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    There has been a lot of politically correct pontificating of late in corporate circles about the differences between managers and leaders. Most of the commentary I have read attempts to please both audiences. Those of you who have read my work in the past know that I am rarely politically correct
    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
    nor do I ever seek to try and please all the people all the time.

    While there is clearly a need for both managers and leaders in the business world and while I respect and have developed close friendships with many a manager, this author simply believes that the law of scarcity applies to the 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
    opic at hand. There is an infinitely greater supply of managers causing a much greater demand for leaders. Put simply, because leaders are much more difficult to come by, they are therefore more valuable to an enterprise.

    The paragraph above begs the question why are there fewer leaders than man
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    agers? I believe it is because not everyone has it in them to be a leader and thus the old axiom “a born leader”. The intrinsic quality of leadership often begins with nothing more than raw talent and a certain state of mind. To possess the innate qualities of a leader is however not the same thi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    g as being a leader. As important as your DNA is, effective leadership skills are developed and refined by time, experience, and a true desire to be more than just a manager, but a true leader.

    Let’s breakdown the DNA of a typical leader…A leader is usually a very creative, dynamic, outgoing and
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    unflappable individual. They tend to think big picture focusing on vision and strategy while looking to make a long-term impact. By way of contrast let’s examine the DNA of a manager. Managers are usually more analytical while focusing on process and procedure looking to make short-term contribu
    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
    tions. The following list adapted from Mind of a Manager, Soul of a Leader by Craig Hickman, John Wiley & Sons, demonstrates the DNA gap between leaders and managers:

    Managers build systems and procedures, Leaders build teams and develop talent.

    Managers surround themselves with subordinates &
    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
    eaders surround themselves with the best & brightest.

    Managers avoid risk and Leaders thrive on risk.

    Managers find comfort in the status quo & Leaders serve as a catalyst for change & growth.

    Managers settle for industry standard & Leaders demand the best.

    Managers wield power while Leaders
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    apply influence.

    Managers control & Leaders inspire.

    Managers formulate policy & Leaders set examples.

    Managers instruct...Leaders mentor.

    Managers are reactive while Leaders are proactive.

    Managers plan...Leaders innovate.

    Managers refine...Leaders revolutionize.

    Managers reorganize...Lea
    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
    ders reinvent.

    Managers pursue the tangible while Leaders seek the intangible.

    We have all witnessed companies that have been over managed in the absence of leadership. When leadership has been abdicated to management in a corporate setting you will always find that growth slows, morale decline
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    , creativity wanes and the competitive edge is weakened. That being said, I have personally experienced the value of true leadership at every stage of my life from the athletic playing field, to the military battleground to the corporate boardroom. Let’s look at an example of the value of leaders
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    hip from each of the three areas:

    • An example from the world of athletics…If you were the owner of an NFL franchise and had to choose between having the #1 quarterback in the league or the #1 center in league what would your choice be? Again this doesn’t mean that a great center isn’t valuable,
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    it just means that the role player isn’t as valuable to the team as having the talent factor and leadership characteristics of a true impact player. Simply reflect back upon your own life experiences and you’ll see that you have come across many utility players over the years, but very few franc
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    hise players.

    • A military example…Contrast if you will the differences of two enlisted men of the same rank. The fist is a sergeant in a headquarters unit charged with the administrative support of a company commander. The second sergeant is a combat controller in a special operations unit char
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ed with coordinating air strikes from the ground behind enemy lines. While both of the enlisted men described above hold the same rank, are part of a team, and play important roles, one is clearly an impact player in a leadership capacity while the other is solely a utility player acting in a man
    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
    agement capacity. The military has determined that it is a rare individual who exhibits the characteristics necessary to become a member of a special operations unit. Therefore they are willing to make a much larger investment in the combat controller and in return the military expects a much lar
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ger contribution from that individual.

    • A corporate example…This example will be short and sweat, but hopefully very clear in its statement of impact. Who do you believe is of greater value and makes a larger contribution to a corporation, someone who administers policy and creates processes or
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    someone who sets the vision and creates the strategy? Just examine the difference in the pay stubs of the two individuals contrasted above and you’ll quickly see who the enterprise deems to be of higher value.

    I want to be clear that I am not “anti” manager. I am however very “pro” leadership wh
    .

    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
    en it comes to optimizing the talent factor in any organization. My bias toward leadership doesn’t mean that I don’t understand the principles behind such truisms as: “there is no “I” in team” or, “the sum of the parts is greater than the whole” or that “a chain is only as strong as its weakest l
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ink.” Rather it simply means that I believe you achieve a much greater return on human capital with investments made into leadership due to the scope and scale of the impact that a leader can make. The bottom line is that I prefer to lead rather than manage and to be led rather than to be managed


    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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