Medical Writing Coordinator – Publisher I

🔥 20 hours ago

🌽 Illinois – Remote

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💵 $58.7k - $103.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

✏️ Content Writer

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

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👻 Ghost score 0%

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Define the scope of formatting, report publishing, and Clinical Study Reports (CSR) Appendices activities with document authors • Coordinate and track activities and perform detailed quality reviews • Import and route documents in regulatory information management systems (RIMS) • Ensure document formatting, styles, properties, and naming conventions comply with RIMS standards and clinical and regulatory templates • Publish documents in the RIMS content management system within required timelines • Maintain knowledge of RIMS and publishing tools/software • Confirm completeness of documents such as Casebooks and Literature References by compiling and organizing them in RIMS • Maintain knowledge of CSR, CSR Appendices, and CTD structure • Contribute to the development, implementation, and maintenance of medical writing operations processes • Act as subject matter expert for the master file system and formatting, report publishing, or CSR Appendices • Communicate deliverables to stakeholders • Assist with management of the centralized mailbox • Track and maintain metrics and assist with training documents • Mentor and provide guidance and training to less senior medical writing operations staff • Work requires continuous sitting for prolonged periods, more than two consecutive hours in an eight-hour day

🎯 Requirements

• High School diploma required • Minimum of 2 years of relevant industry experience within medical writing in a global pharma, biotech, life science, or federal agency organization • Experience delivering medicines or therapies across various therapeutic areas • Knowledge of clinical document organization and content and eCTD structure • Knowledge of drug development and Common Technical Document (CTD) content templates • Outstanding written and oral communication skills • Comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas • Detail-oriented with commitment to high-quality, accurate, and compliant documentation • Strong communication, collaboration, and organizational skills • Ability to work independently and as part of a team • Proficiency with Microsoft Office products, including Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, and Word • Proficiency with Adobe in a Windows operating system environment • Proficiency with Microsoft document file formats (DocX), style file format tools, publishing software, and content management archival systems for eTMF/eSubmissions such as Veeva Vault and CARA • Proficiency with reference management software such as EndNote

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Eligibility to participate in short-term incentive programs • Equal opportunity employer • Reasonable accommodation for US and Puerto Rico applicants

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