Quality & Operations Specialist

Key Responsibilities

• Coordinate the review, quality control, and/or redaction of clinical documents across multiple therapeutic areas and development stages, verifying accuracy, consistency, and proper formatting consistent with ICH, regulatory guidance, and privacy/transparency regulations.
• Manage deliverables timelines to keep a record of process activities and participate in submission planning meetings as needed to ensure timely completion of submission deliverables.
• Reference and track trial and submission information (e.g., clinical trial applications, new drug applications) via associated milestones, documents, and submission management systems to identify trials and submissions in scope of the transparency regulations.
• Facilitate collaborative review with authors and product development team members to ensure the information and documentation is reviewed and approved for accuracy, and, as applicable, for confidential and privacy protection.
• Manage the submission of transparency deliverables to public registries and health authorities within compliance timelines.
• Career Development and Professional Growth
• Coordinate the collection, reconciliation, analysis, and reporting of operational metrics to support decision-making and continuous improvement activities.

Qualifications

• Associate degree preferably in health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and/or at least 10 years of relevant experience for this role.
• Preferred: Bachelor’s degree preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 2 years of relevant industry experience.
• Fluent in American English.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat, SharePoint, and electronic document management systems.
• Strong project management, organizational, and multitasking abilities.
• Excellent communication, interpersonal, and collaboration skills with the ability to work independently and in cross-functional teams.
• Analytical mindset with problem-solving skills and ability to meet deadlines under pressure.
• Commitment to quality, attention to detail, and ability to meet deadlines under pressure.
• Adaptability to evolving technologies and processes within CRSC and regulatory environments.
• Able to maintain confidentiality and adhere to regulatory and company standards.
• Experience writing or general understanding of the content of drug and/or device clinical submission documents.

Required Skills & Experience

• Accountability
• Adaptability
• Business Operations
• New Technology Integration
• Power Platform
• Project Management
• Standard Operating Procedure (SOP)
• Technology Adaptation
• Working Independently