steven graham

Facilitated clinical trial (CT) delivery teams follow new pathways and mitigate “findings” arising from regulatory agency inspections. Working with a Global R&D’s Clinical Development Services (CDS) – a key stakeholder in CT delivery who facilitate CT deliverables and help teams prepare for regulatory agency inspections - developed high-level “Playbook” to support communication of how CDS is organized, its key roles and responsibilities across the stages of trial delivery and inspection preparation. Mapped key CDS interactions with Global Clinical Operations (GCO), cross-functional Study Execution Team, other Global Development Office (GDO) functions, R&D Quality Assurance and external partners (e.g., Contract Research Organizations). Developed Inspection Pipeline Dashboard (IPD) to provide monthly status updates of readiness/preparation for expected and confirmed regulatory agency inspections. These clear and concise communication tools were launched at GCO/GDO meetings and rolled out to key stakeholders

Developed materials to facilitate onboarding of new joiners for US Medical Strategy & Operations Team – interviewed key US Medical stakeholders (recently onboarded employees, hiring managers, HR, Executive Assistants, Function leads, etc.) to determine key resources and insights. Adapted existing materials and worked with function leads to create new materials. Developed introductory whiteboard videos and created a dedicated SharePoint site for new joiners with brief explanations that hyperlinked to the functionally-maintained/specific resources. Developed individual role-specific learning curricula for new joiners (also hyperlinked from Site). During beta-testing with key stakeholders it was felt that this site would also be valuable to experienced employees (not just new joiners) as a well-organized repository of resources used in daily activities

The Site launched just prior to and was showcased at a Senior Leadership Meeting where it met with much enthusiasm, and the Site’s Yammer feed and community remains active

Developed new operating model for Global Product and Launch Strategy (part of Global Commercial organization) – conducted portfolio mapping exercise, analysed needs and interviewed key stakeholders to collect data. Developed new operating framework and socialized the solution with senior leadership teams. Developed RACI/roles and responsibilities matrices and best practice case studies and worked with operational working groups to ensure adoption of the new framework