Medical writing is among the fastest emerging career paths in the life sciences, pharmaceutical, and clinical research realms. As individuals trained in medicine, pharmacy, or life sciences often learn, however, the discipline is less easy to define. Medical writing in pharma is a very broad term for the field and is composed of multiple subcategories that demand different skills from the individual and different career pathways. Here, we concentrate on regulatory medical writing, one of the most structured and sought-after areas. In this blog, we will discuss the definition of regulatory medical writing, its scope, its purpose, the types of documents prepared, the different types of careers available, salary scales, as well as how it compares to other forms of medical writing. We will also explore which forms of medical writing can be remote, freelance, or working on-site.
What is Regulatory Writing / Regulatory Medical Writing?
Regulatory medical writing in pharma refers to writing documents that are submitted to regulatory authorities (e.g., FDA, EMA, CDSCO, MHRA) in conformity with regulatory ISO process requirements for approval of a regulatory submission (narrative-based approval) and after (i.e., pharmacovigilance-based and requirements). These documents can be from pre-clinical to real-world pragmatic studies to post-marketing surveillance documents. Some documents may include, but are not limited to, protocols, clinical study reports (CSRs), investigator brochures (IB), regulatory submission dossiers (IND, NDA, MAA), integrated summaries (ISS/ISE), and pharmacovigilance reports.
It is crucial for regulatory writers to have a solid foundation in clinical trial methodology and statistics (especially descriptive statistics), pharmacology (including pharmacovigilance), as well as understanding the process of ethics, and adhering to regulatory guidelines, or working with cross-functional teams or departments – e.g., clinical development, regulatory affairs, biostatistics.
Purpose and Scope of Regulatory Medical Writing
The principal objective of regulatory medical writing in pharma is to provide regulatory standards, facilitate transparency in conveying data, and provide patient safety. Thoroughly developed and well-written documents mitigate the risk of regulatory delays, denials, and efficacy issues, provide assistance for inspections, and assure an efficient product lifecycle.
The scope of regulatory medical writing encompasses the life cycle of the product:
- Preclinical/early development: Protocols, IBs, nonclinical study reports
- Clinical regulatory writing trials: CSRs, safety updates/informed consent forms
- Regulatory submissions: The CTD/esCTD dossier Bureau of Staffing and Non-Translated Dockets ISS/ISE Summaries
- Post Approval: Pharmacovigilance reports periodic safety reports, and documentation for new indications or changes within the product
Regulatory Submission Documents & Key Types
These are the documents a regulatory medical writer would typically be involved in:
Guidelines, Regulations & Harmonization Bodies
To do regulatory writing services properly, you need to understand the relevant guidelines. Important ones include:
- ICH (International Council for Harmonisation): guidelines such as ICH E3 (CSRs), ICH M4 (CTD format), ICH E6 (Good Clinical Practice), ICH E8 etc.
- Country/regional regulatory agencies: e.g. FDA (USA), EMA (Europe), MHRA (UK), PMDA (Japan), TGA (Australia), Health Canada etc. Each has local requirements or deviations.
- Good Clinical Practice (GCP): ethics guidelines, informed consent guidelines.
- CTD / eCTD format guidelines for structure, modules, electronic submission standards.
- Regulations / guidelines: dealing with pharmacovigilance, safety reporting (e.g. ICH E2 series) and post-approval changes (ex: ICH Q-series for CMC).
How to become a regulatory medical writer- Career Path and Required Skills
A regulatory medical writing career usually begins with a background in life sciences, pharmacy, medicine, or another related field. While not always required, advanced degrees (MSc/PhD) may be preferred for therapeutic areas with a high level of specialization. Basic knowledge of clinical research, biostatistics, pharmacology, and regulatory guidelines (ICH, GCP) are looked upon favourably.
A junior writer role may involve: summarizing data provided by authors, inputting those data into report templates for later drafting, drafting sections of reports, aiding in quality checks, learning the review process, etc. More experienced writers may be responsible for an entire submission, mentoring junior writers, and leading a team in the preparation of a large submission dossier – one that has sections authored by multiple authors.
The following characteristics will impact career advancement:
• Technical understanding of clinical/nonclinical/safety data
• High competency in the areas of writing, editing, and structuring documentation
• Attention to detail and quality control
• Project management skills – timelines, estimates, coordination, version control
• Soft skills; communication, adaptability, collaboration, and diplomacy
Training and certification in regulatory writing, clinical research, reading and understanding pharmacovigilance, and ICH guidelines, can improve career advancement opportunities. Constantly developing experience in cross-functional areas such as biostatistics or regulatory affairs would also provide some benefit when looking for career advancement opportunities
Salary, Industry Outlook, and Employers
Regulatory writing services is an area that is exploding in the wake of increased clinical trials, heightened regulatory scrutiny in markets worldwide, and increasing demand for high-quality submission writing. Compensation is more than competitive with other medical writing activities and reflects the complexity and regulatory accountability of this work.
Regulatory Writing vs Other Medical Writing Domains – Career Transition
Regulatory medical writing in pharma is quite different from the other areas of medical writing. Scientific writing texts are primarily focused on the journal or conference publication process and examining the novelty and interpretation of the data for a review board that is composed of a scientific audience, as opposed to a regulatory audience. Medical or health marketing type writing is even less technical and less of an obligation, as promotional materials, educational content, or patient brochures, are considered marketing. Medical communications type writing often includes less formal, less technical and less data driven writing like continuing educational opportunities or literature reviews as opposed to regulatory writing. You can thoroughly transition from scientific or marketing writing to become a regulatory writer. Courses in clinical research, pharmacovigilance, and/or ICH guidelines would be very beneficial for your career trajectory and immediate development in this space. Taking training in regulatory writing literature, familiarizing yourself with several kinds of regulatory-type documents, battening down your knowledge of regulations (ICH or otherwise), and being familiar with protocols and clinical study reports (CSRs). Medical writers have strong writing skills already, and the majority of the jump into regulatory writing services is building the knowledge, precision and familiarity of clinical data and safety data. Upon successfully completing the preparatory work, many organizations will often consider you for entry-level regulatory writers; and therefore, this is a reasonable transition and progression for you, and it is a logical career advancement.
Conclusion
Regulatory medical writing in pharma is a disciplined, demanding, and rewarding career with opportunities around the world. Regulatory medical writing combines science, regulations, writing, and collaboration. If you are just starting out or moving from scientific or marketing writing, domain knowledge and education ultimately allow you to build a successful career in regulatory writing. Regulatory writing is growing, has competitive salaries, a variety of assignments and opportunities, and both securities and advancement in your career.
FAQs about Regulatory Medical Writer
1. What is the role of a regulatory medical writer?
A regulatory medical writer creates documents, including protocols and CSRs, CTDs, and pharmacovigilance reports, to submit to organizations like FDA or EMA. They ensure that medical regulatory documents are clear, accurate and comply with international regulations.
2. Is it possible to transition into regulatory medical writing from a different medical writing arena?
Absolutely. Writers from a scientific or marketing background, or from medical communications, can become regulatory writers by gaining some knowledge of clinical research, pharmacovigilance, ICH/GCP guidelines and writing regulatory documents like CSRs and CTDs.
3. What are the differences between regulatory medical writing and other types of medical writing?
Regulatory writing is compliance-focused, and focused on regulators, scientific writing is focused on researchers, medical communications is focused on healthcare providers, and marketing writing is targeted for patients or providers. Regulatory writing is the most structured and data-driven field.
4. Is it possible to work remotely or on a freelance basis for regulatory medical writing?
Yes. Many companies and CROs hire experienced freelance or remote regulatory writers to write CSRs or safety reports, though for some large submissions, regulatory medical writers may have to be onsite to collaborate with company personnel.
5. What skills should I develop to be successful as a regulatory writer?
Writing well, paying attention to detail, knowing about clinical research and regulations or guidelines, and working with various teams from different fields are all very important for growing your career as a writer.
