MEDICAL WRITING AS A CAREER OPTION

INTRODUCTION:

Due to the increasing number of research studies, growing clinical experiences, and new ideas, a large amount of new knowledge and information is constantly being added to the medicine and healthcare sector. All the information generated including research findings, devices, services, and products, is required to be communicated effectively to the target audience. Therefore, medical writers are highly desirable to communicate new information to health care professionals as well as the general audience.

Medial writing involves the communication of clinical and scientific information in form of a written document. The profession makes use of knowledge of both science and writing, thus combining the creative talent of the writer with the details of medicine and healthcare research to develop a well-structured scientific document. As science is dependent on clear and accurate reporting, good and effective medical writing are important, and lack of it can lead to meticulous research appearing flawed.
The medical writer works with scientists, doctors, and subject matter experts for describing research results, products in use, and related medical information. The writers have a responsibility to ensure that the document is in reference to the organization’s regulatory publication or guidelines in terms of format, structure, and content.

Medical writers are also a major part of the development of certain applications for mobile devices that are multi-purpose like:

1. Practice management and monitoring
2. Continuing education and training
3. Disease management
4. Medical reference and information-gathering

Medical writers are a key player in the medical communication team and have to perform multiple tasks related to quality assurance which includes:

1. Ensuring correct and consistent data throughout texts and graphics
2. Correcting spellings, grammar, and punctuations errors
3. Ensuring that the content and the organization complies with the appropriate guidelines and standards

Copyediting for making the writing clear, accurate and smoothly flowing

Therefore medical writing is a diverse profession as the person can be a writer, health care journalist, project manager, editor, educator, supervisor, and media relation specialist. Medical editors are exceptional at the gathering, organizing, interpreting, evaluating, and presenting complex information to a wide range of audiences, from healthcare professionals to the general public, and from industry professionals such as hospital purchases, manufacturers, pharmaceutical sales representatives, and users of medical devices to members of the insurance industry and public policy officials.
Depending on the audience, the language, documents, and deliverables varies.

TYPES OF MEDICAL WRITING

1. Regulatory Medical Writing- This type of writing involves writing documents for regulatory companies seeking approval for devices, drugs, and biologics. These types of documents include clinical trial data, regulatory submission documents, and post-approval documents. The person working as a regulatory writer gets an overview of the entire clinical development process, thus it is an ideal initial point for careers in the pharmaceutical industry like clinical research, regulatory affairs, document management, and marketing.
2. Medical Communications- This type of writing involves generating written, audiovisual, oral or online materials dealing with medicine and healthcare. These types of documents are written for providing information for general studies. The people practicing medical communications can move into publishing companies for editorial roles.

STEPS INVOLVED FOR WRITING A SCIENTIFIC DOCUMENT

1. Understanding the brief of the project– Before starting the document, the medical writer should understand the purpose of the document, understanding what the sponsor wants to achieve through the document. The writer notices the timeline to be followed, the data required for the study, and the process of review followed.
2. Literature search and review of information– The medical writer needs to do adequate planning and spend time on literature searches that can yield valuable information to support the document being written. Classification of retrieved information into useful chunks and finding a correct search strategy are two important steps in medical writing.
3. Authorization and compilation of the Document– Drafting the first version of the document is the step that takes the most amount of time. Getting familiar with the type of document, the purpose, and the contents are important for building the draft. Other than knowing the scientific part of the content, using proper language skills and moving according to the client style or in-house guide help in subsequent reducing of review and revision time. Apart from the main content, the document may also contain a number of appendices. The appendices are generally supplied by the sponsor; however, it is the duty of the medical writer to make sure that current and correct appendices are being compiled in the document.
4. The review process– This step involves reviewing the document by a senior medical writer and a subject matter expert (can be a clinician or therapy area expert). In the process, the content and the format of the document are reviewed. Peer medical writer cross-checks all the verifiable information from the source data, performing the Quality check of the content. However, before sending the document for further review, the medical writer should undergo a ‘self-review’ of the first draft.
5. Editing and formatting of the document– Every writer need to learn the editing and formatting of the document in order to make their document more acceptable and presentable. Formatting of a document involves checking the consistency of text’s size and font, checking the page numbers, line and paragraph spacing, margins and headers, and footers. In the editing of the document, the language, punctuation mark, spellings, use of tense, and the reference style is checked. Documents for publication are required to be rigorously proofread, copy-edited, and thoroughly checked for formatting requirements.
6. Approval and sign-off– The designated in-house or external approver needs to approve and sign off all the scientific documents. The approver should be given adequate time to review and sign off the document.
7. Electronic publishing of the document– This is the step when the document is made available in digital format for online access using the software tools available. The medical writer needs to be familiar with the use of this software.

TYPES OF DOCUMENTS WRITTEN BY MEDICAL WRITERS:

1. Medical Journalism-

• These types of documents are written for the general public.
• These are written in simple and non-technical language.
• Examples- newspaper and magazine articles.

2. Medical Education-

• These are written either for physicians or for the patients.
• For physicians, the medical writer writes textbooks, slide decks, and e-learning modules.
• For patients, the patient education material is written.

3. Medical Marketing of Healthcare Products-

• Manuals for salesforce and e-learning modules.
• Internet content for physicians and patients.
• Promotional literature like product monographs, brochures, and handouts, targeted at healthcare professionals.

4. Presentations and Publications-

• Abstracts
• Posters and presentations for scientific meetings and conferences
• Manuscripts like research articles, review articles, and case reports

5. Research Documents-

• Research Proposals
• Informed Consent Documents
• Investigator’s Brochure
• Clinical Trials Protocols
• Study Reports

6. Regulatory Documents-

• Subject Narratives
• Clinical Study Reports and Web Synopses
• Patient Information Leaflets

Each above-listed document has a separate target audience, therefore the language used and the level of technical information has to be taken care of according to the level of understanding of the target audience. Additionally, the regulatory documents have a set of formats and structures to be fulfilled and the content of the documents is guided by regulatory guidance and rules.

WORKING AREAS FOR MEDICAL WRITERS

• Pharmaceutical/healthcare product companies including medical device companies
• Contract Research Organizations and Business Process Outsourcing companies
• Scientific content and healthcare communication companies
• Media and Publishing companies and Medical Journals Academic medical institutions, Medical/scientific societies
• Healthcare Websites

CONCLUSION

Medical writing can be considered both an art and science. The profession requires a great aptitude for writing and understanding medical science. The job also requires the writer to be thorough with the knowledge of specific requirements to write different types of medical documents and should be updated with the guidelines to be followed. The demand for medical writers is growing rapidly over years. A number of job opportunities are being offered by the healthcare and pharmaceuticals industries. Both graduates and post-graduates of life sciences with the right skills and aptitude can pursue medical writing as a full-time career.