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Medical writers who can produce high quality work to tight deadlines are currently in great demand. Traditionally many different people within research and marketing departments wrote the documents that are now being written by medical writers. For example, a Clinical Research Associate was often expected to write, not just the study protocol, but also the investigator brochure, clinical study report and manuscript for publication. This frequently meant that preparation of at least some these documents was given low priority, because of more pressing tasks associated with running clinical trials.
In today's highly competitive pharmaceutical business, new drugs must be approved rapidly by the regulatory authorities and marketed effectively. As a consequence, drug development must be focussed and efficient, and marketing strategy and promotional materials must be in place at an early stage. This is where a medical writer can offer an invaluable service by providing high quality documents to specified timelines whilst freeing up other professionals to concentrate on different aspects of the job.
What do Medical Writers Write?
The documents that a medical writer may be asked to prepare can be divided into two broad categories - 'Regulatory' and 'Marketing/Other'. 'Regulatory' documents are those that are submitted to, or fulfil the requirements of, regulatory authorities at various stages of drug development. 'Marketing/Other' documents are those that are used for marketing or more general purposes. Examples of the documents that fall into these categories are shown below:
Regulatory
Protocols
Patient information leaflets/package inserts
Clinical study reports
Efficacy and safety summaries
Clinical expert reports
Summary of product characteristics
Safety updates
Investigator brochures
Marketing/Other
Manuscripts for publication
Literature reviews
Abstracts and posters
Conference proceedings
Product monographs
Training material
Slide kits
Advertising material
What Qualifications and Qualities are Required?
No specific qualifications are required for medical writing but normally a medical writer would have a life science degree and sometimes a further degree. Often medical writers have previous experience in drug discovery or clinical research but there are also opportunities for new graduates. In addition to these basic requirements, certain personal qualities and abilities are needed.
Good language skills are very important. This does not mean that you must be able to write complex sentences filled with long words but that you must be able to convey the message to the reader in a clear and concise way.
As a writer you must have the motivation to see the job through. No matter how good a job you have made of the first draft, inevitably there will be comments from reviewers resulting in one or more re-drafts. So you must be prepared to take criticism. You may also find that you work hard to meet a deadline and then have to wait patiently for weeks for reviewers to provide their comments. Some of the comments you receive may be very frustrating, particularly when they relate to writing style or are a complete reversal of what you were asked to include in the previous draft. This is all part of the job!
Attention to detail is essential to ensure the accuracy and completeness of the document. However, this must also be balanced by an ability to extract key messages and data from a large volume of information. For example, the statistical tables and listings generated for a study report can be extensive and it will be your role to identify the key points and present them in a clear and readable form. Attendance at conferences and preparation of reports on the proceedings are particularly enjoyable aspects of a medical writer's job but again skill is required in summarising large amounts of information.
It is also vital to know the audience and pitch the document at the right level. A Phase III clinical study report is a comprehensive presentation and discussion of the methods and results of the study. It is often over 100 pages in length and will be submitted to the regulatory authorities. This is very different from a short manuscript on the same study, which is for a wider scientific and medical audience, yet must contain the same key data and messages.
You may be asked to prepare training material on a particular drug and therapeutic area for a sales force with no experience in the area. This must provide the sales representatives with sufficient knowledge for discussions with health professionals but should not contain excessive technical detail. Preparation of patient information leaflets, on the other hand, requires a completely different approach. These are aimed at people from wide variety of backgrounds and educational levels but must be fully understood by all. It is so easy to forget that much of the terminology that we use on a daily basis is incomprehensible to most of the general population. So you shouldn't assume that everyone knows what an analgesic is!
You must also be willing to accept that you will often be expected to 'ghost write' documents and, therefore, your name will not appear in print. This obviously applies to the preparation of clinical expert reports where you will work closely with the clinical expert who will sign-off the document. However, it is also often the case with many other documents, including manuscripts for publication where you are unlikely to appear as a co-author or even receive an acknowledgement. The satisfaction is in seeing your work in print and knowing that it is a job well done.
Medical writers seldom work in only one therapeutic area. You will not have the time to do a lot of background reading before starting a writing project in a new area but must be capable of 'hitting the ground running'. The varied nature of work, however, makes the job more interesting and at the same time gives you the opportunity to broaden your knowledge.
Where do Medical Writers Work?
There are opportunities for medical writers to work in pharmaceutical companies, contract research organisations (CROs) or medical communications agencies. In addition, government bodies such as the National Institute for Clinical Excellence (NICE) employ medical writers, and many freelancers also provide medical writing services.
Is a Career in Medical Writing for You?
If you are capable of working independently and would gain satisfaction from getting to grips with large amounts of data and communicating the messages effectively to different audiences, then you would find medical writing to be rewarding. If, however, you are someone who enjoys getting out of the office, foreign travel and interaction with lots of different people during the course of the working day then medical writing is probably not for you.
In considering a medical writing career, you should decide what type of writing you wish to do, as this will affect where you choose to work. In a pharmaceutical company or CRO you are more likely to prepare detailed, technical documents in the 'Regulatory' category and will have to follow templates and regulatory guidelines. If you work in a medical communications agency, however, you will probably prepare more manuscripts for publication and marketing documents that generally require a less structured and more 'creative' approach. It is worth noting, however, that some agencies now also have departments that prepare regulatory documentation.
So where can you find jobs in medical writing? The European Medical Writers Association (EMWA) advertises jobs on its website (http://www.emwa.org) and, in addition, provides a variety of courses in medical writing. Pharmaceutical recruitment consultancies deal with vacancies in medical writing and jobs are also advertised in New Scientist. Finally, don't forget that networking may also help you to find a suitable opportunity.
Copyright © 2009 PDR Partners, incorporating Bob Gammon Associates. |
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