Medical Writer
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Job Description
Medical Writer analyzing and interpreting safety results of clinical trials at Celerion. Compiling, writing, and editing clinical study reports and other documents on a remote basis.
Responsibilities:
- Analyze and interpret all types of medical results including, but not limited to the following: vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and various pharmacodynamic (PD) endpoints.
- Compile and write Phase I and Phase II clinical trial documents including, but not limited to the following: clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs.
- Review/evaluate study results to determine whether or not the safety objectives and/or endpoints were met, accurately reflecting the results in the safety text.
- Perform peer QC function of safety text prior to inclusion in the CSR.
- Review reports for completeness and accuracy assuring that the safety text fits into the CSR as whole and recommending changes or rewriting, as appropriate.
- As the project Report Lead on a multi-disciplinary scientific team, ensure quality and on-time delivery of scientific reports.
- Monitor content of editorial comments received prior to incorporation into the report to assure report text comments are accurate and support the objectives and/or endpoints.
- Assure deliverables are compliant with applicable regulatory standards (i.e. Good Clinical Practice, International Conference on Harmonisation guidelines) and client specifications.
- Use technology to work with international teams (e.g., WebEx™,Veeva, Microsoft® 365 applications, SharePoint®, and SmartSheet).
- Lead-Project-related client communication.
- Interact with internal departments (e.g. data management, project management, business development, etc.).
- Participate in functions required to ensure success of department and/or market segment team.
Requirements:
- Bachelor's degree and/or professional license in a medical or scientific field (RN, BS, RPh, 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.
Benefits:
- Celerion Values: Integrity, Trust, Teamwork, Respect
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