Remote Medical Writer - CSR & Safety Data Expert

Celerion; Phoenix (AZ); Remote; USD 70,000 - 100,000; Full time

Job summary

Celerion is seeking a full-time Medical Writer to work remotely, analyzing and interpreting safety results from clinical trials and compiling/editing CSR and other documents. The role requires coordinating with data management, project management, and other departments to ensure accuracy and regulatory compliance.

Responsibilities include peer QC of safety text, timely delivery of scientific reports, and effective communication with clients.

Qualifications

• Bachelor's degree in a medical or scientific field or equivalent experience.
• 1–3 years of hospital/clinical experience or clinical results interpretation.
• Professional writing and editing skills for reporting clinical trial results.
• Detail-oriented, thorough, and methodical.
• Ability to work independently and under pressure.
• Strong communication and interpersonal skills.
• Knowledge of medical/pharmaceutical concepts preferred.

Responsibilities

• Analyze and interpret all types of medical results including vital signs, lab values, adverse events, ECGs and PD endpoints.
• Compile and write Phase I/II CSR documents and safety narratives.
• Perform QC of safety text prior to CSR inclusion and suggest changes.
• Act as project lead to ensure quality and on-time delivery of reports.
• Monitor editorial comments to ensure accuracy and alignment with objectives.
• Ensure deliverables comply with GCP, ICH guidelines and client specs.
• Collaborate with international teams using WebEx, Veeva, MS365, SharePoint and SmartSheet.
• Lead project-related client communication and coordinate with data management and PM teams.
• Participate in activities that support department goals.

Skills

Technical writing

Editing skills

Medical writing

Communication

Attention to detail

Time management

Education

Bachelor's degree in medical/science field

Tools

WebEx

Veeva

Microsoft 365

SharePoint

SmartSheet

Job description

Celerion is seeking a full-time Medical Writer to work remotely, analyzing and interpreting safety results from clinical trials and compiling/editing CSR and other documents. The role requires coordinating with data management, project management, and other departments to ensure accuracy and regulatory compliance.

Responsibilities include peer QC of safety text, timely delivery of scientific reports, and effective communication with clients.