Looking to be part of the freelance revolution and gig economy? Here’s Kolabtree freelancer Sonika Verma to take you through the steps involved in becoming a qualified freelance regulatory medical writer.
Regulatory medical writing is a highly specialized area that comes under the broad umbrella of medical writing. It requires a perfect amalgamation of biomedical science, research, and writing skills. If you are proficient in one of these and have a passion for the other two, this article is for you.
Table of Contents
My Career Journey
Let me introduce myself briefly – I am Dr. Sonika Verma, and I’m delighted to be able to share a brief account of my professional journey with you. I completed my post-graduation in Ayurveda (MD) from Gujarat Ayurveda University, Jamnagar, in 2002. I have been working as a Freelance Regulatory Medical Writer since 2019. My first love was research – hard-core clinical research (as an investigator because I was unaware of other roles in the field), the sole motivation for pursuing post-graduation. But, unfortunately, at that time, it was hard to get clinical research training in India. It was given little space even in the curriculum of the medical colleges except a few, which were the preferred choice for whatever clinical trials were being conducted in India. Therefore, one could find very few focused and structured training programs/workshops on clinical research in the country.
I joined as an “Ayurveda Expert” in the Traditional Knowledge Digital Library (TKDL), an initiative undertaken by the Ministry of AYUSH and the Council of Scientific and Industrial Research (CSIR) for digitalizing traditional medicine formulations to protect their biopiracy and unethical patents. But my search for coursework/training on clinical research methodology continued till I found a distance learning course – “Industry Diploma on Contract Research and Clinical Trials” offered by the Bioinformatics Institute of India, Noida. Shortly after completing the diploma, I got an opportunity to work as a Research Scientist in the Indian Council of Medical Research (ICMR) headquarters, New Delhi. I am sure that I stood out from the crowd in the selection process because of this diploma.
My primary job responsibility in ICMR was to create all the clinical trial-related documents for conducting the safety and efficacy clinical trials of the traditional AYUSH formulations under a project primarily funded by the Ministry of AYUSH. One of my supervisors, who happened to be a member of the Investigational New Drug (IND) Committee, asked me to help him review IND applications submitted by the industry for permission to conduct clinical trials on new drugs. Naturally, I jumped on this opportunity. On special request, I was also permitted to attend the meetings of the IND Committee held in ICMR. At that time, I hardly had any idea that my work profile fulfilled the definition of a regulatory medical writer. Incidentally, Jamia Hamdard, New Delhi, started a Post Graduate Diploma in pharmaceutical regulatory affairs through distance learning. I enrolled in the course and got formal coursework to learn the fundamentals of the field along with hands-on training in official hours. Thus, my five-year tenure in ICMR provided me extensive exposure to regulatory medical writing.
During my subsequent stint at The INCLEN Trust International, New Delhi, I had a good time learning epidemiological research, data analysis, and scientific writing, including project reports, manuscripts, and grant proposals. In addition, being a project lead and principal investigator, I sharpened my project management and leadership skills. Lastly, my previous work experience as a full-fledged medical writer in a nutraceutical company almost completed my medical writing competency framework. Thus, now was the best time for me to venture into the field of freelance regulatory medical writing. Furthermore, the present covid-19 pandemic has made it imperative to get established in this niche. The pandemic has provided a “NEVER BEFORE” opportunity for freelancers.
The Drug Development Process
Before diving into the details of regulatory medical writing, let me briefly describe the drug development process. The drug development process starts from identifying /discovering a chemical entity to its marketing approval as a drug used in humans for a specific purpose and post-marketing safety surveillance. Drug development is quite an expensive and time-consuming process. A similar approach is followed for marketing approval of medical devices and animal drugs. It involves decades of research work, documentation, regulatory permissions, and clearances to finally arrive at a product that has an acceptable safety and efficacy profile for use.
Regulatory Medical Writing
Regulatory medical writing pertains to developing a set of standard documents (regulatory dossier) as evidence in support of quality, safety, and efficacy of a product required to be submitted by an applicant to the appropriate regulatory authority for seeking clinical trial or marketing authorization of the product to be sold in the market for its intended use. These documents should comply with the applicable regulatory guidelines.
Let me now explain the bold and underlined expressions one by one.
- Regulatory dossier: The contents of the regulatory dossier depend on the stage of the drug development or the type of application, i.e., (i) Investigational New Drug Application (IND) submission for initiation of clinical trial phase – for seeking permission to conduct different phases of clinical trials, (ii) New Drug/Marketing Authorization Application (NDA/MAA) submission at the end of clinical trials –- for marketing approval of the product, (iii) Abbreviated New Drug Application (ANDA) – Bioequivalence studies for generic drugs, (iv) Biologic License Application (BLA) – for marketing of biologicals, and (v) Medical Device Approval Application (as per the class of medical device).
Based on the drug development stage, the dossier includes all the procedural documents of preclinical, toxicological, and clinical studies, approvals from all the regulatory bodies for the conduct of both animal and human research, chemistry, manufacturing, controls, and packaging/labelling of the finished product.
Nowadays, most regulatory bodies worldwide have started/initiated electronic submissions of the documents to make the process fast and eco-friendly.
- Product: “Product” encompasses drugs, biologicals, biotechnological products, dietary supplements/nutraceuticals, and medical devices.
- Applicant – An industry like a pharmaceutical/biotech company, medical device manufacturer, or a research institution/organization (in case of Investigator-initiated clinical trials) may be an applicant for the regulatory submission. After getting market approval, these are designated as “Marketing Authorization Holder” (MAH).
- Regulatory authority: It refers to country-specific regulatory bodies like the United States Food and Drug Administration (US FDA), USA; European Medicines Agency (EMA), European Union; Therapeutic Goods Administration (TGA), Australia; Health Canada, Canada; Central Drugs Standard Control Organization (CDSCO), India to name a few.
- Clinical trial approval: Regulatory approval is mandatory before initiating a product’s clinical trial, irrespective of the phase.
- Marketing approval: Regulatory authorities provide approval to market a product after reviewing safety and efficacy data generated by the clinical trials.
- Market: “Market” refers to the market within-country of origin of the product or market in another country. The regulatory submission should comply with the guidelines prescribed by the applicable regulatory authority for that particular market.
- Regulatory guidelines – These are guidance documents developed by the regulatory bodies for guiding the industry throughout the entire review and approval process—for example, FDA guidance documents, EMA guidelines, ICH (International Conference on Harmonisation) safety, efficacy, and quality guidelines.
- Intended Use: It encompasses the prevention, treatment, or diagnosis of a disease condition.
Some of the examples of standard regulatory documents for drug approvals are –
- Preclinical study reports
- Clinical trial protocols
- Investigator brochure
- Informed consent forms
- Institutional Review Board (IRB) / Institutional Ethics Committee (IEC) approvals
- Clinical study reports
- Drug Master Files
- Adverse Event Reporting Forms
In medical devices, the class to which a medical device belongs decides the type of regulatory submission. For example, European Union Medical Device Regulation (EU MDR) requires the applicant to submit the following technical documents –
- Device description and specification, including variants and accessories
- Labeling information
- Design and manufacturing information
- General safety and performance requirements
- Benefit-risk analysis and risk management
- Product verification and validation, including preclinical data and clinical evaluation report (CER)
- Post-marketing surveillance plan
The work of the regulatory department does not end with marketing authorization of the product; instead, it opens the door to another part of regulatory submissions – post-marketing safety surveillance or Phase IV or pharmacovigilance.
Post-marketing safety surveillance is the active surveillance of the adverse effects of the medicinal products, which could not be anticipated in controlled environments of clinical trials involving a few thousand patients. Regular safety monitoring of the marketed product is required to complete the product’s safety profile. The marketing authorization holder must submit Periodic Safety Update Reports (PSURs) to the regulatory authority at standard time intervals. The information generated through this surveillance exercise may lead to a change in (i) warnings on the product labels, (ii) indications for the use of the drug, (iii) regulatory status of the drug, like over-the-counter (OTC) to a prescription drug, and (iv) withdrawal of the drug in case of risk overweighing benefits of the drug.
Educational Credentials Required
After this brief but enlightening glimpse into the world of regulatory writing, let us discuss what educational background a quintessential regulatory medical writer needs to possess. We have learned that sound knowledge of medical/biological terminologies is necessary for this profession. Hence, a bachelor’s degree in medical/health sciences, pharmacy, biomedical sciences, life sciences, biotechnology, or nutritional sciences is the minimum required for regulatory medical writing. However, a postgraduate degree has its own added advantages. It provides specialization/subject expertise and introduces you to research methods and scientific writing through your postgraduate research project.
The qualification mentioned above is of little help if you have not supplemented it with an internship or hands-on training in the industry for at least one-two year after completing your studies. Many pharmaceutical/biotech companies and contract research organizations recruit freshers as a trainee for their short-term projects. In addition, sometimes academic institutes have collaborations with the industry for student training programs. And if you are enthusiastic enough, you might have utilized your summer training opportunities during your course work to the fullest to get the feel of the work and place.
By this time, if you have already made up your mind to join the regulatory workforce, start self-study – reading technical guidelines and other resources available on the websites of the regulatory bodies worldwide and pursuing online free training courses like Good Clinical Practices (GCP). Next, get yourself placed in the medical writing team (under a good mentor if possible) of the regulatory department of industry or academia and work there for at least two years so that you may become eligible for further certifications.
Professional certifications from any of the accredited associations like Regulatory Affairs Professional Society (RAPS), Association for Clinical Research Professionals (ACRP), American Medical Writers Association (AMWA), European Medical Writers Association (EMWA), or International Society for Medical Publication Professionals (ISMPP) is in demand these days. It enhances your credibility, demonstrates your dedication and a keen interest in the field. It also provides you an edge over your competitors while getting promotions for a senior role. Also, grab opportunities whenever available to attend workshops and conferences to get information on the latest developments in the field. Regulatory medical writing is highly structured, template-driven, and strictly guided by federal regulations. Therefore, keep yourself abreast of all the technical guidelines, both released and upcoming. In addition, learn as much as possible about the sister fields of regulatory writing like statistics, project management, English language, and grammar. Practice regularly to improve your writing skills and join some free online courses to learn about scientific writing. Finally, be proficient in using MS word, search engines, referencing styles, and reference management software like Mendeley, EndNote, or Zotero.
What makes a great regulatory writer?
Every professional job requires a set of essential soft skills to achieve success in that field. A regulatory medical writer should have a knack for clear, concise, and consistent communication within the department and other allied departments. S/he should be proactive, display leadership qualities, conflict resolution ability, and good negotiation skills. S/he should think logically, has an eye for detail, adhere to deadlines, and demonstrate exemplary work ethics and integrity. A distinguished medical writer is a good team player, a life-long learner, and an excellent mentor.
There is no dearth of full-time positions for a competent regulatory medical writer. They are absorbed in – pharmaceutical/biotech/medical device industry, Contract Research Organisations (CROs), medical research institutes, academic institutes, scientific research publication houses/journals, online regulatory and healthcare portals, and freelancing. Freshers get entry-level positions like research assistant/associate. In due course, their experience and performance earn them senior-level positions like a medical writer, senior medical writer, followed by the project manager, senior project manager, and department head. Also, regulatory medical writers can play the roles of clinical data analysts, liaising officers, reviewers, and editors as per their strengths. Over time you may develop your specialization/expertise in a particular product like biological or a drug or medical device; therapeutic area like oncology; or document like clinical study reports.
The Risk-Reward Ratio
You must be wondering when I would discuss becoming a freelance regulatory medical writer. NOW is “the time”! You have developed enough expertise and have a fair idea of doing the job, so welcome to the world of freelancing. However, keep in mind that learning continues for a regulatory medical writer to keep himself updated on the ongoing developments in the field by regularly visiting the relevant websites. Freelancing has its pros and cons. It gives you the flexibility of work hours, work-life balance, freedom to choose a project according to your interest and expertise, and reasonable remuneration. In other words, you are your own boss. However, the disadvantages are the inconsistent workflow, no employer benefits like health cover or insurance, and sometimes not getting paid. In addition, medical writers are usually ghost-writers, i.e., they do not get a place in the list of authors even after contributing significantly to writing the document. It happens most of the time if you are freelancing. So always keep this fact in mind, and if it bothers you, then freelance writing is not for you.
How to become a freelance regulatory writer
To start with, read some good articles on freelancing and list down the freelancing websites. Then, go through each website, carefully read their terms and conditions, look at the types of projects available, and evaluate their payment method. Finally, shortlist one or two relevant websites and register yourself. You may need to build your profile there. Choose the proper keywords to highlight your profile so that you may get in the right search. Select verified clients and ensure that project gets funded before starting any work. Also, in the proposal, while writing the scope of work, divide your assignment into multiple activities and quote the price for each activity separately so that you may get paid as you work. You may need to sign non-disclosure/copyright agreements with the client as the assignments may be confidential and involve intellectual property.
Networking is an essential skill for freelancing. First, you need to develop your professional network while working full-time. I hope you quit your full-time job gracefully under any circumstances. After all, you might get a chance to freelance for the same employer as they are aware of your strengths and work ethics as I worked for the same company as a freelancer for almost a year because they could not find a suitable candidate for the position. Second, join the local chapter of relevant professional bodies and become their active member. This network helps you in getting assignments when you start your career as a freelancer. Finally, create an online portfolio at networking sites like LinkedIn to showcase your talents and skills to attract potential clients.
Here are some tips for winning bids and earning excellent client feedback on online freelancing portals –
- Bid for those projects where the clients are clear about their requirements. It saves your time from sending queries to those who are a little confused about the job/freelancer profile they need.
- Highlight your relevant skills and experience in the bid proposal.
- BE HONEST about the scope of work and the deadlines. Knowledgeable clients are well aware of how much workload and time is required for the project.
- Ask about the background of the primary contact person on the client’s side. Many a time, the primary contact person has little or no knowledge about the field. It usually happens in case the client is a start-up or a newly found entrepreneur. To avoid confusion, discuss the scope of work and deadlines with the appropriate personnel or explain all the technical details in simple words for better comprehension. BE PATIENT because you may need to explain some important facts and figures repeatedly.
- Some clients feel pleased if you share and discuss the documents you refer to while working on the project. They prefer to go through those documents to make informed suggestions for iterations. Also, it assures them that they have hired a knowledgeable but humble person.
- REGULARLY UPDATE the clients about work progress. In some cases, you can use google docs and share it with the clients to monitor real-time progress.
- FOLLOW COMMUNICATION ETIQUETTE throughout the project duration. It leads you a long way in establishing good terms with the clients and winning future projects from the same clients.
- With your vast experience in the field, sometimes you may suggest small iterations that do not come under your scope of work but are very useful for improving the outcome, be it a product or a document. If you are sure enough, discuss your observations with the client. It shows your keen interest in their project and makes you win their confidence and more projects too.
On the other hand, if you are not comfortable with any aspect of the project that was not a part of the proposal, you can put it forward and politely inform that it is out of the scope of the current project. Professional clients appreciate it and may create a new proposal for you to work on further. It happened to me in my previous project.
- Calculate and quote your fee wisely. I have mostly worked on fixed-fee projects to date. However, according to my experience, an hourly fee is more appropriate for short-term consultation or discussion. It becomes easier for both the client and the freelancer to count the work hours.
You are now well-equipped. So READY, STEADY, GO!
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