ObjectiveThe Senior Director, Medical Writing provides strategic leadership and accountable oversight of the end-to-end medical writing function to deliver high-quality, inspection-ready regulatory and scientific documents across all stages of development.This role serves as the accountable medical writing lead for regulatory submissions and document strategy (authorship planning, sequencing, and content alignment), providing oncology-focused expertise while driving quality, timelines, and review-cycle efficiency through KPIs, best practices, and effective vendor and resource management. The Senior Director partners with cross-functional leaders to enable program-level decision-making and ensure submission readiness and consistency across deliverables. In the near term, this is a hands-on role and will personally author and/or lead the drafting and finalization of key documents while the medical writing team is scaled.Essential FunctionsStrategic Leadership & Functional OwnershipOwn the end-to-end medical writing function, including planning, resourcing, execution, and delivery of regulatory and scientific documents across all stages of development.Provide strategic input into development and regulatory strategy through authorship planning, document sequencing, and content alignment.Initially serve in a hands-on capacity by personally authoring and/or leading the drafting, review, and finalization of core regulatory and scientific documents, while building and scaling the medical writing function over time.Serve as the accountable medical writing lead for regulatory submissions, ensuring consistency, completeness, and submission readiness across all deliverables.Act as the primary medical writing representative in cross-functional governance forums and program-level decision-making.Regulatory & Document LeadershipLead the development of complex, integrated regulatory documents as programs advance, including INDs, NDAs, MAAs, briefing documents, and responses to regulatory authorities.Provide senior-level leadership in the development of clinical trial protocols, clinical study reports, Investigator Brochures, periodic safety updates, safety narratives, and scientific publications.Provide expert guidance on oncology-specific documentation, including oncology protocols, and benefit-risk assessments.Ensure alignment with ICH, FDA, EMA, and other global regulatory standards.Establish best practices, templates, and document standards to enhance consistency, quality, and efficiency.Quality, Compliance & Operational ExcellenceEnsure all written materials meet regulatory requirements, company SOPs, and inspection-ready standards, and support regulatory inspections and audits related to clinical and regulatory deliverables.Establish and monitor key performance indicators (KPIs) for medical writing quality, timelines, and review cycle efficiency.Develop and implement quality control processes to enhance document accuracy, clarity, and compliance.Lead continuous improvement initiatives to optimize medical writing processes and cross-functional collaboration.Vendor & Resource ManagementLead the selection, onboarding, and oversight of external medical writing vendors, ensuring quality, consistency, and adherence to company standards.Manage internal and external resourcing strategies to meet program timelines and corporate milestones.Cross-functional Collaboration & Team LeadershipPartner closely with clinical development, regulatory affairs, biostatistics, pharmacovigilance, and other stakeholders to ensure seamless integration of medical writing into development programs.Lead and mentor a team of medical writers, fostering technical excellence, accountability, and professional development.Cultivate a culture of collaboration, innovation, and high performance within the medical writing function.Therapeutic Expertise & Thought LeadershipServe as a subject matter expert in oncology medical writing, maintaining current knowledge of scientific, clinical, and regulatory advancements.Represent the medical writing function in internal and external interactions, including regulatory meetings, advisory boards, and industry forums.Qualifications
