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Hetal Shah

Hetal Shah

Independent Medical Writing Consultant

Title: Project management in medical writing

Biography

Biography: Hetal Shah

Abstract

Medical writing has now evolved from being a sub-specialty service to a full-fledged line of business in the Healthcare Industry. A lucrative career option in itself, medical writing offers avenues not only as individual contributors, but also leadership and managerial positions. While, typically, medical writers develop documents individually or as a team, it would be worth extrapolating and comparing medical writing as an operation and treating each assignment as a project. With this, principles of project management usually applied to operational scenario can also be implemented to Medical writing profile and projects to further ease out and systematize the medical writing as a function. In medical writing, it is estimated that while 60% of a writer’s job is actually writing, 40% is project management. Hence, besides being technically equipped to execute the core activity i.e. draft the required document, project management skills are also desired in a medical writer. Project management is the application of knowledge, skills and techniques to execute projects effectively and efficiently. The concept of project management revolves around balancing The Triple constraints – Time, Scope, Cost; keeping Quality as the core. The discipline of project management is about providing the tools and techniques that enable the project team to organize their work to meet these constraints. Project management processes falls into five categories – Initiation, Planning & Design, Executing, Monitoring and Controlling, and Close-out. This presentation shall describe the extrapolation of project management concepts to Medical Writing as a function, and involve discussion on each aspect of project lifecycle in lines of a medical writing project, and a step-wise schedule of events/activities for handling a medical writing assignment from initiation to close.