Medical Writer

Responsibilities

• Analyze and interpret all types of medical results including 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 clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs.
• Review/evaluate study results to determine whether 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 a 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 (e.g., 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).
• 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.