Medical Writer - Clinical Regulatory Documentation

Objective Reporting to the Head of Medical/Regulatory Writing, the Medical Writer – Clinical Regulatory Documentationwill be responsible for the preparation and delivery of high-quality, scientifically accurate, and regulatory-compliant clinical/medical documentation to support clinical development and regulatory submissions. This role will collaborate with cross-functional teams to author clinical/regulatory documents, including protocols, clinical study reports (CSRs), investigator brochures (IBs), and clinical modules for INDs/CTAs, NDAs/MAAs, and other regulatory documents. Essential Functions Medical Writing: Author clear, concise, and scientifically accurate clinical documents, including but not limited to clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), clinical trial documents, and Modules for regulatory submissions (INDs, NDAs/MAAs, etc.). Cross-Functional Collaboration: Work closely with clinical development, regulatory affairs, and other stakeholders (e.g., nonclinical, CMC etc) to ensure that all medical writing deliverables meet project objectives, timelines, and regulatory requirements. Regulatory Compliance: Ensure all documents are in compliance with applicable global regulatory requirements (e.g., FDA, EMA, ICH guidelines) and adhere to internal standards and best practices. Document Review and Revision: Participate in the review and revision of clinical documents based on feedback from internal stakeholders and external regulatory bodies. Ensure that documents are well-organized, accurate, and aligned with regulatory expectations. Quality Assurance: Assist in maintaining high-quality standards for all clinical documentation. Ensure consistency, accuracy, and scientific rigor in all written materials. Project Support: Provide medical writing support across various stages of clinical development, including early-phase studies, late-stage clinical trials, and regulatory submissions. Manage the preparation of documents w