Technical Writer

• Author and co-author CMC content for CTD Quality sections, ensuring alignment with regulatory strategy and scientific accuracy.
• Plan and lead submission kick-offs, managing detailed timelines, deliverables, and cross-functional collaboration.
• Coordinate and track submissions, including responses to Health Authority questions, data verification, and final dossier preparation.
• Partner with subject matter experts (SMEs) across CTDO to identify source documents, align on timelines, and deliver approved technical content.
• Ensure consistency, clarity, and accuracy of messaging across all CMC documentation.
• Review and reconcile comments with SMEs, manage revisions, and facilitate efficient comment resolution.
• Provide oversight for eCTD Modules 2.3 and 3, ensuring compliance with formatting, structure, and regulatory requirements.
• Collaborate with external partners as needed to review and finalize CTD content.
• Drive process improvements and contribute to best practices in regulatory writing and document management.
• Mentor and train team members on technical writing standards, systems, and submission processes.

Technical Writer – CMC Regulatory Submissions

Medical & Technical Writer, Sci Ops – JJMT Electrophysiology