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    You've recently been promoted to management, and are now responsible for the department in which you were previously employed. One of your former peers had also applied for the job, and you are now feeling waves of resentment from him th
    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
    at threaten the success of your promotion.

    Does this sound familiar? If so, you're certainly not alone because it's one of the most common challenges faced by new managers. Here are some ideas to help you deal with the situation.

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

    Examples of combination products may in
    nitiate a discussion

    It's imperative that you sit down and have a meaningful discussion with the individual concerned. Your two objectives are to find out specifically how he or she is feeling, and from there to figure out how you c
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    n enlist their co-operation and help them become a productive part of the department that is now yours to run.

    Try to understand how they feel and why they are resentful

    The most obvious reason is that she really felt she was the
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    est person for the job. She has ideas on running the department and had been looking forward to putting them into action. Now she feels she has lost that chance.

    A lesser known, but possibly even more important, reason is loss of pride.
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    He may have told his nearest and dearest that he was in line for promotion, so now that he didn't get it, he is embarrassed. He feels he will be less in the eyes of his family or friends. So even though he may not actually mind the job
    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
    he currently has, you're facing some deep personal feelings he may have difficulty changing.

    The only way you'll find out is to ask questions, and then listen to the answers. Begin by saying you know the person was a candidate for the j
    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
    b, and that you also understand they were considered qualified. Then begin with a straightforward question such as, "Do you still feel disappointed and resentful?" Wait for the answer. If it's a curt "yes", probe for more. "Is that so
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ething you feel you can work around, or that will eventually settle down?" Or "How can I help you deal with that?" Keep probing until the person begins to talk.

    If she takes the opportunity to vent her feelings of anger, listen calmly f
    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
    r a bit, using body language to indicate you understand. Then step in to redirect the conversation so that it becomes productive by saying something like, "I understand you've been angry. However, I know you well enough to believe you
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    an get past it and honor yourself by doing the job you are capable of. Let's talk about where we go from here."

    Help them regain lost pride

    Before the conversation even begins, give some thought to what you know about the pers
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    n and how they work. How can you use their strengths to the benefit of the department? One effective way is to initiate a special project with a specific objective she can relate to, and put her in charge of it. It's important that this
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ot be an unimportant "make work" project, but rather something of value. You might even come up with it in discussion with the employee, which gives it the benefit of her buy-in.

    This kills two birds with one stone: completion of the
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    roject benefits the work of the department, and putting the person in charge provides an opportunity to shine. This helps them regain any self-confidence that may have slipped, and they have a "win" to report to those who care about th
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    m. It's also a positive achievement that can count towards possible future promotion opportunities.

    What if it doesn't work?

    If you give people consideration through this process and then give them every opportunity to come on b
    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
    ard with you, and they still won't co-operate, then stronger measures are called for. In this case you must have another discussion.

    This time you frankly point out their ongoing shortcomings and how they are creating a toxic environmen
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    that adversely affects the whole department and its work. Candidly tell them that if they can't find the inner strength to change their attitude and make a productive contribution, then there is no place for them in your department. F
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    om then on, follow the usual process when someone is "on probation", monitor their progress and act accordingly. As the common management consulting expression goes, "If you can't change the people, you have to change the people!"

    In
    .

    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
    recent interview with Management Consultant Mike McInerney, he told me this situation arises at all levels. Young managers may be surprised to learn that even Presidents have to deal with the resentment of unsuccessful candidates. The
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    difference, according to McInerney, is that those people have learned to deal with it, and they don't let personal feelings stand in their way. If you are new to the world of management, you'll do well to take your cue from their example


    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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