Celerion is hiring a
Medical Writer

Summary

Join Celerion as a full-time Medical Writer to work remotely and contribute to swift clinical research through translational medicine. Analyze medical results, compile clinical study reports, and confirm accurate classification of events and medications.

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

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 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
• 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
• Proactively communicate with other members of the multi-disciplinary team to ensure medical writing quality and on-time delivery of the report
• Classify and confirm accurate classification of events and medications using standardized coding systems such as the World Health Organization Drug Dictionary (WHO DD), Medical Dictionary for Regulatory Activities (MedDRA®), and Common Terminology Criteria for Adverse Events (CTCAE)
• Use technology to work with international teams (e.g., WebEx™, Microsoft® SharePoint®, and Microsoft® Office® applications)
• Interact with clients as needed
• 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

Preferred Qualifications

Knowledge of medical, pharmaceutical, and/or clinical research concepts preferred