Medical writer

• Independently prepares, edits, and finalizes Protocols including amendments, addenda, and notes to file, original and updated Investigator’s Brochures, Clinical Study Reports (full and abbreviated), as well as other regulatory documents (INDs/NDAs, annual reports, Orphan Drug Designation applications, Agency Response to Questions, Briefing Books) with minimal input.
• Coordinates and leads comment adjudication meetings.
• Develops, manages, and communicates project timelines.
• Ensures appropriate and effective collaboration with key functional contributors and adherence to ICH and other regulatory requirements, in addition to internal Arcus document standards.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and to align key messaging for CSR and submission document development.
• Serves as MW point-of-contact to internal cross functional teams and Arcus partners in support of medium-to-large development programs and initiatives.
• Participates in MW and cross-functional process improvement initiatives on clinical document standards, template development, and document or MW processes.
• Reviews documents written by less experienced or contract medical writers.
• Coordinates Quality Review (QR) of documents, addresses comments, and maintains audit trails of changes.
• May perform QR review if requested (eg, QR in-text tables against statistical tables, verify titles in standard table of contents, paginate a document, etc).
• Coordinates communication with document processing and ensures template formatting aligns with Arcus quality standards.
• May provide oversight of vendors, vendor resources, and contracts.

Principal Medical Writer

Clinical Documentation Integrity Specialist – 2nd Level Reviewer

Principal Medical Writer

Clinical Documentation Specialist

RN Clinical Documentation Specialist

Clinical Documentation Specialist