The quality of leadership within the organization is critical from a business perspective. Yet, according to Gallup’s research, the majority of leaders are not equipped to take on the leadership roles. This status quo hurts not only employees but also decrease the performance of the organizations. Much could be achieved by providing relevant training and development opportunities to the managers and leaders. Many companies though do not invest in leaders’ training and poor management comes at the expense of U.S. economy, costing $398 billion annually. Continue reading
Inspection Readiness (IR) is a proactive process. It is a process of ‘getting ready’ for an inspection by a regulatory authority (such as FDA), which is conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial. 
Every drug development program is led by some type of the team leader. Such position may have different names in every organization (e.g. asset, team, program, project lead, etc.). The primary accountability of that individual in all pharma organizations is yet similar: to deliver the program to support the R&D strategic goals and direction. 
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