Manager, Medical Writing – Quality Control

Job not on LinkedIn

🔥 1 hour ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✏️ Content Writer

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Cabaletta Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies to treat autoimmune diseases. Using its CABA® (Cabaletta Approach to B cell Ablation) platform, the company is advancing rese-cel, a fully human CD19 CAR T cell candidate with a 4-1BB co-stimulatory domain, in multiple RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. Cabaletta aims to deliver deep, durable, potentially curative responses by transiently eliminating B cells to reset immune tolerance, and emphasizes patient-centered development and broad indication expansion across rheumatology, dermatology, and neurology.

📋 Description

• Assist with writing and generating clinical documentation, including protocols, investigator brochures, and informed consents • Prepare regulatory designations such as orphan drug applications, fast track, and RMAT applications for cell and gene therapy programs • Manage document preparation timelines and communicate expectations, reviews, milestones, and deliverables • Review and edit internally and externally authored documents • Ensure submission documents are publication-ready, quality-checked, finalized, and supported by complete literature • Support clinical trial readiness with clinical operations and CROs, including IRB/IBC communications, study manuals, and related documentation • Maintain quality and efficiency of technical documentation for regulatory filings • Convert technical study data and results into reports supporting regulatory submissions • Train and mentor subject matter experts on technical writing skills and best practices • Participate in internal and external project team meetings and provide proactive solutions and advice • Train on company document management systems and author or review clinical and regulatory SOPs • Perform other assigned activities

🎯 Requirements

• Bachelor’s or master’s degree in biological sciences with 6 years’ experience in a technical writing capacity, or Ph.D. with 2 years’ experience • Familiarity with key requirements for regulatory submissions in ICH regions and applicable pharmaceutical/biologics regulations and guidelines • Experience reviewing and writing regulatory submission documents for global filings such as IMPDs, INDs, MAAs, NDAs, and BLAs is preferred • Ability to critically analyze, synthesize, and present complex information in well-constructed documents • Working knowledge of drug and biologics development, clinical research, study design, biostatistics, regulatory environments, and medical terminology • Confidence presenting to management, peers, and scientific or business collaborators • Ability to support multiple projects and prioritize work independently • Ability to comply with company and industry style guides and templates • Ability to guide and train others in technical documentation writing • Fluency in written and spoken English, with excellent attention to detail in consistency, grammar, syntax, and scientific accuracy • Advanced skills in Microsoft Word, Excel, and Adobe Pro • Experience in the biotech industry or a startup industrial setting is preferred • Strong team orientation and passion for continuous self-development

🏖️ Benefits

• Competitive benefits • PTO • Stock option plans • Commitment to employee well-being and continuous growth • Training and mentoring opportunities