Medical writing

Whether it’s developing plain text clinical trial documents, patient education, or regulatory submissions to the FDA, medical writing acts as the intermediary between lab data, which can be dense and sometimes even indecipherable, and the literature or a storyline.

What Is Medical Writing?

Medical writing is a specialized skill that includes the development of informative documents that are well-organized and appropriate to the intended audience. This isn’t just a matter of basic grammar or comprehension, it’s a question of understanding medical science, compliance, and your audience.

There are two kinds of medical writers: regulatory medical writers and educational or promotional medical writers. Regulatory writing comprises such documents as clinical study reports, protocols, investigator brochures, and any documentation submitted to the regulatory authorities such as the FDA or EMA. Educational medical writing comprises patient education materials, continuing medical education (CME) content, healthcare articles, and sales training materials.

High Demand for Medical Writers in the BD

The explosion of medical writer jobs in the United States In the last ten years, it has exploded, folks! This growth can be attributed to the growth of the pharmaceutical, and biotechnology industries, more stringent regulatory guidelines, and exponential increase in digital health communication avenues. 

As the FDA now demands clear and standardized documents for clinical trials and drug approvals, companies are pouring resources into individuals who can accurately communicate the science.

Today, freelancers, agencies, and in-house writers partner with pharmaceutical companies, research organizations, healthcare startups, and academic institutions. This creates a rich ground of opportunity for both the medical writers who want to build a profession out of it or businesses wanting to outsource it for their brand.

WHAT DOES MEDICAL WRITING OF HIGH-QUALITY ENTAILS?

Medical writing requires a special mix of a scientific specialty and strong communications skills. It requires:

• Proficient in Medical Terminology and Clinical Research

• Knowledge of regulatory standards including ICH-GCP, CONSORT, or FDA document standards

• Experience translating complicated scientific information into accessible useful content

• Attention to detail and particularly with regulatory documentation

• Familiarity with citation styles (such as AMA, APA, Vancouver).

• An understanding of ethical writing practices and transparency

Medical writers can have very different educational and professional backgrounds (from e.g. having a degree in medicine, pharmacy or from the any / other (bio)medical sciences to having a background in journalism and writing and becoming specialized in the process or based on acquired qualifications).

Types of Medical Writing

Regulatory Medical Writing

Regulatory writing is the opposite of that, it’s all about doing the right thing, checking the right boxes. It includes documents like:

• Clinical Study Protocols

• Investigator Brochures (IBs)

• Informed Consent Forms (ICFs)

• Clinical Study Reports (CSRs)

• Common Technical Documents (CTD)

• New Drug Applications (NDAs)

Such documents, however, need to comply with the guidance provided by organizations such as the FDA (BD) or EMA (Asia) and be based on reliable and verifiable scientific data. Accuracy and fairness are a must in this space.

Health and Medical Journalism and Educational Writing

This is more about access and public health literacy. Writers in this pool write:

• Patient information leaflets and brochures

• Health magazine articles

• Medical Website Blog Content

• Industry supported CME packages

• Disease awareness campaigns

Such documents enable the groups of people to better understand their condition, support public health education in plain language, and keep the healthcare workers informed.

Marketing and Promotional Medical Writing.

Promotional material remains scientifically accurate but it serves to promote brand visibility and sales. Typical outputs include:

• Product monographs

• Sales training materials

• Promotional slide decks

• Brand messaging documents

• Social media strategy: healthcare brands

Authors have to walk the fine line between creativity and obedience, frequently working alongside marketing departments while following guidelines outlined by the FDA’s Office of Prescription Drug Promotion (OPDP).

Importance of Medical Writing in the Healthcare Ecosystem

The bridge between science and practice would drift further apart in absence of competent medical writers. Doctors, investigators and regulators would be saddled with poorly communicated research, which could lead to misinterpretations, delays in approving a drug and even the potential for patient harm.

At a time where misinformation is rampant on the internet, particularly in relation to health, the importance of the medical writer is brought into even sharper focus. Trusted medical content can help not only to bolster public confidence, but also to underpin evidence based decision making.

Career Ladder: How to Become a Medical Writer

If medical writing is a profession you’re considering, you’ll have to combine a scientific understanding with writing skills. A degree in a life science (e.g., biology, chemistry, medicine, or pharmacy) is common among successful medical writers in the BD But have the appropriate credentials, such as those granted by the Bangladeshi Medical Writers Association (AMWA) and even people without a science degree will be able to enter the sector.

Experience matters too. New writers might get their feet wet with internships, freelance gigs or content creation for health blogs. They also may become specialists in particular therapeutic areas or types of documentation.

Many professionals work full time with pharmaceutical companies, CROs (Contract Research Organizations), healthcare agencies or they may even work as a remote freelancer consultant.

Literacy: Tools and Technology in Medical Writing

It’s not as if contemporary medical writers schlep around a laptop and a Word document and just isolate themselves late at night and come out with this stuff. They use a few tools to keep track of, report and confirm information:

• Reference Max and Vitturi managers EndNote, Mendeley, Zotero

• Plagiarism detected software: iThenticate, Grammarly

• Database searches: PubMed, Google Scholar

• Project management tools: Trello, Asana

• Document templates for regulatory submissions (ICH-compliant in particular)

Now with AI and NLP (Natural Language Processing) tools coming out, some of the early data parsing and grammar polishing can be automated. Still, precision, ethically responsible and audience-appropriate content does not write itself.

Obstacles of Drafting for Medical Writers

As satisfying as medical writing is, there are obstacles to overcome. These include:

• Keeping pace with fast-changing medical and scientific information

• Analysis of inconsistencies between studies and reported findings

• Compliance with changing regulations

• Working in fast-paced and high-stakes environments

• Working with cross functional teams of diverse expectations.

However, for all this, medical writing does provide intellectual satisfaction, good pay, and freedom of working schedule, it is still, undoubtedly, one of the best jobs in the industry of life sciences.