Medical writing is a special subset of technical writing that requires familiarity with medical and pharmaceutical terminology. It is an excellent niche for those writers with a scientific background.
And within the medical writing subset, regulatory writing is another specialty that pays very well since your employers are usually pharmaceutical companies that rarely have any cash problems.
To create the appropriate documentation in order to obtain regulatory agency approval for a new drug is the chief responsibility of a regulatory writer. To market and distribute a prescription drug one needs to have the regulatory stamp of approval of the Food and Drug Administration (FDA).
There are several types of specialized documents that you’d be asked to write as a regulatory writer. Here are the two most important of them all:
IND (Investigational New Drug Application). Clinical trials on human subjects cannot begin before this document is prepared following the conclusion of the animal tests. All the crucial information about the chemical and molecular properties and characteristics of the drug are expected to be included in this document. Plus, all the results of the tests with animals must be in there as well. All pharmaceutical companies operating in the U.S. market must submit an IND document to the Food and Drug Administration (FDA). Until the IND document is approved the drug company cannot market anything. Whether a pharmaceutical company will make millions or lose millions all depends on the approval process. So you can imagine the importance of the IND document.
NDA (that is, New Drug Application). This is a document that reports the clinical experiments conducted on human subjects. The NDA document is required before the drug’s final market release since it contains all the detailed chemical, physiological, and pharmacological lab data which shows that the product is safe for public consumption. Each year some drug companies are sued for providing defective information to the consumer public. To prevent that, regulatory writers interview all the experts and make sure every possible drug-related question is answered in this document.
Regulatory writers prepare other important documents as well, like CTD (Common Technical Document) and MAA (Marketing Authorization Application).
If as a technical writer you have any leanings towards medicine, biomedicine, and pharmacology, I’d strongly encourage you to explore this lucrative niche for your future career.
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How I Used The Fresh Papaya (PawPaw):
The fruit was to be consumed ‘As is’ because we always have a small plate of fruit everyday around 5 pm.
I planned on adding a teaspoon of seeds into my Yogurt at lunchtime.
The ‘Coleslaw’ I would add to any Salad (even in a sandwich) as it’s summertime in Oz and we are eating a lot of Salads. Don’t know what I am going to do in the Winter though? If you have any ideas please add them as a comment so everyone can benefit.
I had also planned on five serves per day because I thought it would be better to ‘Drip Feed’ it into me, as my wife thinks I am a ‘Drip’ sometimes anyway – so that should fit.
Now… Continue reading Prostate Cancer Diary - My Papaya Recipe
Monday 6th Feb 2012: My Prostate Cancer Diary.
So here is the problem. I have dismissed Surgery completly and that leads me to Radio Therapy as the only available conventional medical alternative.
My Oncologist want me to have Hormone Treatment to:
- a: Slow the Growth of the Cancer cells by (basically) chemically castrating me. Ouch!
- b: Shrink the Prostate down to a smaller target for his magic Death Ray.
I didn’t want to do that with Hormone treatment, but can appreciate why he wants to do that.
So I’m looking into all types of Natural and Alternative medications.
The best I have come up with is PawPaw (Papaya) as there have been quite a few studies with very promising reasults, PLUS it has been… Continue reading Prostate Cancer Diary - My Natural Alternative
Prostate Treatments and Me.
Long time coming since my last post – but I have been kinda busy…. Tests – tests and more tests 
So this is the latest:
My Urologist sent me to the Radio Oncologist because I decided I do NOT want surgery. Apparently I can’t have Brachyatherapy (my original choice) because my Gleason Score is 8 – too high, so External Beam Therapy is the only option, even though they only found cancer cells in ONE of the TEN Biopsies they took.
HOWEVER: (I am discovering LOTS of ‘Howevers’), the Oncologist wants me to have Hormone Treatment first to bring my enlarged prostate down in size.
An ‘Average’ prostate is about 40mm – about the size of a small Plum -… Continue reading My Personal Prostate Cancer Treatment Options