Medical Writer

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, ensoure 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.