Senior Medical Writer - Remote

Overview

The Senior Medical Writer will be responsible for writing and editing clinical development documents, ensuring scientific rigor, and maintaining timelines while interacting directly with clients.

In Short

• Critically evaluate and interpret medical literature for study design.
• Write and edit clinical development documents including protocols and reports.
• Complete writing assignments in a timely manner.
• Maintain timelines and workflow of writing assignments.
• Provide excellent customer service internally and externally.
• Proficient in writing styles for regulatory documents.
• Interact independently with clients to coordinate projects.
• Mentor junior medical writers and project team members.
• Own assignments and consult with team members as needed.
• Manage production of interpretive guides.

Requirements

• 5+ years of experience in the pharmaceutical industry.
• 5+ years of regulatory writing and clinical medical writing experience.
• Bachelor's, Master's, or Ph.D. in a relevant scientific discipline.
• Experience as lead author on clinical study protocols.
• Ability to author regulatory documents under tight deadlines.
• Understanding of clinical data and exceptional writing skills.
• Excellent organizational and multi-tasking skills.
• Expert in MS Word, Excel, PowerPoint, and related tools.
• Experience managing project teams.
• Strong understanding of federal regulations and clinical practices.

Benefits

• Work with a leading CRO in the pharmaceutical industry.
• Opportunity for professional development and mentorship.
• Contribute to impactful clinical research.
• Flexible working environment.
• Collaborate with a global team.