Quality & Operations Specialist

Job Description

The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (GCTO) creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.

The Quality & Operations Specialist manages the preparation, quality control, tracking, and submission of clinical and regulatory documents and transparency deliverables, while coordinating with stakeholders to ensure compliance, accuracy, and timely completion of regulated content.

Key responsibilities may include:

• 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.
• Coordinate clinical deliverables related to global regulatory submissions, including initiation, review, and finalization of Electronic Common Technical Document (eCTD) modules.
• Provide input and feedback to the standard operating procedures and work instructions with a mindset of process improvement and efficiency.
• Design and implement innovative, efficient processes and tools to enhance business operations, document organization, authoring workflows, and metrics collection.
• Coordinate the collection, reconciliation, analysis, and reporting of operational metrics to support decision-making and continuous improvement activities.

Qualifications

• Required: 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.

Required skills & 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 manage complex, ambiguous situations.
• 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.

Business Operations:

• Supports technology-enabled business operations by applying digital tools, automation, analytics, and cross-functional collaboration to improve Clinical and Regulatory Strategic Communications (CRSC) processes and outcomes.
• Experience with technology-enabled business operations, including SDLC, requirements, testing, implementation, and system support.
• Proficiency with Microsoft 365 tools, including SharePoint, Excel, Word, and Power Platform; understanding of AI and automation use cases.
• Analytical mindset with strong critical thinking, problem