Medical Writing Editor

Summary

Join Scholar Rock, a biopharmaceutical company, as a Medical Writing Editor. This newly created position involves overseeing and conducting quality reviews of clinical study and regulatory filing documents. You will ensure the delivery of clearly written and compliant documents. The ideal candidate possesses a passion for science and writing, experience editing complex scientific and medical material, and a team-centric collaborative mindset. Success requires exceptional communication skills and the ability to work well under pressure. This role offers the opportunity to contribute to the development of innovative treatments for serious diseases.

Requirements

• Bachelor of Science in a relevant scientific field, English, or Writing
• 7+ years of experience in an editor capacity for medical writing within the pharmaceutical/biotech industry
• Expert knowledge of AMA Manual of Style
• Expertise in medical terminology and technical writing
• Proven experience in medical or scientific writing or editing, excellent editing skills, and attention for detail
• Ability to work under tight deadlines
• Familiarity with regulatory guidelines and industry standards
• Proficiency in content management systems and editing tools
• Common sense

Responsibilities

• Edit documents in support of development programs
• Oversee and conduct quality reviews of clinical study and regulatory filing documents (eg eg , investigational new drug application and biologics license application components, briefing documents, package inserts, manufacturing reports) to ensure the delivery of clearly written, well-organized, accurate, concise (lean authoring), complete, and compliant submission-ready documents that contain a consistent message, support project goals, are consistent with the document template, and appropriate for their intended audience
• Perform copyediting for formatting, style, spelling, and grammar
• Perform content QC in documents. Ensure that results are an accurate interpretation of the data
• Create and maintain company- or program-specific document templates that are compliant with the latest guidance
• Create and maintain document-specific quality control (QC) checklists
• Update and maintain company Style Guide
• Develop quality standards for medical writing and associated training materials
• Develop training materials for document reviewers
• Coordinate Medical Writing inspection readiness activities
• Create and maintain Endnote libraries
• Track QC findings to identify opportunities for process improvement
• Outsource and manage QC work as needed; train vendors on Document Quality processes and quality standards

Preferred Qualifications

• Advanced degree in a relevant scientific field
• BELS or equivalent certification
• Experience with artificial intelligence tools for medical writing