Medical Writer

About the role

Celerion is searching for a full-time Medical Writer to work remotely. This position will analyze and interpret safety results of clinical trials, compile, write, and edit clinical study reports and other industry documents, and confirm accurate classification of events and medications using standardized coding systems.

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 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, ensuring the safety text fits into the CSR as a whole, and recommend 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 the 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 a 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 under pressure.
• Ability to multi-task and respond rapidly to changing priorities and aggressive timelines.
• Excellent communication and interpersonal skills.
• Knowledge of medical, pharmaceutical, and/or clinical research concepts preferred.

Celerion Values

• Integrity
• Trust
• Teamwork
• Respect