Published on April 9, 2018 | Last Updated on July 2, 2022 by Lookforzebras
- Job Responsibilities
- Work Environment and Schedule
- Required Skills and Training
- Is This a Career for You?
Medical writing jobs for physicians come in numerous flavors. Scientific and regulatory writers are a subset of medical writers who work in the pharmaceutical, biotechnology, or research industries, and are responsible for presenting research findings and data in a clear, concise manner. They are often logical, data-driven individuals, with a desire to deliver research findings, write protocols, or draft regulatory documents in an orderly fashion. They are responsible for communicating results from clinical trials to the FDA, drafting prescription leaflets for new drugs, or writing up manuscripts to submit to medical journals, among other roles.
As the pharmaceutical and biotechnology industries grow, there continues to be an increasing demand for scientific and regulatory writers. They collaborate with scientists and clinical researchers to accurately convey scientific findings and craft regulatory documents for submission to governmental and industry regulatory bodies. Although both terms – regulatory and scientific – may be used concurrently to describe a writing role, there are some differences in responsibilities. Regulatory writing is a field narrower in scope, usually drafting documents for approval of a drug or product by a regulatory body, such as the FDA, while scientific writing can be applied more broadly to individuals who write scientific, highly technical, or research documents for various purposes.
|Regulatory Writers||Scientific Writers|
|Types of Documents Written||▪ Drug package inserts ▪ Clinical study reports ▪ Protocols ▪ INDs or new drug applications ▪ Safety and efficacy summaries ▪ Adverse drug experience reports||▪ IRB proposals ▪ Informed consent documents ▪ Abstracts and journal manuscripts ▪ Other research documents or items for publication or presentation|
|Intended Audience||▪ Regulatory bodies ▪ Ethics committees||▪ Physicians ▪ Scientists ▪ General public|
|Employer Types||▪ Pharmaceutical company ▪ Medical device company||▪ Research company ▪ Medical communications agency|
Job responsibilities may vary slightly depending on the particular position, but overall are relatively similar between scientific and regulatory writers. The writing is technical in nature, often with very specific protocols delineating outline and content inclusion. Regulatory writers are those considered to draft clinical documentation for research and approval of new drugs by the FDA (in the US), and are therefore subject to strict guidelines for submission and approval. Scientific writing is a more inclusive term that can refer to those working on technical, research, or protocol type documentation in a variety of scientific or clinical areas, but generally not as tightly regulated as regulatory writing. Scientific or regulatory medical writers should be comfortable with data and analyzing research findings because often projects may include compiling reports from raw data. Various job responsibilities may include:
- Reading statistical reports and compiling data into succinct summaries and reports
- Preparing research proposals, informed consent documents, abstracts, or journal manuscripts
- Writing reports on adverse drug incidents or the safety and efficacy of a drug
- Writing summaries of different phases of clinical trials for submission to the FDA
- Drafting INDs or NDAs (for investigation or approval of new drugs) according to common technical document protocol for submission to the FDA
- Drafting prescription information to be included in drug package inserts
- Collaborating with other professionals including statisticians, clinical researchers, and editors to review protocols, clinical guidelines, manuscripts, or other documents
- Competently performing medical literature searches to supplement documents
- Writing or updating investigator brochures providing all known information about a drug being studied
- Reviewing statistical tables and figures for errors or formulation of appendices
Work Environment and Schedule
Scientific and regulatory writers can choose to work as freelancers, taking on writing assignments as they please. They can also work as a consultant to pharmaceutical companies at a medical communications agency, or work as an employee of a pharmaceutical, research, or biotech company. Generally, those working as freelancers have the most schedule flexibility, but also potentially less stable work flow and pay. Working in scientific or regulatory writing may be stressful at times due to large amounts of data to review, regulatory document guidelines to follow, and writing deadlines to meet for drug submissions. On occasion, long hours may be required to complete a writing assignment or project. As with many writers, hours are often flexible and at the control of the writer, which requires excellent time management skills. Writers need to be comfortable with criticism and revision of their work as necessary for proper submission. There is often a wide variability in the tasks and domain areas required of scientific and regulatory writers. Physicians hoping for more continuity may be able to specialize by working for a particular clinical research organization focused in a particular field, such as neurology or immunology. They may also find that working in the pharmaceutical industry writing regulatory documents allows them to perfect their craft. This is because the format of the documents is very standardized, although the subject matter for the drug submission may change.
Required Skills and Training
No specific degree is required to work as a scientific or regulatory writer, although most have at least a bachelor degree in a science- or writing-related field. A degree in an area of life sciences such as medicine, pharmacy, microbiology, nutrition, or biochemistry is generally preferred. Many writers have a professional or advanced degree such as RN, MD, or PhD. Scientific or regulatory writers must also be familiar with the protocols guiding the industry in which they work, such as the Common Technical Document (CTD) guiding the outline of documents submitted to the FDA in the pharmaceutical industry. Often employers provide all appropriate resources and updates regarding education of these protocols. Required skills include:
- Ability to express information clearly and succinctly
- Clear understanding of medical content and terminology
- Understanding of research design and protocol
- Ability to interpret data and results of statistical analysis
- Understanding of basic chemistry, pharmacokinetics, and pharmacodynamics
- Understanding of protocols or governing bodies overseeing industry (such as ICH, CTD, and FDA for pharmaceuticals)
- Comfortable performing medical literature searches and reviews
- Clearly communicate and collaborate with interdisciplinary teams including scientists, clinical researchers, and editors
Residency, Licensure, and Training Requirements
There is not typically a requirement for residency completion, board certification, or an active medical license.
Is This a Career for You?
Scientific and regulatory writing may appeal to physicians or healthcare providers with an interest in research and clearly conveying technical medical language. Regulatory writers may feel a sense of satisfaction in knowing the work they contribute assists in getting a drug or product to market, influencing the lives of the general public. Depending on the specific position, there is the potential to compose a wide variety of documents for different therapeutic areas, so the variety could provide a stimulating and educational work environment. This is not an area for creative writing, and instructions are very well delineated. Therefore, if you despise ambiguity and like having specific instructions and protocols to follow, this career may be well suited to you. Physicians who have worked in academic research, written clinical guidelines, or worked in quality improvement at their institutions may enjoy working in scientific and regulatory writing conveying safety, regulatory, and clinical summary information. Although scientific and regulatory writers often write across a variety of therapeutic domains, subspecialty trained physicians may have the potential to use their extensive knowledge and training to consult or work for a research or pharmaceutical company with a focus in their subspecialty. As much as writers in these positions are afforded time alone for the actual writing process, there is a lot of collaboration with individuals in other fields. This may not be the field for someone who prefers to solely work alone. A large part of this job is synthesizing reports and summaries from raw data; therefore, those who fear statistics or piles of data may not find this job enjoyable.