AMWA Medical Writing Conference 2022

Modern regulatory submissions are often very complex; therefore, having a knowledgeable person with regulatory writing expertise to lead a cross-functional team through the regulatory submission process is becoming a necessity. In conjunction with the Regulatory Affairs Lead, a Regulatory Writing Submissions Lead (ie, Submission Lead) guides the team in development of a comprehensive eCTD content plan and the strategy to align document authoring, reviewing, and publishing activities to meet the targeted submission date. Submission Leads are also essential in developing a submission strategy along with the Regulatory Affairs Lead, ensuring consistency in messaging, and adherence to regulatory requirements. Early planning for multiple Health Authority submissions and best practices discussions are key tools for success. This session will explain the Submission Lead role, benefits the role brings to a team, and the developmental pathway to becoming a Submission Lead.

Patient-centricity is not just a topic for Clinical Science and Medical Affairs! As Patients and Patient Advocacy Groups (PAGs) become more connected, informed, and organized, how can we as Regulatory and Medical Writers leverage our roles to ensure the patient voice is accurately represented in submission documents and overall assessments of benefit-risk.

Growing up, we were taught as children that “sticks and stones may break our bones, but words may never hurt me.” Although we would like to believe that this time-tested adage is true, the reality is that words can and do hurt. How we use our words can have a significant impact on our communities. Those of us working in the clinical research field, including medical writers, can impact public health outcomes when describing study results and how we describe and characterize their experience in clinical research. During this presentation, I will explore how the use of stigmatizing language disproportionately impacts health access and equity for marginalized groups. I want to challenge us to take increased responsibility for eliminating health disparities and improving health equity across the spectrum.