What is medical writing Medical writing is the

What is medical writing • • “Medical writing is the activity of writing scientific documentation by someone who is a specialized writer (a medical writer) and is generally not one of the scientists or doctors whose research it was. ” Medical writing involves writing scientific documents of different types which includes: Regulatory and research related documents Disease or drug related educational and promotional literature Publication articles like journal manuscripts and abstracts Content for health care websites, health related magazine or news articles.

Examples of Medical Writing • Journal articles – Original research – Review articles – Editorials, case reports, etc. • Abstracts – Publication in journals – Submission to medical meetings • Posters – Presentation at medical meetings • Slide presentations – Original research – Symposia – Roundtables – Advisory boards

• Medical education materials – Monographs – Training materials – Prescribing information • Regulatory documents – Clinical Trial Reports (CTR) – New Drug Applications (NDA) – Investigational New Drug Application (IND) • Marketing materials – – Advertisements Public relations materials Internet documents Patient education

DEVELOPMENT OF MEDICAL WRITING IN INDIA: PAST, PRESENT AND FUTURE • • • Medical writing is the fourth most commonly outsourced clinical development activity, and its global demand has steadily increased due to rising cost pressure on the pharmaceutical industry. India has the unique advantage of a large workforce of science graduates medical professionals trained in english and lower costs, which makes it a suitable destination for outsourcing medical writing services. The medical writing industry is on an upward growth path in india.

Types of medical writing Medical Journalism Eg: News paper and magazine articles Medical Education For Physician-Text book, continued medical education programme, slide desk and e-learning module For patients- Patients education materials Medical Marketing Promotional literature targeted at health care professionals, product monograph, brochure, handouts, sales force training manuals, elearning modules, internet content for physician and patients. Publication/Presentation Journal articles/manuscripts (Research article, case report and review article), abstracts, Posters and Presentation for scientific meeting and conferences Clinical trial protocols Investigators Brochures, Informed consent documents, study report and research proposal. Regulatory documents Package inserts (Prescribing informations) & Patients information leaflets, clinical study report, subjects narratives Regulatory submission documents-Common Technical document modules such as non clinical and clinical overviews& summaries, expert report, safety and efficacy summaries, Aggregate safety report such as Periodic safety update report, bridging report, Periodic adverse drug experience report, annual safety report, and policy paper etc.

Required Skills for Medical Writing • Attention to detail • Excellent writing skills • Interpersonal skills: communication at the time of interview • Organizational skills: creating and keeping deadlines, delegations, goal setting and meeting goal, Decision making, Managing appointments, Team management, Project management, Making schedule • Scientific skills: Observations, communicating, classifying, measuring, inferring and predicting.

SCOPE OF MEDICAL WRITING Pharmaceutical/Healthcare product companies including medical device companies CROs & Business/ Knowledge Process outsourcing companies (BPOs/ KPOs) Scientific content and healthcare communication companies (Functional Service Providers) Media & Publishing companies and Medical journals Academic medical institutions, Medical/ Scientific societies Healthcare websites

WHO CAN BECOME MEDICAL WRITER ? ? • • The basic Pre-requisite for becoming a medical writer is : Familiarity with medical concepts and terminology An academic qualification in one of the life sciences such as medicine or paramedical sciences such as pharmacy, microbiology, nutrition and dietetics, biochemistry and biotechnology Ability to write

MEDICAL WRITER SHOULD BE FAMILIAR WITH • • Medical and Therapeutic area knowledge- Medical writer communicates scientific information related to medical field Drug development process, pharmacology, drug safety- Medical writers involved in the preparation of clinical research and regulatory document such as trial protocol, investigator brochure, clinical study report of different phases of clinical trial, efficacy and safety summaries requires a thorough understanding of the drug development process, the clinical research and various guidelines. Statistics- Medical writers come across statistics when they write about clinical trial and when they write about research studies. Technical guidelines- EU, USA and JAPAN have evolved a set of common guidelines related to drug development and registration.

HOW TO BECOME A GOOD MEDICAL WRITER • • • Ability to understand the purpose and requirement of project Ability to write at a level appropriate to target audience Thorough research of the subjects Ability to think, logical organization of thoughts and ideas. Scientific accuracy Attention to details Ability to work across teams as well as independently good communication and cordination with various peoples involved in the process Good time management and meeting deadlines and commitments

STEPS IN WRITING SCIENTIFIC DOCUMENTS • • Understanding the project brief Literature search and review of information Authoring and compiling the documents The review process Formatting and editing Approval and sign off Electronic publishing

HOW TO BECOME A MEDICAL WRITER • • • There is no formal degree/ diploma or certification course in medical writing. Training in this discipline usually involves: In house training Short courses/ workshops by professional bodies On the job ‘mentor guided’ training Motivated ‘self-study’

Salary • Commensurate with experience and education • $38, 000 -100, 000+ • Mean income of full-time employees approximately $74, 000 • Pharmaceutical and communication companies pay best • “Interesting 6 -figure job” as seen on CNNMoney. com Gray and Hamilton. AMWAJ, 2004.

Tips for Writing Career • Build skills – Composition, grammar – Read medical literature • Training – Medical writing certification – Statistics • Networking – American Medical Writers Association (AMWA)

AT AN END • Medical writing is both a science and an art. It requires an understanding in medical sciences and an aptitude of writing.