Medical Writer

🕒 July 24

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🏥📝 Medical Writer

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Celerion

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1971

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celerion is a global leader in clinical research services with a focus on accelerating drug development through translational medicine. The company offers a range of services including early phase clinical trials, bioanalytical sciences, PK/PD studies, biomarkers, and regulatory affairs. Celerion is dedicated to getting drugs to market faster by leveraging their experience and innovative research strategies. Their expertise covers various therapeutic areas such as oncology, metabolic and respiratory diseases, biosimilars, and vaccines. With over 40 years of experience, Celerion has been recognized for their leadership in the clinical research organization (CRO) space and is committed to science and technology-driven innovations that advance healthcare solutions globally.

📋 Description

• 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