Director, Medical Writing

All Jobs  >  Director, Medical Writing Apply Director, Medical Writing Fully Remote • Nationwide Apply Job Type Full-time Description ABOUT BRIDGEBIO ONCOLOGY THERAPEUTICS  BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information, visit BBOTx.com.WHO YOU AREThe Director, Medical Writing provides strategic and operational leadership for the Medical Writing function and is responsible for the planning, development, and delivery of high-quality clinical and regulatory documents that support BBOT's development programs and global regulatory submissions.This individual serves as a strategic partner to Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional leaders to ensure the timely delivery of scientifically rigorous and regulatory-compliant documentation. The Director is responsible for establishing medical writing standards, building organizational capabilities, and ensuring portfolio-wide execution of medical writing activities in support of corporate objectives. Requirements RESPONSIBILITIESMedical WritingDirect, hands-on authoring and leading complex, major regulatory document preparation (e.g., IND, NDA, BLA, and MAA, clinical protocol, IB, CSR, Agency meeting materials).Synthesize complex clinical and scientific data into key elements.Review and edit documents prepared by internal writers, contractors, or functional contributors to ensure quality and adherence to standards.Partner with study teams to develop key messages from clinical study data.Drive alignment across functions to ensure high-quality, timely, and efficient execution of clinical and regulatory documentation.Functional Leadership and StrategyDevelop and execute the Medical Writing functional strategy aligned with corporate and development objectives.Establish and maintain department goals, performance metrics, standards, and best practices to ensure high-quality and efficient document delivery.Build, scale, and continuously improve Medical Writing processes, systems, templates, and standards.Provide strategic leadership and oversight for all medical writing activities across the clinical portfolio.Serve as the functional leader and subject matter expert for Medical Writing within the organization.Portfolio and Regulatory LeadershipLead strategic planning and oversight of medical writing deliverables across all development programs and regulatory submissions.Influence development and regulatory strategies through active participation in portfolio planning and decision-making activities.Develop integrated document strategies and submission plans for major regulatory submissions, including INDs, NDAs, BLAs, MAAs, and health authority meeting packages.Partner with cross-functional teams to develop messaging strategies and ensure consistent communication of clinical data across regulatory documents.Provide strategic guidance on document content, structure, and messaging to support successful regulatory interactions and submissions.Ensure all deliverables are completed in compliance with applicable regulations, company SOPs, ICH guidelines, and industry standards.Organizational Leadership and Resource ManagementDevelop and manage Medical Writing resource plans, including internal staffing, contractor oversight, and vendor management strategies.Manage departmental budgets and forecasting activities to ensure efficient allocation of resources.Recruit, mentor, develop, and retain high-performing medical writing professionals.Provide leadership, coaching, and performance management for direct reports and contribute to succession planning and organizational development.Establish an effective operating model that...