Senior Manager, Medical Writer
Spyre Therapeutics
Job Level
Junior
Tech Stack
Swift
About the role
- 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.
- Currently lives in the United States.
