Medical Writer

🕒 July 24

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🏥📝 Medical Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 43%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 111 days.
• Jobs at this company usually fill in 38 days.
• Reposted once.
• No salary listed.

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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 medical results, including vital signs, clinical laboratory values, adverse events, ECGs, diagnostic procedures, and pharmacodynamic endpoints • Compile and write Phase I and Phase II clinical trial documents, including clinical study reports, stand-alone safety narratives, and synoptic CSRs • Review and evaluate study results to determine whether safety objectives and endpoints were met • Perform peer quality control of safety text before inclusion in clinical study reports • Review reports for completeness and accuracy and recommend changes or rewriting • Serve as project Report Lead on multidisciplinary scientific teams, ensuring quality and on-time delivery • Monitor editorial comments for accuracy and alignment with objectives and endpoints • Ensure deliverables comply with Good Clinical Practice, International Conference on Harmonisation guidelines, and client specifications • Use WebEx, Veeva, Microsoft 365, SharePoint, and SmartSheet with international teams • Lead project-related client communication • Interact with data management, project management, business development, and other internal departments • Participate in functions supporting department and market segment team success

🎯 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 under pressure • Ability to multi-task and respond rapidly to changing priorities and aggressive timelines • Excellent communication/interpersonal skills • Knowledge of medical, pharmaceutical, and/or clinical research concepts preferred

🏖️ Benefits

• Equal Opportunity Employer • Remote work arrangement

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