Full-Time Medical Writing Editor

Scholar Rock is a biopharmaceutical company focused on developing life-changing therapies for serious diseases. They are advancing innovative treatments using protein growth factors.

Summary: The Medical Writing Editor will oversee and conduct quality reviews of clinical study and regulatory filing documents to ensure they are clearly written, compliant, and ready for submission.

Responsibilities:

• Edit documents supporting development programs.
• Review clinical study and regulatory documents (e.g., IND, BLA components, briefing documents, package inserts).
• Ensure documents are clearly written, well-organized, accurate, concise, complete, and compliant.
• Maintain document templates and quality control checklists.
• Update and maintain the company Style Guide.
• Develop quality standards and training materials for document reviewers.
• Coordinate Medical Writing inspection readiness activities.
• Manage outsourced QC work and vendor training.

Qualifications:

• Advanced degree (preferred) or Bachelor's in a scientific field, English, or Writing (required).
• 7+ years of experience as a medical writing editor in the pharmaceutical/biotech industry.
• BELS or equivalent certification preferred
• Expert knowledge of AMA Manual of Style.
• Expertise in medical terminology and technical writing.
• Strong editing skills and attention to detail.
• Experience with regulatory guidelines and industry standards.
• Proficiency in content management systems and editing tools.
• Experience with AI tools for medical writing (preferred).

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