Medical Editor

Company Overview

Our client is a clinical-stage biotechnology company focused on developing innovative therapies for serious diseases, including oncology and other areas of significant unmet medical need.

Position Summary

Reporting to the Head of Medical Writing, the Medical Editor will be responsible for the editorial review and quality control of clinical and regulatory documents. This individual will ensure documents meet high standards for scientific accuracy, consistency, clarity, and compliance with industry guidelines. The role will also support document tracking and workflow management across the Medical Writing function to help ensure key deliverables remain on schedule.

Key Responsibilities

• Perform quality control reviews of clinical and regulatory documents, including clinical study protocols, protocol amendments, clinical study reports, briefing documents, regulatory response letters, and related submissions.
• Review documents for scientific accuracy, completeness, consistency, grammar, spelling, punctuation, and adherence to internal and external style guidelines.
• Verify data consistency between source tables, figures, listings (TLFs), and document text.
• Ensure documents meet industry standards for formatting, content quality, and reference management.
• Monitor document review workflows and provide status updates on active deliverables.
• Maintain visibility into document progress, timelines, milestones, and ownership across the Medical Writing team.
• Identify potential delays, timeline risks, or outstanding dependencies and escalate appropriately.
• Serve as a subject matter expert for document management and collaborative authoring platforms, including generating reports related to document review and approval status.
• Collaborate with Medical Writing and cross-functional stakeholders to facilitate document reviews and reconcile feedback.
• Support team processes, reference management, templates, tools, and best practices to drive consistency and operational efficiency.

Qualifications

• 5+ years of pharmaceutical, biotechnology, or CRO industry experience in medical editing, medical publications, or a related function.
• Experience supporting clinical and regulatory documentation within a clinical-stage organization.
• Familiarity with NDA, BLA, MAA, or other major regulatory submissions.
• Experience with collaborative authoring and document management platforms such as Veeva Vault, Documentum, or similar systems.
• Proficiency with PubMed, MEDLINE, and other scientific literature databases.
• Strong understanding of industry standards and regulatory document requirements.
• Scientific degree preferred.
• Exceptional attention to detail, organization, and process management skills.

Additional Information

This position offers the opportunity to work closely with cross-functional development teams in a collaborative and fast-paced environment while supporting critical clinical and regulatory milestones.