Medical Writing Coordinator/Publisher III - Remote

Overview

The Medical Writing Coordinator/Publisher III is responsible for document publishing in eSubmission systems, ensuring compliance with regulatory standards, and managing communication with medical writing teams.

In Short

• Expertise in document publishing in eSubmission systems & publishing software.
• Compile, publish, verify, & quality-check various reports.
• Effective communication with medical writing & related teams.
• Assist with implementation of publishing software updates.
• Manage outsourced vendor work.
• Lead process improvements and manage schedules.
• Maintain process documents and training materials.
• Train junior staff.
• Meet timelines & regulatory standards.
• Adhere to deadlines and resolve issues.

Requirements

• Bachelor's in Science, English, or Communications.
• 3 years of document publishing industry experience.
• Experience with clinical & regulatory documents.
• Knowledge of content management systems.
• Experience with DocuBridge, ISI toolbox, & Adobe Pro DC.
• Understanding of ICH E3 & 21 CFR 11 requirements.
• 1 year of mentoring experience.
• Ability to work in a matrixed organization.
• Strong communication and organizational skills.
• Ability to manage workload scheduling.

Benefits

• Paid time off (vacation, holidays, sick).
• Medical/dental/vision insurance.
• 401(k) plan for eligible employees.
• Participation in short-term and long-term incentive programs.