• Lead projects, submissions and documentation for programs independently. Collaborate with manager and other functions on planning and appropriate resourcing. • Provide medical writing strategy to program teams, ensuring business goals and regulatory needs are met. • Author key clinical, nonclinical and regulatory documents, including but not limited to clinical study protocols, amendments, IBs, CSRs, data summaries, CTD summaries, briefing books and meeting responses. • Develop timelines in collaboration with our team. Plan for required data with SMEs, if applicable. • Co-author documents with relevant cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments). • Coordinate QC, finalization and publication of documents • Review or contribute to supporting study documents, including but not limited to informed consent forms, study charters, or pharmacy manuals, if required. • Ensure key messages are clear and consistent across and within documents. • Represents the medical writing function in cross-functional teams. • Provide status updates to keep teams, department, and leadership informed. • Identify risks and contribute to risk mitigation or contingency planning for submission activities. • Possible oversight of contract medical writers, ensuring high-quality documents delivered and timelines met. • Proactively contribute to process improvements and standards across the team. Develop or maintain document templates, job aids, tools, and training materials. • Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review.