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    As a consultant, you meet all types of executives in business -- the good, the bad, and the ugly. Driven by big egos, big jobs, and big money, some C-level honchos can be tough cookies.

    Even though the vast majority of them are smart, savvy, intuitive, charming, talented, persuasive, and colorful, there are a few enfants terribles who have elevated bad business practices and behavioral eccentricities to an art form. These “execs gone wild” can severely strain business relationships and make your life profoundly difficult.

    Consultants are often brought on board to solve a problem in times of rapid growth and impending crisis. While their ostensible goal is to confirm the client’s problem, suggest a path or a process to tackle it, and implement a solution that will produce tangible, measurable, and desired results, their real objective is to make sure their clients don’t impede or undermine their efforts.

    Corporate Archetypes

    This paper profiles the types of clients who create irritating potholes
    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
    and fissures on the road to business success and reveals the behavioral patterns that characterize their so-called “worst practices.”

    These archetypes are drawn from behaviors all too common in the business world. The most difficult executives are an amalgam of these archetypes and share several commonalities: distrustful, controlling, aggressive, inflexible, paranoid, and occasionally tyrannical. It is facile to suggest that these behaviors are always intentional or driven by a sense of malice. Rather, it is fear, ignorance, insecurity, and thoughtlessness that are at the root of the most egregious worst practices.

    The Bureaucrat

    Native habitat: Large, mature company

    Status: Middle and upper management

    Modus operandi: To preserve the status quo; protect one’s turf and job

    Traits: Myopic; slow-moving; risk-averse

    Bureaucrats are easy to spot. They seek shelter with the herd and are rarely found in one-to-one settings. However, don’t underestimate their ability to
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    throw a monkey wrench into your project and sabotage your best-laid plans. They have a penchant for making eleventh hour changes and questioning the earlier decisions of others.

    Recommendations: Since procedure means the world to these individuals, avoid confrontation and play into their strengths. Ask them to explain the rules. Get everything in writing, including sign-offs. Acknowledge their status while establishing mutual expectations. You’ll find that you can work with them as long as you don’t violate any deeply-cherished institutional edicts.

    The Autocrat

    Native habitat: Small to mid-sized company

    Status: CEO, COO

    Modus operandi: To exercise control; interfere; intimidate others

    Traits: Imperious; egotistical; aggressive; capricious

    Autocrats rule by whim. They flourish in a relatively flat organization and find it difficult to delegate to subordinates. Autocrats will subvert the rules in order to assert authority and control, and are convinced of their ow
    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 self-importance and infallibility. Autocrats use intimidation to keep you off balance (e.g., calling before and/or after business hours, making unilateral changes to written agreements, changing strategy without warning, etc.).

    Recommendations: The best way to handle Autocrats is to stay calm, hold your ground, and negotiate new ground rules. Warning: Autocrats won’t change their ethics overnight. At a certain point, you simply may have to walk away.

    The Know-It-All

    Native habitat: Any size company

    Status: All levels

    Modus operandi: To show superiority; be right; maintain control

    Traits: Impatient; arrogant; inflexible; micro-managerial

    Know-It-Alls “know” what’s good for their business and can’t wait to demonstrate their capabilities to you. They’ll challenge your ideas, devalue your work, and sometimes even do your job for you. No matter what you accomplish for the Know-It-All, it’s never good enough.

    Recommendations: Build a contingency into your contract to
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ensure you will be paid for any work beyond the scope of the agreement. Know-It-Alls perceive outside expertise as a threat. Be that as it may, they really do need help. Since Know-it-Alls have the final word, strive for agreement every step of the way, and be sure to present alternate concepts and approaches. They may like what you show them, but, ego aside, it was their idea from the start.

    The Waffler

    Native habitat: Large company

    Status: Middle and upper management

    Modus operandi: To avoid conflict and making mistakes; protect one’s job

    Traits: Indecisive; distrustful; insecure

    Easily the consultant’s worst enemy, Wafflers can be a major roadblock. Despite their position, they are not born decision makers. Within their own company, they are often lauded as a team players and consensus builders; however, for consultants, they represent delay, doubt, and indecision. Wafflers will not go out on a limb for you. They won’t even go out on a limb for themselves. This
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    can seriously affect the progress of your work and the success of your project. Wafflers have a difficult time committing to anyone or anything, especially if it means making a bold decision for which they’ll be held accountable.

    Recommendations: Wafflers needs reassurance and a lot of hand-holding. Give them a milestone chart and deadline reminders, and reemphasize the objectives of the project. If roadblocks still persist, move up the value chain and seek alignment with more responsive and committed contacts within the client company.

    The Tight Lip

    Native habitat: Small, private company; start-up

    Status: C-Level; Upper management

    Modus operandi: To hide and protect company secrets; keep you at arm’s length

    Traits: Guarded; uncommunicative; aloof; cryptic

    Signing an NDA with a client doesn’t mean you’ll be told everything you need to know to do your job well. Tight Lips are notorious for not communicating the essentials—business trip schedules, company plans, val
    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
    uable feedback, etc. This situation is exacerbated when their native language is different from your own or when their communications abilities are minimal at best. When Tight Lips are paranoid about their company’s supposed intelligence, you’re going to find yourself out of the loop. A high degree of confidence is required before a new consultant can be entrusted with privileged information. Until such time, expect to be informed on a “need to know” basis and greeted with a veil of secrecy surrounding most company decisions and transactions.

    Recommendations: There is no simple solution here. Probe, ask questions, throw out a few assumptions to see whether they stick to the wall, and hold the Tight Lip to account when important details are glossed over. If you’ve crossed over an imaginary line, you’ll know it.

    The Hand Wringer

    Native habitat: Large and mid-sized company

    Status: Middle management; project management

    Modus operandi: To avoid trouble and being judged; protect sta
    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
    tus quo

    Traits: Skeptical; pessimistic; anxious

    Hand Wringers predict catastrophe wherever they go. They see the glass as half empty and are shocked when things go right (a deviation from the norm). They trust no one, have little or no confidence in themselves, and tend to second guess their own judgments. Like many other archetypes, Hand Wringers are high-maintenance and need a lot of reassurance. If you’re the impatient sort, you may not enjoy the constant phone calls, questions, whining, and complaints.

    Recommendations: Stay positive, communicate clearly, and focus on achieving realistic goals. Break the project down into bite-sized chunks that are palatable and digestible. Sure, it’s nice to be a tower of strength and a beacon of understanding, but, remember, you’re not a panacea for the Hand Wringer’s anxieties. In order to deflect negativity and incessant worrying, you need to remain impassive and firm in your beliefs and expectations.

    The Absentee

    Native habitat: Small co
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    pany; start-up

    Status: CEO/Managing Director/Owner

    Modus operandi: To be busy and in control

    Traits: Detached; self-absorbed; unfocused

    Nothing is more frustrating than having a client who doesn’t give you straight answers, won’t return phone calls, and is constantly inaccessible and unreachable. Absentees are elusive control freaks who wield their authority from afar where you can’t get a handle on it. But, then again, maybe you can. After all, you’re the one controlling the work, especially its outcome.

    Recommendations: Don’t use e-mail to communicate with Absentees. Instead, leave very brief and matter-of-fact messages on their personal cell phones (try to get the number). Talk about consequences with a sense of urgency that they can understand, e.g., the impact on their bottom line, their company’s credibility, and the market opportunities they’re missing. Whatever you do, don’t get bogged down in minutia. Eventually, Absentees will resurface or come down from the m
    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
    ount. When they do, be prepared to move with speed, determination, and an unflagging sense of confidence in your ability to get things done.

    The Perfectionist

    Native habitat: Small and mid-sized companies

    Status: Upper and middle management

    Modus operandi: To be secure and right; maintain order; preserve status quo

    Traits: Self-critical; fearful; obsessive

    Some people can live in chaos and confusion. This isn’t the case with the Perfectionist. Perfectionism, however, is only a symptom of a deeper disorder – a desire to control people and events coupled with a fear of change. Without getting too deep into psycho-babble, let’s talk about this in practical terms. Your job is to manage the project and, as evidenced in this paper, manage the client. Perfectionists typically like to be assured that everything is proceeding on course according to their expectations.

    Recommendations: Keep Perfectionists in the loop and in control by meeting with them in person. It is extr
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    emely difficult to manage this relationship by phone. Let them throw in their two cents and make the operationally mundane decisions governing your project. Acknowledge their need to tweak, fiddle, and keep order. However, give them forced choices so they can choose the best option. If you keep things too open-ended, they’ll never be secure in their decisions.

    The Exploiter

    Native habitat: Small and mid-sized companies

    Status: Upper and middle management

    Modus operandi: To extract blood from a turnip

    Traits: Demanding; conniving; manipulative

    Industrious, prodigious, and hard-working consultants beware: At some point, your client will take advantage of you and your goodwill. Assuming that you have an agreement which spells out your work and fees in detail, Exploiters will still try to get more out of you. They’ll leverage whatever they can -- your friendship, your expertise, and your good nature – and do it with a smile. That makes it really difficult to say “no.”
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    If you cave in too often, though, you’re in danger of becoming an indentured servant.

    Recommendations: Remember, the Exploiter will keep pushing until you push back. When you do push back, keep an eye towards compromise. There are a few favors or freebies you can throw in that won’t eat up your time, but will satisfy the Exploiter’s need to extract more while the day is young and you’re still under contract.

    The Emotive

    Native habitat: Large and mid-sized companies

    Status: Middle management

    Modus operandi: To elicit sympathy; manipulate feelings

    Traits: Sensitive; impulsive; dramatic

    If you think the Hand Wringer is tough to manage, the Emotive will try to push all of your buttons at the same time. This is a person who really believes that high drama will lead to greater understanding and stronger business relationships. These histrionics may work with friends, family, and a few colleagues, but not with a steely-eyed consultant like you. Still, be on guard. Emotiv
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    s are looking for a crutch – a person who will listen, intervene on their behalf, and share their pain.

    Recommendations: Don’t get involved in company politics or the personal problems of your clients. Keep your wits about you, stay above the fray, and remain a neutral party. Sympathy is fine, but empathy crosses the line. Keep the relationship on a professional plane and refrain from responding to emotionally-laden appeals or outbursts. As long as you’re the paragon of cool judgment and impartial observation, your status as a consultant will not be compromised.

    Lessons Learned: The 10 Consultant Commandments

    Everybody needs rules, principles, or commandments to guide them in business. These principles don’t have to be written in stone, but they should form the backdrop of your decision making. Below are ten rules to minimize, if not neutralize, the effects wrought by difficult executives.

    Get it in writing.

    Most agreements don’t need to be long, legal instruments; however, they should contai
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    n caveats to protect your interests and compensation. Spell out the scope of the work and cover yourself for any additional work requested. If you have out-of-pocket expenses and want reimbursement, then mention it. If you have specific billing and payment terms, be as unambiguous as possible in describing them. In the event that your contract gets terminated, it’s important to have a cancellation clause to make sure you’re paid for work completed to date. If any disputes arise, then consider adding a clause that spells out how any disputes might be arbitrated. Avoid lawyers at all costs. This is all common sense, but it bears repeating: Get the agreement signed and dated, keep the hard copy, and remember where you file it.

    Get paid in advance.

    Cash flow is everything. If a project is 45 days long and your payment terms are net 30, that’s a month and a half before you see any money. Don’t get behind the eight ball. If you have recurring work, make sure you get a retainer paid at the beginning of
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    each month. If you’re engaged on a project basis, then ask for one-half or one-third in advance. You can also seek additional protection by sending a progress bill if the project is delayed beyond its initially expected duration.

    Set expectations.

    The understanding you reach with your client at the very beginning of an engagement is critical to ensuring its success. Since many of the mutual expectations that you discuss initially will not be found in a written agreement, put them in an e-mail or a statement of work. Explain your process, define your deliverables, and describe the kind of resources and support you’ll need from your client. Be sure to gauge the level of urgency and buy-in. Find out who the decision makers are and who will be reviewing your work. Get to know the Accounts Payable person and others who could serve as valuable allies. Walk in with both eyes open, and you’ll be prepared for any unpleasant surprises.

    Don’t give away the store.

    To maintain a viable consultancy, you need
    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
    to know one thing – what you’re worth to the client in dollars and “sense.” Although your value to the open marketplace may be considerable, an individual client may think otherwise. Whatever you charge, you need to feel comfortable with it and have a minimum threshold you’re willing to accept. Don’t ever sell yourself short. By the same token, never tell the client everything you know. Sure, you may be able to solve multiple problems in one fell swoop; however, if it’s beyond the scope of the agreement, keep mum and show some restraint. You don’t want to blow your wad and lose out on future engagements. In other words, don’t give away the store. Knowledge is golden. Hold some of it back for your own sake.

    Keep selling.

    You’ve honed your craft. You’re competent at what you do. That doesn’t mean your client perceives your true value. Just because you got the consulting gig doesn’t mean you’ll be around in a few months. To ensure your desirability, keep selling. That means demonstrate your value w
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    enever possible and show your client the depth of your understanding and resourcefulness. Sometimes that will require reinventing yourself and your offerings from time to time. Tell your clients something new and don’t let your pitch get rusty.

    Seek win-win situations.

    You’ve heard this all before, but it’s a lot easier said than done. Every engagement into which you enter is a negotiation. You need to get what you want (terms, schedule, payment, etc.) as does your client. Since things never go as planned, misunderstandings are likely to develop and you may be asked to accelerate the work schedule, perform extra duties, or redo portions of your work. In other words, you need to be flexible. Keep in mind, though, that you’re an equal partner in the win–win equation. It’s advisable to meet the client a little more than halfway, but never all the way. Remember the wisdom of the following forced choice: good, fast, or cheap. Tell your clients they can pick only two of them.

    Maintain your distance.

    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    It is said that familiarity breeds contempt. This is no less true when it comes to consulting. To avoid smelling like a dead fish, keep cordial and maintain a proper distance. If you don’t need to be on the premises, get out of Dodge. You don’t want to be treated like an employee but, rather, the highly-talented, objective consultant that you are. Just like the Western hero whose special skills are required to fix a problem the townsfolk can’t solve, you’re a hired gun who engenders feelings of trust and admiration. You’re paid to do a job. Keep the client happy, dazzle them with your expertise, and then leave town. However, since clients have a short memory, be sure to stay in touch down the line.

    Cultivate a sense of humor.

    A good sense of humor and the perspective that comes with being an objective outsider can really grease the skids in a business relationship. After all, it’s just a job and you’re not buying the place. Use humor to diffuse a situation, put clients at ease, and demonstrate th
    .

    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
    at you take your responsibilities, not yourself, seriously. Consultants should act more like ice cream vendors. Every client has a sweet tooth. Your job is to touch a nerve, increase receptivity, and leave them smiling.

    Take the high road.

    Clients can act atrociously if they want, but you’re the consummate professional. Even though it’s tempting, put down the mud patty and try to live up to the highest of standards. Let them rant and rave. They’re entitled to their opinion. But at least they can never say you’ve been unethical or unprofessional.

    Know when to walk away.

    Sometimes damage to the business relationship is irreparable...and it’s not just a question of stubbornness. Not everyone is reasonable – or even rational for that matter. When all else has failed, it’s better to cut your losses and call it quits. Deselect and decompress. Make it sound like a mutual decision (i.e., "it’s better for the both of us" or "you need a different kind of agency or consultant"). Wish your client the best
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    of luck and then move on.

    Summary

    Good consulting starts and ends with clear and open communications. A successful consultant is part salesperson, part psychologist, and part gunslinger. Managing the project and excelling at the work is only a small part of the equation. Understanding the vagaries of human nature and the fragility of the human ego are just as important. That includes “knowing thyself,” too. After all, you’re just as human as the next person.

    Consulting is all about building and sustaining business relationships, the cornerstone of which is a healthy dose of common courtesy and mutual respect. Real people are more than the sum of their behaviors or the instructions on their archetypal labels. However, when you do run across the above mentioned eccentricities, see them for what they are (ugly little distractions), try to invalidate them with just the right word, gesture, or consulting agreement, and get on with the business at hand.

    © 2007 Eric Stephen Swartz. All rights reserved


    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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