PS has worked as a freelance writer since 2012. When she's not traveling and writing, she helps people with web design and development.
- The medical field has seen a huge rise in the demand for writers in recent years. Due to the rapidly changing market dynamics, expiring patents, and exhausting product pipelines, there is a huge pressure on pharmaceutical companies to ask for outside help and outsource some of its non-core activities.
- This step will the companies to control expenditure and improve drug-production cycle time. One of these non-core activities is medical writing.
- Medical writing, certainly, doesn’t play a huge role in the starting of the drug development procedure, though there’s some mandatory technical writing required to do.
- It is very important when it comes to reviewing the measures to comply with the regulatory agencies, where a huge amount of documentation is needed.
Medical writing is the process of crafting well-structured and researched scientific documents. It includes writing clinically researched documents as well as content for health-related magazines, websites, journals, and news.
Two Basic Types of Medical Writing
Medical Writing can be written in two different ways categorized on the basis of purpose:
1. Regulatory Medical Writing
- Regulatory Medical Writing is writing content for regulatory agencies to get approval for drugs, devices, and biologics.
- It includes regulatory documents, clinical trial data, and post-approval documents.
2. Educational Medical Writing
- Educational Medical Writing is writing content about medicine, devices, and biologics for the purpose of educating others.
- It includes textbooks, journals, news and so on.
Types of Medical Writing on the Basis of Specialization
Earlier, I discussed two basic types of medical writing on the basis of purpose. Here are some more categories that you must know if you want to specialize in a particular sub-field.
1. Medical Journalism
- Newspapers and Magazines
- Targeted audiences are the general public and laypeople
- Use non-technical and easy-to-understand language.
2. Medical Education
- Physicians and Patients
- Slide Decks
- Education Material for Patients
- E-learning modules
- CME (Continued Medical Education) programs
3. Medical Marketing
- Promotional Material for healthcare professionals
- Training manuals
- E-learning modules
- Web content for physicians and users
- Journal articles
- Research articles
- Case reports
- Review articles
- Presentations for scientific purposes
5. Research Documents
- Study reports
- Investigators’ brochure
- Clinical trial protocols
- Informed consent documents
- Research proposals
6. Regulatory Documents
- Package Inserts
- Patient Information Leaflets
- Subject narratives
- Web synopses
- Clinical study reports
- Regulatory submission documents
Most of the medical writers deal with technical documents that are required to get approval from regulatory agencies for medical drugs and devices. The regulatory document is a broad term that covers the following types of documents:
- Clinical and non-clinical Technical Document
- Overviews and summaries
- Safety reports
- Expert reports
- PSURs (Periodic Safety Update Reports)
- PADERs (Periodic Adverse Drug Experience Reports)
- ASRs(Annual Safety Reports)
- Policy papers
- A medical writer’s job is highly profitable as well as exhilarating. He needs to work closely with doctors, scientists, pharmacists, and other SMEs to build effective documentation that clearly shows research results and the correct method to use the product.
- Besides writing skills, medical writers need to have great expertise in science and research fields to effectively present the information and produce appropriate documents for the targeted audience.
Reasons for High Demand of Medical Writers
- Development of innumerable drugs and medical devices through the complex procedures of clinical trials to receive market approval.
- Increase in the number of research studies in the biomedical field
- Considerate regulations of more and more biomedical journals
- The demand for web content for medical professionals and the general public to better understand the products.
Thus, there’s an unending demand for writers who can write well-defined documents in compliance with the standards, regulations, and formats.
Responsibilities of Medical Writers
- Writing clinical trial documents with high precision
- Extracting useful information from analysis reports and transform it into an understandable and readable format
- Creating monographs
- Participating in the development of product case studies and reports for submission to a regulatory authority
- Crafting promotional materials for new products in the market
- Developing medical reports and articles
Possible Job Opportunities for Medical Writers
Most of the medical writers’ work is conducted with the pharmaceutical industry to write documents that comply with regulatory agencies. Besides that, there are many other options as well:
- Pharmaceutical and healthcare product-based companies
- CROs (Contract Research Organizations)
- BPOs/KPOs (Business/Knowledge Process Outsourcing)
- Scientific research and communication companies
- Publishing companies e.g. Newspapers and Magazines
- Medical Journals
- Medical Institutions
- Medical and Scientific societies
- Healthcare Websites
Medical writers’ have a tremendous scope with a chance to earn a huge payout. You can either work as an employee for an organization or as a freelancer. You can consider it as a long-life profession.
Medical Writing is a highly competitive and challenging field, you need to have certain extremely mandatory skills to make a mark in this field:
- Great understanding of drug production methods
- Sound knowledge of ICH-GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice)
- Excellent writing and communication skills
- Good hold on the English language
- Ready to multi-task
- Knowledge of MS Word and Excel
- Aware of medical terminologies
1. Medical and Therapeutic area knowledge
- Proficiency in technical writing and communication.
- Basic knowledge of different medical specialties
2. Drug Development Process and Safety Measures
- Basic knowledge of pharmacology and pharmacokinetic concepts
- Understanding of safety measures prescribed by regulatory agencies
- Know-how of clinical and regulatory documents such as clinical study reports, investigator brochures, and trial protocols
- Knowledge of statistics to write about clinical trials and research studies
- Understanding of regression analyses, confidence intervals, P values, randomization schemes, and t-tests
- Attend medical workshops to about medical statistics though professional statisticians.
4. ICH Guidelines
- Along with international guidelines stated in ICH(International Conference on Harmonisation), also read national regulatory agencies’ guidelines.
- Various guidelines are available on how to write investigator’s brochures, clinical overviews, clinical study reports, and periodic safety reports.
General Knowledge and Skills
1. Language and Grammar
- Use active voice
- Use short and simple sentences
- Avoid technical jargons
- Write according to the targeted audience
- Learn AMA Style
2. Literature and Reference searching
- Be aware of authentic sources like PubMed and EMBASE.
- Craft a search strategy and use relevant keywords
3. Presentation of research data
- Review and interpret researched data
- Present them using tables and graphs
- Develop conclusion and logical discussion
4. Ethical and Legal issues
- Give the complete and right information
- Include negative findings
- Follow copyright laws
PubMed is your Best Friend
- Most of the medical writers visit PubMed on a daily basis.
- The sites include more than 21 million citations just for medical literature.
- It also has a database of life science journals and useful books.
- It is a must-have tool for medical writers.
Steps to write Scientific Documents
1. Understand Project Brief
- Define the purpose
- Understand clients’ requirements
- Mind the timelines
- Understand the review and approval process
2. Search and Review of Information
- Implement the search strategy
- Figure out the classification process for retrieved information
3. Compilation of Documents
- Build the first draft keeping in mind the purpose
- Use the pre-defined template
- Follow client style-guide
- Use correct and current appendices
4. Review Process
- Develop a review process for scientific documents
- Do a self-review of the content
- Have and editorial and formatting review
- Get it reviewed by SMEs
- Cross-check of information with the source data, must be done by peer medical writer
5. Format and Edit
- Check the consistency of text font style and font size
- Check paragraph and word space
- Check margins and page numbers
- Edit language (US or British)
- Check spelling and punctuation
- Check tense and reference style
- Proofread and copyedit before finalizing the document
6. Approval and Finalize
- Get approved by expert
- Sign-off the document
- Use pre-decided software tools for e-publishing
- Make sure the digital format is of good quality for online access
- Bachelors/Masters degree in life science-related field (not mandatory)
- Bachelors/Masters degree in the English language (not mandatory)
- Basic knowledge of human anatomy, medical terminology and disease pathology(extremely mandatory)
Types of Training
Besides having sound knowledge of the medical field, a medical writer needs to go through some training as well to know the practical aspects of the system.
1. In-house Training
- Organizations that recruit medical writers provide the required training so that they are familiar with the project-specifics.
- Training may include drug development process, drug safety measures, medical statistics and workflow, and style guides.
2. Short Courses and Workshops
- Professional bodies conduct few days courses and workshops to highlight major aspects of the medical field
- Some important topics are CSR, statistics and protocol writing
3. On-the-job training
- The senior medical writer conducts this training
- Training includes information about different types of documents
A medical writer must be self-motivated to train himself on different types of medical writing
The Internet has lots of medical writing courses available for beginners. The most renowned ones are:
- Freelance Medical Writing Course on Udemy
- Scientific Writing course from Stanford
- Various courses available at coursers
- Certification course by AMWA
Certifications and Organizations
1. American Medical Writers Association (AMWA)
AMWA is the leading organization in providing certification to the medical writers.
- You must have two years of experience in medical communications to get the certificate
- You will need to go through an exam.
- The website has various resources and essential skills certification to give you an edge in the competitive market.
- Join the membership of AMWA.
- The website offers lots of career opportunities along with job postings
- Attend AMWA’s annual gatherings and conferences to network with other medical writers
2. Board of Editors in the Life Sciences (BELS)
BELS is dedicated to the medical editors.
- It has great networking sources as well as very useful education resources.
- They also offer ELS credential.
3. Regulatory Affairs Professionals Society (RAPS)
A worth visiting website for aspiring medical writers to give yourself a kick start in your career
4. Editorial Freelancers Association (EFA)
The organization is exclusively for freelancers
- Medical writers can find a subtle amount of resources to earn better
- It has much more useful content, which can be availed by any type of freelance writer.
5. The University of Chicago Graham School
The university has a wide range of online courses available.
- You can study medical writing at reasonable cost from this website.
- You’ll also receive the certificate for the completion of the program.
6. National Association of Science Writers (NASW)
NASW is a leading organization for journalists and science writers.
- You can work as a biomedical journalist after studying from this website.
- It has excellent resources for journalism that can help you earn a substantial amount of income.
7. European Medical Writers Association (EMWA)
European Medical Writers Association is a non-profit organization based in Europe
- It has several resources and conferences exclusively build-up for medical writers.
- It is a home for freelance and in-house medical writers who work at pharmaceutical and medical communications companies
8. MedComms Networking
MedComms Networking is a global community of medical communications specialists including medical writers.
- You can network with other medical writers.
- You can find several job opportunities.
- There are various educational resources available as well.
9. Council of Science Editors (CSE)
Council of Science Editors is a non-profit organization that works in the favor of scientific writers.
- You can join its membership.
- You can also publish your articles.
- They also have room for annual meetings and committees to give you a head start in the field of medical writing.
For medical editors, the earning may vary from $27k to $80k on an annual basis.
For medical writers, the earning may vary from $50k to $100k or more on an annual basis.
Note: The earning amount also depends on the educational qualifications and experiences.