Regulatory Writing – An Integral Part of Clinical Research

There are two main areas in medical writing, medical communications and regulatory writing. This blog focuses on regulatory writing, which involves the preparation of clinical study and regulatory submission documentation.

Generally, regulatory writers have a PhD in a life science, science-related or medical subject and may be freelance, or employed by sponsors (e.g., pharmaceutical/biotech companies) or clinical research organisations (CROs). 

Regulatory writers produce a wide variety of clinical documents throughout the life‑cycle of a (potential) treatment, starting with describing and reporting data from clinical trials, through to preparing regulatory submission documents. If the treatment is approved by a regulatory authority, regulatory writers also produce post approval reports on the use of the treatment in patients. Examples of clinical documents produced by regulatory writers most commonly include Investigator Brochures (IBs), Clinical Study Protocols, Clinical Study Reports (CSRs), and the Common Technical Document (CTD). The audience for these documents is usually regularity authorities and ethics committees. The key national regulatory authorities are:

• United States - Food and Drug Administration (FDA)
• Canada - Health Canada
• European Union - European Medicines Agency (EMA)
• Japan - Ministry of Health, Labour and Welfare Japan

Each authority assesses the efficacy and safety of drugs throughout the clinical trials process and ultimately approves the investigative drug/device/compound's use.

Importance of Regulatory Writing

The importance of preparing high-quality regulatory documents is often under estimated. A CSR is the final result of many months and sometimes years of hard work by study teams, and has to summarise the conduct and results of a clinical study in a clear and unbiased manner. A well-written CSR will aid the subsequent production of high quality submission documents, and conversely, poorly written or presented regulatory documents may lead to delays in regulatory approval, costing the sponsor time and money. 

In the ever-changing regulatory environment, experienced regulatory writers can add a lot of value to the production of clinical study documentation. As an integral part of the clinical research process, regulatory writers can act as a pool of knowledge at every step, from protocol development to the drug submission process. Regulatory writers are skilled at meeting global regulatory requirements and adhering to guidance documents such as International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), while still fulfilling the needs, preferences and styles of sponsors and/or study teams.  They understand, interpret, and summarise often complex scientific and statistical data whilst providing effective guidance to clinical study teams, which usually include experts from other fields such as clinical/medical, statistics, regulatory affairs, pharmacovigilance, and pharmacology. Some regulatory writers become experts in a particular therapeutic area or disease and can provide invaluable insights to the sponsors and/or study teams. Regulatory writers can also perform quality control (QC), peer review and provide other editorial support on documents produced by sponsors and/or study teams, if required.

Becoming a Regulatory Writer

Whether working for a pharmaceutical company or a clinical research organisation (CRO), most regulatory writers started out as academics.  Although a PhD is not a pre-requisite, most employers will be looking for a scientific or medical degree, not to mention certain character traits such as problem solving and analytical skills, fastidiousness and a readiness to embrace new fields of research.

Whether you are applying to regulatory writing from within or outside the clinical world, the first step is to familiarise yourself with the types of clinical trial documentation that exist:  for example Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).  Read some published clinical trial results; biostatistics is a big part of the job and a regulatory writer needs to be able to recognise and handle large volumes of various types of data including pharmacokinetic, pharmacodynamic, efficacy, and safety.  You must also become familiar with the whole process of drug development and regulation; familiarise yourself with clinical trial design eg, Phase 2 study design, the specifics of safety and pharmacovigilance reporting and Good Clinical Practice (GCP).  The following websites will be useful: United States Food and Drug Administration (FDA) (www.fda.gov), Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk) and European Medicines Agency (www.ema.europa.eu).

Next identify some potential employers.  An internet search for biometrics companies in the UK, pharmaceutical companies or CROs in the UK should provide a detailed list of regulatory writer vacancies.  There are also dedicated recruitment agencies.

Your curriculum vitae and covering letter must be perfect; there should be no grammatical or spelling errors, the document should be laid out clearly with no formatting errors.  Any science based work experience is valid, particularly if you have been involved in any laboratory based primary research.  Most pharmaceutical companies or CROs have specific therapeutic areas of interest and you should tailor your application to match this.  For those applicants without a postgraduate degree, describe any writing experience eg, blogs, and student newspaper or other published articles. 

In most instances, as well as an interview, you will be asked to complete a writing and/or a quality control test.  In both cases you must concentrate on accuracy, clear interpretation of data and consistency.  It doesn’t matter if you can’t use proofreading marks, or that you don’t know the standard way to display data; as long as you have captured mistakes, or clearly presented the most important data, your test will be looked upon favourably.

Quanticate offers a wide range of Medical Writing services including clinical and regulatory writing in support of any or all stages of the pharmaceutical development life-cycle. Our Medical Writers deliver accurate, timely and cost effective documents to the highest of ethical and scientific standards. Our team is trusted by top pharma and flexible in our ability to adapt to client systems and standard operating procedures (SOPs). Please submit a request for information (RFI) if you would like to speak to a member of our team who can support your trial.

Related Blog Posts:

• Becoming a Regulatory Writer
• Medical Writing Tips For Managing Multiple Priorities
• What Defines Quality in Medical Writing?

Authors note: This blog was originally published on 18/03/2011 and has since been updated.