Medical Writing Support Specialist

About the Role

Key Responsibilities

• Processes, proofreads, verifies, and manages various clinical regulatory documents to ensure they are submission-ready with accuracy and consistency.
• Communicates regularly with colleagues and management regarding timelines, conflicts, and document completion statuses.
• Provides ongoing support to Medical Writing, Clinical, and other functional areas, acting as a liaison between eDocs support and Medical Writing.
• Ensures electronic document deliverables are processed and completed in alignment with established timelines.
• Ensures document styles and formatting are consistent with defined eSubmissions standards and clinical regulatory templates.
• Populates document properties and ensures correct naming conventions are used according to eSubmissions System standards.
• Maintains accurate and timely document tracking and verifies literature citations.
• Performs literature searches and maintains knowledge of eSubmissions styles and formatting standards.
• Participates in process improvement activities and stays compliant with current industry requirements related to regulatory submissions.

Requirements

• Minimum of 3 years of relevant industry experience within medical writing in a global pharma, biotech, life science, or federal agency organization.
• Experience in medical writing, word processing, and regulatory documentation.
• Familiarity with clinical protocols, clinical study reports, and electronic submission standards.
• Ability to process, proofread, verify, and manage clinical regulatory documents with accuracy.
• Strong communication skills for effective collaboration with team members and management.
• Knowledge of eSubmissions styles, formatting standards, and document tracking procedures.

Nice to Have

• Experience with electronic document management systems and document properties.
• Knowledge of industry-specific regulatory standards and electronic submission/approval processes.

Qualifications

• 3-5 years of relevant industry experience in medical writing or related fields.

Benefits & Perks

• Remote work environment.