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    During times of change in an organization people tend to freeze and not want to take responsibility. As a change leader you need people who are empowered, yet many a leader just sits back and blames the people and become a dictator
    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
    extraordinaire. As a Marine sniper in Vietnam I saw leaders empower us young kids who knew nothing. One leader, Colonel Masterpool, had people that would follow him to hell and back just because of who he was and how he treated and
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ommunicated with us.

    When I worked for Frito Lay back in the late seventies and into and through the eighties, they came along and decided they’d ‘empower’ our mechanics that worked in the shops of our extensive private truck fleet
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    . They wanted to elevate them, they said, to positions of more responsibility. It was a big change in our modus operandi.

    Headquarters Human Resources were in charge of this charade and it became a program that was rolled out acros
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    the country. When it hit the streets it amounted to nothing more than a headcount reduction, we eliminated the vast majority of our Fleet Managers as they were called, the folks who ran the shops that maintained the vehicles of our
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    private fleet. It was called empowerment.

    When it hit the street it reminded me of the old quote from Alfred E. Newman, the one from Mad Magazine when he said, “Just because everything’s different doesn’t mean that anything’s chang
    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
    ed”. And nothing had changed except we were short several Fleet Managers and our all ready hard working mechanics were now disgruntled and severely over worked.

    The mechanics clearly understood day one that they would now do the wo
    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
    k of their former boss. They would now do all the paperwork, the parts ordering, the warranty claims, you name it. Of course the company rolled out systems to support this new work, right? No way. Come on you say, the company paid t
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    em, the mechanics, a little more money for the new work, right? Not on your life. They should be happy with their new responsibilities. One HR Manager actually said, “They should be happy we trust them with this work”.

    When you are
    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
    leading organizational change you cannot treat empowerment this way. The key to empowerment is having a clear vision that is communicated and people know what the end result looks like. Let me explain. People are surprised when I t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ll them in my thirty plus year management and leadership career I was most empowered as a United States Marine. That’s right, the Marine Corp, known for its discipline and my way or the highway attitude was most empowering. Let me t
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ll you the secret, why the Corp was so empowering.

    In the Marine Corp you are taught one single thing heading in to a mission … commanders intent. In a nutshell, commanders’ intent is the end game of the mission. Gentlemen, you are
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    to take that hill at coordinates 567123 by 0100 tomorrow morning. Now you make detailed plans and everyone has a particular role, not like the matrix management BS where leaders won’t make the hard calls. The plans are elaborate an
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    when the first shot is fired most of the plans go out the window, just like in your business. But if everyone knows ‘commanders intent’ it’s no problem, carry on and take the hill at 567123 by 0100 tomorrow.

    That is empowerment. I
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    each of our roles we were empowered to work together and deliver the objective. Did the plans change? Yes. Did we ad lib and do what we had to for the delivery of the objective, yes. Did we work together without arguing? No, but we
    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
    delivered the commanders intent because we all knew what it was and that delivering it and working together as a unit was, shall we say, a condition of employment. You must do the same in your change leadership or you will fail.

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

    Professional from academic institutions, pharmaceutical industries, health care indust
    powerment is a powerful feeling. It means you truly give me the power to deliver on my job. And understand it is a byproduct of solid leadership, not a program. How many leaders today do that? Darn few. Think about it. With the intr
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    duction of pagers and cell phones everyone wants a call. Twenty years ago when you left the office you had to leave people in charge because you couldn’t communicate with them. And they grew in the process. Today people are so vainl
    .

    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
    y important they have to be talking walking along in the airport. Give me a break. It is the same in times of organizational change too.

    Lead like you trust your troops. Lead by giving them solid direction in the beginning, communi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ate with them clearly and consistently along the way and they get out of the way … that is empowering leadership and that is what drives change. It’s not about the posters and slogans from HR, it’s about the leadership on the ground


    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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