Medical Writer II

Job not on LinkedIn

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $66.5k - $131.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Carry out medical writing activities on Phase I-IV studies for the USA, Europe, and Rest of World (ROW) • Prepare and lead the medical writing team on protocols, protocol amendments, informed consent documents and assents, clinical trial reports including efficacy sections, CTR narratives, Investigator Brochures, and other study documents • Prepare and lead the medical writing team on documents applicable in regions outside the USA, including IMPDs, Protocol Lay Summaries, CTR Lay Summaries, and assents • Contribute creative ideas, concepts, or suggestions to provide added value to projects • Work independently with minimal supervision and as part of a team • Coordinate internal and Sponsor document review cycles • Review and perform medical writing quality control review of documents as needed • Complete work in accordance with Sponsor specifications, regulatory requirements, Worldwide quality management documents, timelines, accuracy, efficiency, budget, and scientific and ethical standards

🎯 Requirements

• Excellent written and spoken English • Ability to accurately interpret data and express findings in a clear and concise written manner • Excellent project/time management and organizational skills • Ability to work independently and as part of a team • Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects • Comprehensive Microsoft Office skills, especially Word, PowerPoint, Excel, and Outlook • Ability to communicate with professionals from a variety of backgrounds • University/college degree in life science or related allied health profession, or equivalent combination of education and experience • Minimum of 3 years of Medical Writing experience or equivalent role as determined by management • Available for domestic and international travel, including overnight stays, with a valid passport

🏖️ Benefits

• Competitive benefits package depending on location • Transparent compensation and pay equity