Medical Writer II, Oncology

Medical Writer II supporting oncology regulatory documentation within Johnson & Johnson's Integrated Data Analytics & Reporting business. The role involves authoring diverse regulatory medical writing documents across early- and late-stage compounds, working in cross-functional teams with increasing independence.

Responsibilities

• Author and coordinate clinical documents including protocols, CSRs, and investigator's brochures
• Conduct quality control, literature searches, and maintain document abbreviations and references
• Lead cross-functional document planning and review meetings as appropriate
• Track project timelines, scheduling, and document strategy execution
• Mentor junior staff and guide team members on medical writing processes and best practices

Requirements

• Medical writing experience in regulatory or clinical documentation
• Knowledge of pharmaceutical regulatory guidelines and industry standards
• Proficiency with medical writing tools, systems, and SOPs
• Strong written and verbal communication skills
• Ability to work collaboratively in matrix team environments
• Experience with clinical study reports, protocols, and regulatory submissions