Senior Associate, Quality Control

About the Role

The Strategic Medical Writing Operations Team is dedicated to delivering high-quality, scientifically accurate, and strategically aligned clinical and regulatory documentation that supports AbbVie's mission to transform the standard of care. The team serves as a critical link between research, development, and regulatory submissions, ensuring clarity and compliance in all clinical and regulatory documents. We strive to innovate and enhance medical writing processes through cross-functional collaboration, agile methodologies, and cutting-edge technology.

Responsibilities

• Defines scope of quality control activities with the document author and identifies required source documents and data.
• Conducts independent quality control review of documents per applicable checklist by verifying accuracy against source documents.
• Ensures quality control documentation is complete, accurate, and uploaded to the master file per established business processes.
• Maintains strong knowledge of clinical regulatory documents requiring quality control review and related business processes.
• Mentors and provides guidance and training to less senior medical writing operations staff members.
• Provides management and oversight/supervision of 2 or more contractors as delegated.
• Leads the development, implementation, and maintenance of medical writing operations business processes.
• Acts as subject matter expert (SME) for the master file system and quality control to medical writing stakeholders.
• Manages quality control outsourced to vendors, including providing training and preparing required documentation (e.g., clinical documents, checklists).
• Effectively communicates quality control deliverables to stakeholders.
• Demonstrates strong interpersonal and organizational communication skills, including conflict management.

Requirements

• Bachelor’s degree required; degree in Science, English, or Communication preferred.
• 3-4 years of relevant industry experience in quality control/review of clinical regulatory documents or related experience in quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D. (Note: Higher education may compensate for years of experience, and vice versa.)
• Project management experience preferred.
• Excellent knowledge of the organization and content of clinical documents and eCTD structure.
• Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
• Working knowledge of global regulatory requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
• Competence/expertise in applying business processes (guidelines, standard operating procedures, work instructions, job aids, etc.).
• Ability to adapt to changing workloads requiring prioritization and planning to support immediate/urgent business needs.
• 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.
• Demonstrates a higher degree of proficiency, skill, and knowledge than junior-level staff.
• Computer literacy and technical skills to apply toward process improvements, operational efficiencies, and automation.

Skills

• Proficient in Microsoft Office Products (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe in a Windows operating system environment.
• Proficient in Microsoft document file formats (DocX) or other style file format tools.
• Experience with publishing software and content management archival systems for eTMF/eSubmissions (e.g., Veeva Vault, CARA).

Benefits

• Comprehensive package including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in short-term incentive programs.