry and helps students with their search for job opportunities with MNCs and leading Pharma Companies.

To Know more about GAADS medical writing course Visit: https://gaads.in/course/medical-writing-course

GAADS Learning Private Limited
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Email ankur.gohri@gaads.in

The GAADS provides high-quality training for medical writers through online learning. All online workshops are taught by industry experts and leaders with hands-on expertise in the topic. We run online workshops on a definite frequency. For details of upcoming online workshops, please register with us and you will receive emails on the updates. The online workshop program covers subjects that span all areas of regulatory writing course.

This release was published on openPR.