Preventing Chaos: The Critical Role of the Submission Lead

Pharmaceutical product marketing applications represent the end result of years of development, significant financial investment, months of work, and the collaboration of a very large cross-functional team. Clearly, the Submission Lead for any marketing application team is a critical role. Experienced regulatory/medical writers often have the necessary array of skills to make excellent Submission Leads, whether they are overseeing only the writing activities or leading the entire submission team. The Submission Lead serves as the “connector” by providing strategic and tactical oversight throughout the process to ensure on-time preparation of high-quality documents. By enabling the work in each stage of the submission, from initial regulatory submission strategy through publishing and submission, the Submission Lead ensures the development of a comprehensive and cohesive marketing application. Submission Leads wear many hats and ensure that the team is functioning well and communicating at all times. Teams benefit from a Submission Lead with extensive marketing application experience because they are better able to mitigate the challenges and risks that arise. Submission Leads fluent in the strategy and content of the submission are able to drive discussions and prioritize team activities. Most importantly, as the project progresses, this strategy and content knowledge allows the Submission Lead to recognize potential cross functional impacts of each new development and to ensure the necessary parties are brought together to address those impacts. Like any large team effort, a clearly defined lead role and agreed processes are critical to achieve a high-quality, on-time marketing application that is accepted for review and ultimately results in regulatory approval.