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Transitioning Between Medical Writing and Regulatory Affairs in a Contract Research Organization

Posted 21 August 2019 | By Kate Forte, MSc 

Transitioning Between Medical Writing and Regulatory Affairs in a Contract Research Organization

This article discusses transitioning from medical writing to regulatory affairs within a Contract Research Organization (CRO). Both roles are summarized and the similarities and differences between these two areas discussed. The author highlights why one might want to make the change in either direction and from her own transition experience, offers helpful hints for success.

Introduction

In the pharmaceutical industry, working in the regulatory field offers many possibilities for horizontal career changes. Depending on one’s experience and goals, one may be able to fit into any number of niches with many opportunities to move between different areas of focus, even without specific experience in the area you may be interested in entering. I made the transition from medical writing for individual studies to regulatory affairs, where I now look after products worldwide. The move was a little scary, but it worked.

The Beginning: Medical Writing

There are two main divisions within medical writing—regulatory medical writing, which is the subject of this article—and medical communications, which is more involved in “deliverables,” such as scientific articles and, accordingly, will not be discussed here.
 
On my first day as a medical writer, I was told medical writing is about three things: clarity, consistency and an “unhealthy obsession” with grammar rules. A medical writer can be involved at both pre and postmarketing stages and also may be involved at the study level, including the authoring clinical study protocols, Clinical Study Reports (CSRs) and safety narratives. The medical writer also may work at the product level, including the authoring of Development Safety Update Reports (DSURs)/annual reports, and Period Safety Update Reports (PSURs). There is great scope within medical writing, whether one wants to either specialize in one or two document types (such as CSRs or DSURs) or have a broader range of experience.
 
Clarity of writing and thought is important to the task. You need to be able to get your point across clearly and using plain language, even if the document you are writing is for a regulatory authority who might not be an expert in that specific therapeutic area or drug class you are writing about.
 
Consistency also is required. If you use inconsistent terms or phrases, you may confuse the reader and risk their misunderstanding. For example, switching between “subject” vs. “patient” may give the impression you are referring to two separate groups when you are not. It is also a much more pleasant experience to read a consistently worded document.
 
Listening and persuasion are key skills. The ability to listen to a client and understand what they want and “where they are coming from” is critical. Ask questions and persuade them to accept your viewpoint if you are suggesting a better or more effective way to perform a task. For example, you may have to convince a client that a 10-page, prior medications table may be better placed post-text with an in-text reference rather than in-text.
 
Become adept at “expectation management.” Clients often have very high expectations of what can be done in a certain allotted time period. Part of medical writing is knowing when timelines are too short or there is too much for one writer to handle. Being able to discuss this openly with clients is important. For example, honestly explaining why trying to turn around a CSR within two weeks will negatively impact quality when a normal process takes 30 days plus. If you are reasonable in your objections, you can find middle ground.
 
Mediation is important. Client teams will have disputes and you may have to manage clients through them. For example, whether a particular series of figures belongs in-text in a CSR or in a post-text may be an issue. Allowing all parties to air their opinions or concerns is important, but you also have to be able to offer your own opinion and come to a mutually agreeable decision. In the previous example, the issue was resolved by explaining that a hyperlink would be placed in-text so that readers could immediately access the figures.
 
Project knowledge and management are critical. Organization and time management skills are necessary to get source documents and other support materials you need to get the work done accurately and within timelines. One also needs knowledge of the project, the therapeutic area, the client and internal teams, the contract and all relevant guidelines to be followed, which are usually the International Council for Harmonisation (ICH).

The Change: Regulatory Affairs

I was not sure what to expect when I started working as a global regulatory affairs associate as I had no previous experience. Regulatory affairs supports the global lifecycle of a pharmaceutical product, preparing submission packages based on information provided internally by local regulatory affairs or by pharmaceutical clients. Coordination and information management is a large part of the job, with deliverable types ranging from the rollout of company core data sheet updates to relevant countries, to new marketing authorization applications. What I have learned is the position involves balancing a variety of different tasks. For example, to complete a variation submission requires authoring or requesting submission documents, creating the package, liaising with local RA and the client, making sure internal teams to get the required information, coordinating the final submission via the required pathway (specific country requirements or central such as the Central European Submission Portal), following up with stakeholders at all stages to track progress, meeting internal and external timelines and carrying out the maintenance of client/internal systems for tracking submissions.
 
Many of the skills are complimentary to medical writing, but the required knowledge is somewhat different. For regulatory affairs, one needs an in-depth knowledge of regulatory guidelines or at least a knowledge of where to find them. ICH Guidance, Eudralex Volume 2: A, B and C, the Quality Review of Documents Template, Coordination Group for Mutual Recognition and Decentralized Procedures Guidances are all available resources. They provide solid grounding in the basics of regulatory affairs and valuable source for new and seasoned regulatory affairs professionals.

A Comparison

Within the CRO world, both roles are a contracted service. In my experience, medical writing and regulatory affairs interacted only situationally when requesting or delivering safety deliverables (DSURs, PSURs, risk management plans, etc.) for submission. But this may not always be the case.
 
While the two roles are similar, as they require meetings and interactions with clients and other internal or external parties, management of expectations, attention to detail, patience and strict adherence to guidelines and regulations, there are some key differences. Medical writing generally consists of multiple individual deliverables. You can have a series of related documents (such as linked CSRs or a DSUR program), but they will be mostly self-contained with “lessons learned” between documents in a program. For example, a mistake in analysis in one CSR probably does not impact an upcoming CSR and, if it does, there is generally time to correct it prior to CSR drafting. Regulatory affairs is much more interconnected, where a change or the discovery of a mistake in one document, a summary of product characteristics/product information missing a contraindication, for example, can cause problems across all submissions for that product, resulting in the need for the submission multiple variations across multiple countries.
 
However, clarity of writing, consistency, listening, asking, persuasion, expectation management, mediation and project knowledge and management skills—all gained as a medical writer—will be of benefit in a transition to regulatory affairs because of the similarities between the roles as outlined above. Clarity and consistency will assist the client and the health authority assessors in reviewing and understanding the submitted documents. The ability to listen, ask questions and persuade will enable you to see your client’s point-of-view, but also to offer suggestions if, for example, you feel that the variation type selected for a submission is incorrect. In that instance, it would be your job to explain your position, using evidence from the variation guideline. Expectation management and mediation will help when there is disagreement within or across clients or internal teams (for example, on what variation type to choose for a submission). Project knowledge and management will give you confidence both to provide suggestions and assure the deliverable is on track. Once the regulatory affairs specific knowledge is in place (EMA guidances, etc.), these skills could be highly transferable when interacting with clients, especially in the preparation of documents such as clinical overviews and in the actual variation submission process.

Summary

The regulatory field is very open to movement within different areas. It allows a new entrant or even an “old hand” to either dive deeper and deeper into a specific area to become an expert or to move around and build a broad base of experience. I have found challenges moving from medical writing to regulatory affairs, but this change has given me a more holistic insight about where medical writing fits into the lifecycle of a product and how it and regulatory affairs complement one another.

About the Author

Kate Forte, MSc, is a senior regulatory affairs associate at Parexel. She can be contacted at Kate.Forte@parexel.com.
 
Cite as: Forte K. “Transitioning Between Medical Writing and Regulatory Affairs in a Contract Research Organization.” Regulatory Focus. August 2019. Regulatory Affairs Professionals Society.

Tags: careers

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