Senior Associate, Quality Control

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Establish the parameters for quality control tasks with document authors and determine necessary source documents and data.

• Perform independent quality control evaluations of documents using relevant checklists and source materials.

• Ensure that results are precise and that quality control documentation is thorough, accurate, and uploaded to the master file.

• Keep up-to-date with clinical regulatory documents that require quality control reviews and associated business processes.

• Mentor and offer guidance and training to junior medical writing operations staff.

• Oversee and manage two or more contractors as assigned.

• Spearhead the development, execution, and upkeep of medical writing operations business processes.

• Serve as the subject matter expert for the master file system and quality control.

• Handle quality control outsourced to vendors, which includes training and preparing clinical documents and checklists.

• Convey quality control deliverables to stakeholders.

⛳️ Requirements

• A Bachelor’s degree is mandatory.

• 3–4 years of pertinent industry experience in quality control or review of clinical regulatory documents or similar fields.

• Familiarity with clinical documents and the eCTD structure.

• Understanding of drug development and the Common Technical Document (CTD) content templates.

• Working knowledge of global regulatory standards and guidelines for scientific publications or clinical regulatory documents.

• Ability to apply business processes, guidelines, standard operating procedures, work instructions, and job aids effectively.

• Project management experience is preferred.

• Demonstrated analytical and critical thinking abilities.

• Excellent oral and written communication, interpersonal, organizational, and conflict resolution skills.

• Exceptional attention to detail and ability to manage multiple tasks/projects.

• Experience in collaborating with cross-functional teams.

• Proficient in computer skills aimed at process improvements, operational efficiencies, and automation.

• Proficiency in Microsoft Office applications, including Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, and Word.

• Skilled in using Adobe within a Windows operating system environment.

• Proficient with Microsoft document file formats such as DocX, as well as publishing software and content management archival systems for eTMF/eSubmissions, including Veeva Vault and CARA.

• Capability to adapt to changing workloads and prioritize urgent business needs.

• Higher education may offset years of experience; conversely, years of experience may compensate for lesser educational qualifications.

🏝️ Benefits

• Paid time off (including vacation, holidays, and sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Availability for remote work.