Documents Needed by Medical Writers To Write A Clinical Study Report

Standard

Freelance medical writers often find themselves contracted by sponsors for writing clinical trial reports (CTR) also known as clinical study reports (CSR) even before all the required documentation is ready at the sponsors end. This causes delays in the completion of the clinical study report. In addition, delayed CTR completion can extend the actual submission date of the product’s eCTD/marketing application as clinical study reports are mandatory documents for the regulatory submission dossier. Every day by which the marketing application submission gets delayed, results in a considerable loss of revenue for the sponsor.

Completion of the clinical study report must be taken on a priority after study completion and all efforts must be put in to ensure that a clinical study report is finalized within a reasonable amount of time. This will not only reduce the cost of CSR development but also result in faster submission to the regulatory authorities.

Continue reading

Share

Medical Writing Interview Sample Written Test

Standard

We have discussed about about medical writers being put through a written test during medical writing interviews in many earlier posts. Here is a sample medical writing interview written test that you may be asked to do. Do not prepare this question only, rather look at it as a guide and practice many similar tests.

Downloading various free full-text scientific articles from PubMed or Science Direct and trying to rewrite them in your own way as per different referencing styles could be another exercise you could do to prepare for a medical writing written test. We have already discussed about various referencing styles in an earlier post.

DOWNLOAD THE Medical Writing Interview Sample Written Test HERE

Share

What is LEAN Writing? Three Steps To Get Your Writing In Shape

Standard

We live in an ever changing world that is fast-paced, technologically advanced, interconnected with almost no communication barriers. A wealth of information is thrown at us everyday by newspapers, magazines, websites, emails, sms, phone calls, social networking and what not, but all of us know that it is impossible to remember and act on all the information that we receive and process. So what do we as human beings do about it? How do we react to this? As more and more information flows to us, we become more and more selective. No one has time to read through pages of documents or read lengthy articles on the internet. We only scan through the information, look for the most important points or the highlights and move on!

With people moving from one piece of information to the next so rapidly, it is very difficult to get your message through in the most efficient manner. This is especially a challenge when the message is technical and the audience multi-lingual and multi-generational. Continue reading

Share

Why Referencing? Referencing Styles in Medical Writing:

Standard

Referencing is an essential part of any scientific document. A referencing style is a specific format for presenting your in-text references (footnotes or endnotes), and bibliography. There are many different referencing styles.

Use of referencing:

When a writer puts together a written report or when a speaker delivers a lecture, they are essentially presenting consolidated data and information obtained from a number of sources such as results from clinical trials, surveys etc. All these sources (articles published in scientific journals, statistics reported on healthcare websites etc) which are used by the writer or speaker are presented towards the end of the document or the bottom of each presentation slide. Continue reading

Share

Medical Writer – Writing Event Highlights / Meeting Summary:

Standard

In the previous post we discussed about how to prepare for and attend events from a medical writer point of view. Let us now, in a greater detail discuss about how an event highlights, also known as meeting highlights should be written.

Before we discuss how to write event highlights, let us look at its definition:

An event highlights is a summary of a presentation, talk, or lecture, containing text and visuals (such as graphs, charts or tables) illustrating complicated medical information in a simpler format.

Although on most occasions this type of writing is semi-promotional in nature and is used by clients to promote their products, it is the medical writer’s responsibility to make it informative for the audience. You must look up some good samples written in the past by your colleagues before getting started.

Continue reading

Share

Medical Writer: Things You Should Know When Attending Events

Standard

As a medical writer working in a pharmaceutical company or a contract research organisation most of the times your job responsibilities are not limited to writing. In fact in senior medical writer positions you function both as a writer and a project manager being responsible for completion of projects on time. On many occasions medical writers are required to attend events such as new product launch, lectures by eminent personalities, conferences, seminars etc so that an event summary (highlights) can be written to be made available to people not present at the event or for publication in any of the company newsletters, newspapers, magazines, journals etc.

Before you attend any such events, it is important that you prepare well, know in advance how to carry yourself and what points to make a note of during the event. Your company may already have a standard operating procedure (SOP) related to attending events, so if your company has one, read it thoroughly. If you are new to the company, it will act as a guide for you to do things right as per the expectation of your line manager or seniors. Continue reading

Share

What is Writer’s Block? Simple Strategies To Prevent & Overcome:

Standard

Most writer’s at some point in their lives face a writer’s block which is a loss of the ability to produce any new work. Instead of feeling energized and excited about getting started on a new assignment, the writer’s find themselves to be stressed, apprehensive and demotivated. Such adverse feelings make it difficult to get started, resulting in a writer’s block. The intensity of the condition varies from temporary to extreme. While temporary writer’s block in which the writer’s are unable to get started on one particular assignment is most common, extreme conditions may prevent them from writing for years and may even result in many of them giving up a career as a writer. Continue reading

Share

Hedging in Scientific Writing – Strategies & Techniques

Standard

The Oxford dictionary defines the word hedge as, ‘a fence or boundary formed by closely growing bushes or shrubs’. In writing, hedging refers to the use of cautious language to make noncommittal, cautious or vague statements. It allows authors to make decisions about their viewpoint on a particular subject or the strength of the claims that they are making.

In addition to several other reasons, hedging leaves open the option of retreat for the writer if required. In scientific writing this technique is used by writers to differentiate between ‘claims’ and ‘facts’, to safeguard themselves from chances of error and to report the limits of their findings. Although hedging is legitimate and commonly practised in scientific writing, it is important for writers to be aware of their hedges and to avoid using them in excess. Continue reading

Share

Steps in Writing Scientific Documents

Standard

A number of logical steps are supposed to be followed when we consider writing scientific documents, especially documents that are required by pharmaceutical companies (sponsors) for submission to regulatory agencies such as the US FDA, EMEA, MHRA, DCGI etc.

1. Understand your assignment well:
Writing a document is going to become much easier and less time consuming when the writer knows its importance, where it is going to be used and what for. Hence, invest a reasonable amount of time in knowing more about the document if you are not already familiar with it. Also, understand how much data is required to be studied, where it is available and any sponsor specific document review and approval processes that you need to follow. Continue reading

Share

Medical Writing Interviews! Improve Your Chances of Getting Hired

Standard

So you are all set for your medical writing interview and believe you have prepared enough to impress any interviewer. But yet, could there be something that you may not have thought of? Following the below mentioned simple steps and considering each of them as an important aspect of a successful interview will make your job interview more satisfying and remarkably improve your chances of getting hired. Although some of these steps may seem insignificant to you, they could in the eyes of an experienced interviewer be deal makers or deal breakers. All companies want to hire the best people and they are looking for reasons to not hire you. Don’t give them any and you will get the job. Let us now look at what you must focus on most, before, during and after any medical writing interview:

BEFORE THE INTERVIEW:

1. Ensure your cover letter and CV are impressive. Copies of all documents that you carry including your cover letter & CV must be pleasing to look at. They should have a professional look with proper formatting and must be error free. Any minor spelling or grammatical mistakes are enough to turn-off your interviewer and land a negative impression of you. Most experienced human resources professionals and senior medical writers state that poorly formatted cover letter and CV, in addition to grammatical errors are the most common reasons for not calling candidates to the interview desk even if they fulfill the qualification and experience requirements. If you have completed any medical writing training, do specify it clearly in your CV. Continue reading

Share