What is Medical Writing and its Career Path?

Introduction

Medical writing is an art and science of writing scientific documents of different types and purposes for regulatory agency’s submission and approval, disease or drug-related educational and promotional brochure, leaflet and literature, published manuscripts and abstracts, health-related magazines or news articles. 

Medical writing for regulatory submission includes preparation of documents required by regulatory authorities for getting approval, marketing, manufacturing and authorization of pharmaceutical/nutritional/food products in respective markets.

The information in these documents should be supported scientifically either by in-house data (studies conducted by innovator) or may be references from published literature. The scientific information in these documents should be presented in a manner to suit the level of understanding of the different target audience, i.e., regulatory agency, physicians, medical professionals, patients or general public.

Medical writers should be aware of the medical concepts and terminology, relevant guidelines, the structure and contents of specific documents, and good writing skills. They should also have the skills of searching medical literature from different databases, research data analysis and interpretation skills.  

 

Scope of Medical Writing

Medial writers mostly work with the pharmaceutical industry. However, now a day there are many other establishments in which medical writers are required:

•          Pharmaceutical/healthcare and medical device companies

•          Contract Research Organizations (CROs)

•          Business/Knowledge Process Outsourcing companies (BPOs/ KPOs)

•          Healthcare Websites

The scope for medical writers is therefore incredible and rising. This is a profession which one can do either autonomously as a freelancer, or as an employee in any Pharma/ healthcare organization.

 

Types of Medical Writing

Medical writing usually involves writing diverse types of documents for different purposes, and target audiences. Following are the different kinds of medical writing:

Regulatory Documents

·    Package Inserts (Prescribing Information) & Patient Information Leaflets, Clinical Study Reports, Nonclinical Study Reports, Common Technical Document (CTD) Modules, Periodic Safety Update Reports ( PSURs)

 Research Documents

·      Clinical trial protocols, clinical study reports (CSR), Investigators′ Brochure (IB), Informed Consent Documents (ICD)

 Medical Education

·         For Physicians – Brochure, textbooks, educational materials, Continued Medical Education (CME) programs

·         For Patients – patient education material

 Publication/Presentation

·         Journal articles/manuscripts (original research articles, systematic review, case reports, review articles)

·         Abstracts

·         Scientific meetings/conferences posters & presentations

 Steps in writing scientific documents

 

•          Understanding the project

•          Literature search & review of information

•          Authoring & compiling the document

•          The review process

•          Formatting & editing

•          Approval and sign off

•          Submision/Electronic publishing

Requirements for becoming a Medical Writer

•          An academic qualification - medicine, pharmacy, microbiology, nutrition and dietetics, biochemistry, biotechnology

•          Medical & therapeutic area knowledge

•          Drug development process , pharmacology, drug safety knowledge

•          Statistics

•          Technical guidelines – EU, USA and Japan (International Conference on Harmonisation guidelines)

•          Language & grammar

•          Literature / reference searching

•          Interpretation and presentation of research data

•         Ethical & legal issues

Medical Writing Positions in Industry around the World at Varying Levels

•    Associate Medical Writer

•    Medical Writer I

•    Medical Writer II

•    Senior Medical Writer

•    Expert Medical Writer

•    Principal Medical Writer

Summary

Medical writing is both an art and science. The demand for medical writing is continuously growing over the years. Medical writing is the fourth most frequently outsourced service. Medical writers can work autonomously or full time employee in industry.

 

Reference:

 

1.      Sharma S. How to become a competent medical writer? Perspect Clin Res. 2010 Jan;1(1):33-7. PMID: 21829780; PMCID: PMC3149406.

2.      EMWA | A Career Guide to Medical Writing.