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The federal resume is one of three documents required for official applications for jobs within the federal government. The other two are the OF-612 and the

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

traditional SF-171 – and it’s hard sometimes to figure out which agency wants what document, because some offices prefer one over the other So your best bet i

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

Examples of combination products may in

s to submit a federal resume – it’s considered the most current type of resume for government employment and, even if the department in question would prefer

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

a different style, you’ll still look like you know what you’re doing!

A federal resume should be developed in the “chronological” resume format, listing your

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

work history in reverse order of when you were employed. It must also include some additional information that’s not usually requested by civilian employers.

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

Combination pro

You’ll need to include:

Job Information (job/listing number, title, series and grade of job)

Personal Information (full name and address, day and evening p

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

hone numbers, social security number, country of citizenship, veteran’s preference, reinstatement eligibility, highest federal civilian grade held)

Education

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

(high school, including name, city, and state, date of diploma or GED, colleges or universities, including name, city and state, majors, type and year of any

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

degrees received)

Work Experience (job title, duties and accomplishments, employer’s name and address, supervisor’s name and phone number, starting and endi

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

ng dates, hours per week, salary, references)

Additional Qualifications (job-related training courses, skills, certificates and licenses, honors, awards and

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

special accomplishments; for example, publications, memberships in professional or honor societies, leadership activities, public speaking and performance awa

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

Following aspects would a

rds)

It may seem odd to provide so much information before you even get an interview, but keep in mind that applying for government jobs is very different th

dd to the challenges in developing combination products:

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

an applying for private ones. The purpose of the federal resume in the private sector is to get an interview, after which an employer will ask for more inform

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

ation. In the government, the purpose of the resume is to present your qualifications, proving that you meet eligibility requirements, so that you can be appr

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

oved by the Human Resources office. Your federal resume, therefore, needs to include similar language to that in the job announcement, because the HR speciali

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

st will be looking for applicants with experience that meets the requirements of the open position.

Your federal resume should cover about ten years of emplo

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

Professional from academic institutions, pharmaceutical industries, health care indust

yment, with details describing your accomplishments. Focus on highlighting skills that are compatible with the the position for which you are applying. The re

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

sume should be no more than three to five pages long, plus pages outlining your knowledge, skills and, where applicable, performance ratings. Start with three

.

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

pages as a goal. If you don’t have the work experiences to fill three pages, that’s okay – just make your on to two pages the best they can be.

If you ar

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

Companies that provide selfless information through particip

e looking for additional information on federal resumes, KSA and ECQ documents, and Resumix applications, check the other articles we have published here.

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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Navigating the process of gathering business requirements and creating the business requirements can be hard enough without adding the issue of stakeholder management to the equation.

Most of us have known a few LOSERS in our career. Problems surface and we face challenges. Who are the ones we call losers? Where did they come from? How did we end up with them on our payroll? Who hired them?

Can we franchise the world and keep the greed and corruption away, by taking out the human factor? Many people agree that the United Nations is not solving the differences of the human species in the present period and that something must be done to prevent a repeat in history like after the collapse of the League of Nations.

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