Senior Associate / Manager - Medical Literature Review

Key Skills:

Roles & Responsibilities:

• Lead and manage the Medical Literature Review team, ensuring alignment with organizational goals and regulatory compliance.
• Develop and execute targeted literature search strategies based on clinical protocols, product names, and relevant criteria to support CERs, SotA reviews, and safety/performance evaluations.
• Liaise with vendors and publishers to resolve technical issues and communicate service-impacting changes across the organization.
• Manage the acquisition, tracking, and analysis of journal usage data to support subscription and selection decisions.
• Retrieve full-text articles from Reprints Desk bounce backs to maintain uninterrupted literature access.
• Prepare and deliver training sessions and tutorials to enhance end-user proficiency with knowledge center tools.
• Provide usage reports to the Copyright Clearance Center (CCC) and ensure compliance with licensing agreements.
• Respond promptly to internal stakeholder inquiries received via the Ask AKC mailbox, ensuring timely and accurate communication.
• Oversee day-to-day team operations, prioritize workloads, and foster a collaborative, high-performance work environment.
• Conduct annual and ad-hoc literature queries for both clinical and non-clinical reports in partnership with Regulatory Affairs.
• Support Medical Safety, Complaint Intake, and HEOR teams with targeted literature evidence and summaries.
• Perform summarization and risk analysis from publications to identify new complaints or safety concerns and update relevant systems.
• Ensure all processes are executed per Standard Operating Procedures (SOPs) and company compliance guidelines.
• Maintain up-to-date knowledge of ophthalmic terminology, anatomy, and disease procedures relevant to ongoing projects.
• Collaborate effectively across global time zones, supporting cross-functional and international teams.
• Review data entries, follow-up documentation, and reports for accuracy, completeness, and timeliness.
• Participate in audit and reconciliation activities and proactively identify emerging safety issues or process improvement opportunities.

Experience Required:

• 6 - 13 years of experience in conducting and managing medical literature reviews using PubMed, Medline, and Embase.
• Leading teams in systematic search, screening, and summarization processes for clinical and regulatory documentation.
• Working with Regulatory Affairs, Medical Safety, and Clinical teams to support CERs and risk assessments.
• Managing compliance, copyright reporting, and vendor relationships with external publishers or content providers.
• Handling scientific data interpretation and identifying trends or adverse events from published literature.
• Exposure to ophthalmic research or medical device literature is an added advantage.

Education: