Senior Associate, Quality Control

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $84.5k - $162k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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AbbVie

WebsiteLinkedInAll Job Openings

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 quality control activities with document authors and identify required source documents and data • Conduct independent quality control reviews of documents against applicable checklists and source documents • Ensure results are accurate and quality control documentation is complete, accurate, and uploaded to the master file • Maintain knowledge of clinical regulatory documents requiring quality control review and related business processes • Mentor and provide guidance and training to less senior medical writing operations staff • Provide management and oversight of two or more contractors as delegated • Lead the development, implementation, and maintenance of medical writing operations business processes • Act as subject matter expert for the master file system and quality control • Manage quality control outsourced to vendors, including training and preparation of clinical documents and checklists • Communicate quality control deliverables to stakeholders

🎯 Requirements

• Bachelor’s degree required • 3–4 years of relevant industry experience in quality control/review of clinical regulatory documents or related areas • Knowledge of clinical documents and eCTD structure • Knowledge of drug development and Common Technical Document (CTD) content templates • Working knowledge of global regulatory requirements and guidance for scientific publications or clinical regulatory documents • Competence applying business processes, guidelines, standard operating procedures, work instructions, and job aids • Project management experience preferred • Proven analytical and critical thinking skills • Strong oral/written communication, interpersonal, organizational, and conflict management skills • Superior attention to detail and ability to prioritize multiple tasks/projects • Experience working with collaborative cross-functional teams • Computer literacy and technical skills for process improvements, operational efficiencies, and automation • Proficiency in 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 such as DocX, publishing software, and content management archival systems for eTMF/eSubmissions, including Veeva Vault and CARA • Ability to work with changing workloads and prioritize immediate or urgent business needs • Higher education may compensate for years of experience; years of experience may compensate for lower education

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Remote work availability