Medical Writer
New
C
CelerionClinical research
Remote - USFull-TimeJunior
Salary not disclosed
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Job Details
- Experience
- 1-3 years experience in hospital/clinical setting or interpreting medical or clinical results.
- Required Skills
- SharePoint
Requirements
- Bachelor's degree and/or professional license in a medical or scientific field (RN, BS, RPh, MS, MPH), or equivalent experience.
- 1–3 years of experience in a hospital or clinical setting, or interpreting medical or clinical results.
- Professional writing and editing skills for accurate, concise reporting of clinical trial results.
- Ability to interpret and present data in a coherently written document.
- Detail-oriented, thorough, and methodical approach.
- Ability to work without close supervision and under pressure.
- Ability to multitask and respond rapidly to changing priorities and aggressive timelines.
- Knowledge of medical, pharmaceutical, and/or clinical research concepts is preferred.
Responsibilities
- Analyze and interpret medical results, including vital signs, clinical laboratory values, adverse events, ECGs, diagnostic procedures, and pharmacodynamic endpoints.
- Compile and write Phase I and Phase II clinical trial documents, including clinical study reports, stand-alone safety narratives, and synoptic CSRs.
- Review study results to assess whether safety objectives and endpoints were met, and accurately reflect the results in safety text.
- Perform peer quality control of safety text before its inclusion in clinical study reports.
- Review reports for completeness and accuracy, and recommend changes or rewrite text as appropriate.
- Lead report delivery as part of a multidisciplinary scientific team, ensuring quality and on-time delivery.
- Review editorial comments before incorporation to ensure report text is accurate and supports the objectives and endpoints.
- Ensure deliverables comply with applicable regulatory standards, including Good Clinical Practice and International Conference on Harmonisation guidelines, and client specifications.
- Use WebEx, Veeva, Microsoft 365, SharePoint, and SmartSheet to work with international teams.
- Lead project-related client communication and interact with internal departments.
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