Information Specialist

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

📋 Description

• Oversee the strategy and implementation of regulatory literature searches for significant submissions (e.g., SOTA, CER), guaranteeing that results are thorough, traceable, and in line with submission schedules.

• Maintain audit-ready documentation and ensure compliance by adhering to industry standards (e.g., PRISMA) while keeping meticulous records of methodologies, search strategies, and inclusion/exclusion criteria.

• Supervise the complete lifecycle of references and articles, including acquisition, tracking, deduplication, version control, and library organization within enterprise systems (e.g., EndNote/Distiller).

• Collaborate with teams across Scientific Communications, Regulatory Affairs, Clinical, and global Medical Affairs to provide high-quality, evidence-based support.

• Create concise evidence summaries and address complex information requests, facilitating consistent and accurate data usage in internal and regulatory materials.

• Promote process enhancements and knowledge management to boost efficiency, scalability, and internal ownership of literature and evidence activities currently managed by external vendors.

⛳️ Requirements

• Demonstrated experience in conducting structured literature searches utilizing biomedical databases such as PubMed/MEDLINE and Embase.

• Experience supporting systematic literature reviews, regulatory submissions, or clinical evaluations in pharmaceutical, medical device, or clinical settings.

• Proficiency in reference management tools and article tracking systems to maintain organized and accurate evidence libraries.

• Strong capability to collaborate effectively with cross-functional and global teams across Medical Affairs, Regulatory, and Clinical functions.

• Exceptional attention to detail with the ability to manage complex data sets and ensure accuracy, traceability, and consistency.

• Solid organizational and time management skills to manage multiple priorities and deadlines in a dynamic environment.

• Familiarity with utilizing AI tools to improve literature search efficiency, screening, and evidence summarization (preferred).

🏝️ Benefits

• A front row seat to life-changing CGM technology.

• Learn about our brave #dexcomwarriors community.

• A full and comprehensive benefits program.

• Growth opportunities on a global scale.

• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.