Acumen seeks an experienced Senior Regulatory Medical Editor as a contract role to ensure editorial quality, consistency, and compliance across regulatory submissions (NDAs, BLAs, INDs, and related scientific documentation). In this role, you will collaborate closely with medical writers and regulatory leads to refine submission deliverables to an exceptional editorial standard. The ideal candidate has extensive regulatory editing experience, deep familiarity with scientific and medical terminology, strong editorial judgment, and the ability to quickly step into ongoing submissions and deliver polished, submission-ready documents with minimal onboarding. Key Responsibilities Partner with the authoring medical writer to align on the scope and specifications of the editorial/quality review.Line-edit and format documents to ensure cohesiveness and internal consistency.Align content to pre-set templates, regulatory guidance, or style guides.Perform data checks against source documents, including tables, listings, and figures.Update/add references using EndNote or other reference management software.Provide concise and clear editing suggestions to the authoring medical writer.Create submission-ready PDFs with all internal links and bookmarks.Ensure grammatical accuracy, standardized terminology, and adherence to AMA, ICH, and sponsor-specific standards.Cross-check content for fidelity to source data and ensure alignment with eCTD structural expectations.Track revisions and maintain document integrity throughout the review cycle. Qualifications 510+ years of experience editing regulatory, clinical, or scientific documentation within pharmaceutical or biotech environments.Proven editorial support for major regulatory submissions (INDs, NDAs, BLAs) or related submission-driven deliverables.Mastery of AMA style and familiarity with regulatory writing conventions and terminology.Rigorous editorial attention to detail and accuracy in scientific and medical content.Working knowledge of regulatory submission document structures and eCTD formatting expectations.Ability to work independently, meet deadlines, and adapt to changing priorities across concurrent projects.Strong communication skills and the ability to provide precise editorial feedback to technical and scientific contributors.
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