11
Oral and Written Skills
Another consideration in hiring an employee is the individual’s writing and speaking
skills. How well do they express themselves? Is the writing concise and clear? Which
authors do they emulate? Most experts agree that to learn to write well, you must write
often and read selectively, choosing material from respected authors. A writing style
can be improved by reading works by E.B. White, Tom Wolfe, William Safire or James
Kilpatrick. Much can be learned by reading the concluding chapter of The Elements of
Style, by William Strunk, Jr. and E.B. White. Lewis Thomas and Sherwin Nuland are two
highly acclaimed medical writers and their books or essays are worth reading over and
over again. William Zinsser, in his book, On Writing Well,8 describes the attributes: clarity,
brevity, simplicity and humanity. Other guides to the principles of clear writing are Style—
Toward Clarity and Grace9 and Why Not Say it Clearly?10 A regulatory professional should be
taught to learn from the masters.
FDA officials have lamented that submissions from industry lack organization, are
unclear and incomplete. On the other hand, a recent survey from biotechnology, phar-
maceutical and medical device firms noted FDA’s requests for data are often unclear as
well. In the survey, 30% of respondents observed that lack of clarity in the data requests
from FDA to life sciences companies has impeded or actually stopped the review process.
Perhaps it is time for both industry and government to review Fowler’s Modern English
Usage. In the 7 April 1969 issue of the Journal of the American Medical Association, Richard
Asher suggested writers take note of “The Elephant’s Child,” a Rudyard Kipling poem:
“I keep six honest serving men:
(They taught me all I knew)
Their names are What and Where and When
And How and Why and Who.”
These six serving men are used to attain most of our knowledge. Remembering who will
read your work and then how to make it plain, simple, accurate, orderly and complete are
the keys to a clear writing style.
Public Speaking
The ability to address an audience is another important characteristic of a regulatory
professional. Has the prospective employee ever been to Toastmasters or taken public
speaking courses? In this business, we are often called upon to extemporaneously describe
regulatory matters or to arrange and chair meetings with regulatory agencies. Having
confidence in our ability to speak at and properly organize such meetings can make the
difference between approval and disapproval of a submission. A handy guide to individu-
als who are unexpectedly asked about some work-related matter is the PREP method.
Speakers use this acronym to arrange their thoughts before uttering something disjointed
or out of context. The first P stands for point that is, the opinion you have regarding the
question. It is the attention-getter. The R is for the reason behind the point. It should be
based on experience or something familiar. The E is for an example that is relevant to the
audience. The final P is merely to repeat the initial point. There are also a number of books
to help make us better speakers, including Osgood on Speaking11 and I’d Rather Die than
Give a Speech.12 Keys to good speeches include being prepared, making it plain, being well
organized and practicing at length.
Understanding of Statistics
According to Peter Drucker, statistical thinking will one day become as necessary for
business as the ability to read and write. Thus, it would be extremely beneficial to find
Regulatory Requirements and Resources
Oral and Written Skills
Another consideration in hiring an employee is the individual’s writing and speaking
skills. How well do they express themselves? Is the writing concise and clear? Which
authors do they emulate? Most experts agree that to learn to write well, you must write
often and read selectively, choosing material from respected authors. A writing style
can be improved by reading works by E.B. White, Tom Wolfe, William Safire or James
Kilpatrick. Much can be learned by reading the concluding chapter of The Elements of
Style, by William Strunk, Jr. and E.B. White. Lewis Thomas and Sherwin Nuland are two
highly acclaimed medical writers and their books or essays are worth reading over and
over again. William Zinsser, in his book, On Writing Well,8 describes the attributes: clarity,
brevity, simplicity and humanity. Other guides to the principles of clear writing are Style—
Toward Clarity and Grace9 and Why Not Say it Clearly?10 A regulatory professional should be
taught to learn from the masters.
FDA officials have lamented that submissions from industry lack organization, are
unclear and incomplete. On the other hand, a recent survey from biotechnology, phar-
maceutical and medical device firms noted FDA’s requests for data are often unclear as
well. In the survey, 30% of respondents observed that lack of clarity in the data requests
from FDA to life sciences companies has impeded or actually stopped the review process.
Perhaps it is time for both industry and government to review Fowler’s Modern English
Usage. In the 7 April 1969 issue of the Journal of the American Medical Association, Richard
Asher suggested writers take note of “The Elephant’s Child,” a Rudyard Kipling poem:
“I keep six honest serving men:
(They taught me all I knew)
Their names are What and Where and When
And How and Why and Who.”
These six serving men are used to attain most of our knowledge. Remembering who will
read your work and then how to make it plain, simple, accurate, orderly and complete are
the keys to a clear writing style.
Public Speaking
The ability to address an audience is another important characteristic of a regulatory
professional. Has the prospective employee ever been to Toastmasters or taken public
speaking courses? In this business, we are often called upon to extemporaneously describe
regulatory matters or to arrange and chair meetings with regulatory agencies. Having
confidence in our ability to speak at and properly organize such meetings can make the
difference between approval and disapproval of a submission. A handy guide to individu-
als who are unexpectedly asked about some work-related matter is the PREP method.
Speakers use this acronym to arrange their thoughts before uttering something disjointed
or out of context. The first P stands for point that is, the opinion you have regarding the
question. It is the attention-getter. The R is for the reason behind the point. It should be
based on experience or something familiar. The E is for an example that is relevant to the
audience. The final P is merely to repeat the initial point. There are also a number of books
to help make us better speakers, including Osgood on Speaking11 and I’d Rather Die than
Give a Speech.12 Keys to good speeches include being prepared, making it plain, being well
organized and practicing at length.
Understanding of Statistics
According to Peter Drucker, statistical thinking will one day become as necessary for
business as the ability to read and write. Thus, it would be extremely beneficial to find
Regulatory Requirements and Resources