Medical Writer - Global Clinical Development

Overview

Medical Writer supporting the Global Clinical Development organization's Medical Writing team, developing clinical study documents in a remote work model across therapeutic areas.

What you'll do

• Develop clinical documents including clinical study reports, protocols, informed consent forms, narratives, and investigator brochures.
• Manage and facilitate document completion with oversight from Medical Writing leads.
• Lead document activities for a compound when assigned.
• Drive document development meetings and support timeline execution.
• Articulate document strategy and document timelines.
• Identify appropriate stakeholders for content decisions and keep discussions progressing.
• Synthesize complex discussions into clear, accurate written content.
• Collaborate, help resolve issues, and escalate concerns when needed.

What you'll need

• Bachelor's degree.
• 1 year of relevant experience.
• Awareness of the clinical research process and applicable regulations and guidelines.
• Scientific and technical reading, writing, and editing skills.
• Experience following internal standards, procedures, templates, and peer-review practices.
• Knowledge of guidelines, templates, and standard operating procedures for Medical Writing documents.
• Working knowledge of Microsoft Word, Adobe Acrobat, and PowerPoint.
• Familiarity with electronic document management systems.
• Strong organizational, interpersonal, and communication skills.
• Ability to maintain current knowledge of industry standards and complete required training.

Nice to have

• Advanced degree.

Details

• Location: United States - Remote.
• Work model: Remote.