Medical Writing is one of the most un-noticed booming service in the clinical research industry.There is an increasing need in the pharmaceutical and biotech industry for medical writing professionals. Medical writing specialists develop documents in a standard and well written fashion, compliant to regulatory standards for approval of drugs, devices and biologics.
Medical writing profession dominates the pharmaceutical and biotech industry by preparing the most critical and crucial documents for regulatory approvals. A few of the documents prepared by medical writers in the pharmaceutical/clinical research industry are clinical study reports (CSR), periodic safety update reports (PSUR), investigator brochures (IB), summary of product characteristics (SmPC), patient information leaflets (PIL), etc. On this regulatory end of the medical writing spectrum, medical writers work on all the documents related to submission for approvals.
The other end of the medical writing profession is towards the marketing of pharmaceutical and biotech products and public awareness related to healthcare. Medical and scientific writing in here involves a number of activities as shown in the figure. In case of medico-marketing writing the audience ranges from highly qualified physicians to scientific writing material for the general public.
The confluence of the two ends of the spectrum is where scientific manuscripts are prepared, and where publications undergo a systematic review to produce the best of evidence related to health care and scientific discovery.
Regulatory medical writers with a complete understanding of the clinical research processes expedite the traverse of a drug candidate over the path to physicians desk. Medical and scientific writing professionals working at the health care end of the spectrum form an important element in the communication channel sending information back to the laboratory for efficient translational research to take foundation.
In the wider clinical research industry, a large number of clinical research management organizations have recently developed which includes a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management and drug safety, clinical research consultancies, KPOs, etc. This has created a demand for skilled workforce in the clinical research industry as stressed in many business reports.
Xertz is committed to developing emerging professionals for the clinical research industry who are equipped with the most relevant and latest knowledge and expertise. Our trainers will provide you with a methodical understanding of the core areas of medical writing thus enhancing your skills and knowledge to the level expected of a Medical and Scientific Writer. It imparts rigorous medical writing training to develop professional expertise of high caliber. Our course curriculum is fully endorsed by the Clinical Research Industry and the academia thus imparting students the edge that they require to make an entrance in the industry. The main aim of the course is to empower professionals working in the clinical research industry with the advanced skills training and knowledge required to move to higher cadres of the management hierarchy.
Skills Required: First and foremost, medical writers should have solid writing and editorial skills, as well as familiarity with medical terminology. Scientific medical writers should be especially knowledgeable about the medical field and its terms and processes, and regulatory medical writers must thoroughly understand regulation requirements and approval processes. Successful medical writers are persistent and detail-oriented professionals who know how to research and can successfully translate a large quantity of technical information into succinct, engaging writing.
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