Project management is a discipline in companies that focuses on processes and their continued improvement, as well as achieving outcomes, for specific projects. Planning, program design, process design, communication, coordination, resource allocation, and timing of people, systems, information, and their projects comprise key elements of project management. Although the common goal across the company is developing a product, a company has many distinctly different departments all contributing to product development with very different projects and outcomes, different operations, different expectations, different education, and different cultures; however, they all need to be brought together to function as a unit. Efficiency in operations of R&D has repeatedly been identified by analysts of, and senior management at, pharmaceutical companies as an important means to reduce cost and improve productivity. Of course the drivers of this efficiency requirement are the very high cost of R&D, now $800 million up to $1 billion per new product; the longer development times and slowing product approval rates, especially for NMEs; and the complexity of R&D. R&D can be very amenable to various efficiency improvements as follows. Many work items are done for an IND and NDA for a product by many separate departments by a large number of people with varied amount and levels of experience. In addition, the processes and outcomes (studies, reports, and applications) are highly structured and detailed. In the past, managers from research or clinical trial areas with technical expertise became the team leaders and coordinators of team projects. However, the role of coordination, tracking, and communication of a team of technical people requires an additional skill set and tools for these operational functions. This section of the chapter discusses the process of project management and a couple of roles that PM people can offer to an organization. A complete presentation of project management is found in book publications and is beyond the scope of this book.
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What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.