Celerion is committed to swift, exceptional clinical research through translational medicine.
Full-time Medical Writer, home based anywhere in the United States; Canada and non-US candidates will not be considered.
Analyze and interpret safety results of clinical trials, including vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and pharmacodynamic (PD) endpoints.
Compile, write, and edit Phase I and Phase II clinical study documents including clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs.
Confirm accurate classification of events and medications using standardized coding systems.
Perform peer QC of safety text, serve as project Report Lead, monitor editorial comments, and ensure regulatory compliance (GCP, ICH) and client specifications.
Use technology to collaborate with international teams (Veeva, Microsoft 365, SharePoint, SmartSheet), lead client communications, and interact with internal departments.
Requirements
Bachelor's degree and/or professional license in a medical or scientific field (RN, BS, MS, MPH) required or equivalent experience.
1-3 years experience in hospital/clinical setting or interpreting medical or clinical results.
Professional writing and editing skills for accurate and concise reporting of clinical trial results; ability to interpret and present data in preparing a coherently written document.
Detail-oriented, thorough, and methodical.
Ability to work without close supervision and ability to work under pressure.
Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
Excellent communication/ interpersonal skills.
Knowledge of medical, pharmaceutical, and/or clinical research concepts preferred.