The Importance of Writing to One’s Career
The famous Renaissance author, courtier, and father of deductive reasoning, Sir Francis Bacon, once said, “Reading maketh a full man, conference a ready man, and writing an exact man.” Sir Bacon could not have been any more correct, especially when speaking of writing. Even in today’s society filled with computers and a wide range of other technology, the written word is still held with great importance, primarily in the business world. Most careers require writing of one form or another for a variety of reasons. Clinical Research Management, my intended career, is not an exception. Clinical Research Managers (or CRMs) must have an in-depth knowledge and understanding of Federal and local regulations guiding research, the procedures involved in the development of new drugs and medical equipment, research protocol development, institutional review board requirements, and business and budgetary aspects of clinical research trials. CRMs are on the cutting edge of research designed to improve health and illness outcomes across the continuum of care. They also have the opportunity and the responsibility to educate colleagues and research participants on the multifaceted issues surrounding the conduct of clinical researc
Writing is key to the data editing process because it is the job of the CRM to analyze the data accordingly so that the rest of the pharmaceutical company, such as the CEOs and marketing personnel, can understand it. These analyses are written out in the forms of company newsletters and e-mails. This way, other employees are aware of the drug’s purpose and the progress that is being made throughout its development. The CRM often receives questions and comments about the drug where a response is necessary in the form of an explanatory, informal letter or e-mail. The Clinical Research Manager must have a firm grasp on advanced writing skills for this task because they must be persuasive enough to convince not only the company CEO to approve the drug but the FDA as well. Although the final report is reviewed by editors before being sent off to the FDA, it is the words and ideas of the CRM that form the backbone of the report. Their purpose is to convey the basic and pertinent principles of the drug in writing to many others. Ultimately, their writing is the link between the drug and the people. Written clinical trial documents and reports are also important pieces to the job of a Clinical Research Manager. Clinical documents are written by CRMs which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. The various documents are grouped in three sections according to the stage of the trial during which they will normally be generated: 1) before the clinical p
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Approximate Word count = 1036
Approximate Pages = 4 (250 words per page double spaced)
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