Cases - Business

As a human resources specialist for many years, I've seen it all when it comes to job applications. Most disheartening were those applications in which applicants had not addressed the specified selection criteria ... they went straight into the 'no' pile. In many cases, it was obvious from

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

accompanying documents like the cover letter and resume, that the applicants were intelligent, experienced people who may have been good hires. However, as they hadn't addressed the selection criteria, they had disqualified themselves from further processing. In fact, an applicant has only t

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

miss one selection criterion to be disqualified from a recruitment process.

When an application arrived well before the vacancy closing date and it was clear that it didn't address the selection criteria, I would always write to the applicants asking them to rewrite their applications and

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

esubmit. I attached a short brochure advising them how to go about it. Some resubmitted, most didn't.

Why Have Selection Criteria?

All job selection techniques ultimately follow the same premise: that if you did something well previously for an employer, you will most likely be able

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

to do it again for another employer. Organisations that use selection criteria use them to focus the knowledge, skills and attitudes applicants posess, to those required to successfully carry out a job. Take for example, a selection criterion, 'Demonstrated ability to use the Microsoft Offic

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

suite of software programs'. Applicants would demonstrate such ability either by giving details of a course of study they had completed that covered all MS Office programs or describing where and when they had used the programs and what they did (or a combination of both). If they ha

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

d used only a few of the MS Office programs, then perhaps they wouldn't meet the criterion.

The Challenges of Responding to Selection Criteria

The criterion above is nebulous because it doesn't say to what extent you have to 'use' the software. Does it mean you've loaded it a few ti

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

es and created a small spreadsheet, document, project outline, email, or slide show? Or does it mean that you must have mastered each program at an advanced level? In trying to create a criterion that is objective, the writer has in fact created subjectivity ie, the degree to which use is ex

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ected/required.

This highlights the first challenge of selection criteria; determining what the writer intended. Unfortunately, not all criteria writers are good at English expression. The solution is to try to 'over qualify' the selection criterion. In the above example, what you would do

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

s provide examples of the type of use to which you put MS Office programs, which programs they were, and what the outcome was eg, 'I produced a spreadsheet to calculate break-even point which used seven different formulae including sum, average,' etc. Does this make sense?

If other applican

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

s simply state that they use MS Office, your response has to be better because the degree of use is evident. An applicant showing a higher degree of use should beat an applicant showing a lesser degree of use, but it doesn't say that in the criterion.

Another challenge is actually meeting s

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

election criteria. Say the above example said, 'Demonstrated ability to use the MS Office Suite of software programs in an accounting office. What difference do you think that would make? Heaps. It would automatically disqualify any applicant who hadn't used the software in an account

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ng office. (But that's not a good reason to chuck in the towel).

When you analyse selection criteria you need to know that you can not only meet all criteria, but each element within every criterion. If you miss one element within any criterion or all the elements of any criteria, you're in

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

trouble. This means that you must carefully analyse every criterion to determine how many elements it contains and respond to each element. In our previous example, we know that MS Office Suite consists of MS Word, MS Excel, MS Outlook, MS Powerpoint etc. If you miss one of those programs, y

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

u haven't met the criterion.

Knowing when to stop writing is a good thing. Once you have written sufficient to meet the criterion, you need to stop. Giving 23 examples of how you used MS Office is superfluous and will drive the assessor nuts.

Try to intuit (guess) what criteria really want

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

you to do and frame your answer accordingly. For example, if you were answering the above criterion for a reception job at an accounting firm, ask yourself what types of things you'd be doing. I would expect a receptionist to perhaps use email a lot, produce letters, maybe run an address boo

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

k or appointments calendars. In your reply highlight the topics you feel are most related to the job. But don't lose sight of the other elements either ... remember you must address all of the criterion.

Responding to the Challenges

You can improve your responses by studying some of

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

the written materials available that address selection criteria. Discover the secrets for yourself and practise improving your responses every time you apply. Ask those who are successful job applicants if you can read their response to see if there is anything you can learn from it. Find so

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

eone in your group of friends or colleagues who you know is excellent with the written language and ask him or her to help you by proofreading your applications.

At the end of the day, writing selection criteria isn't rocket science. Like anything else, you can learn how to do it and master

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

the art within a fairly short time. If you are spending time writing job applications addressing selection criteria and aren't getting interviews, you need to ask whether you are doing the best job possible. If not, make a conscious effort to get your act together.

Copyright Robin Henry 200

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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