Senior Manager, Medical Writer – Clinical and Regulatory

🔥 7 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 11%

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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

• Plan, author, and finalize clinical and regulatory documents supporting Cabaletta Bio’s development programs • Author documents for cell and gene therapy programs, including INDs, Module 2 documents supporting BLAs, protocols and amendments, investigator brochures, and clinical study reports • Manage document timelines and review workflows in Veeva Vault • Keep team members informed of review expectations and milestones • Perform quality control and editorial review for accuracy, consistency, structure, and clarity • Prepare documents for submission, including publishing readiness, quality checks, and finalization of supporting literature • Maintain high-quality and efficient technical documentation supporting regulatory filings • Mentor junior medical writers and subject matter experts on technical writing skills and best practices • Participate in project team meetings and provide proactive solutions and advice • Complete training on company document management systems • Author or review clinical and regulatory departmental SOPs as needed • Report to the Senior Director, Clinical and Regulatory Medical Writing • Partner with Clinical, Biostatistics, Quality, and Regulatory teams to meet US, EU, and ICH standards

🎯 Requirements

• Bachelor’s or master’s degree in biological sciences with 6 years’ experience or Ph.D. with 2 years’ experience in a technical writing capacity • 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 IMPD, INDs, MAAs, NDAs, and BLAs is preferred • Ability to critically analyze, synthesize, and present complex information in well-constructed documents • Working knowledge of drug/biologics development, clinical research, study design, biostatistics, regulatory environment, 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/or industry style guides and templates • Ability to guide and train others in technical documentation writing • Fluent written and spoken English • 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 startup industrial setting is preferred

🏖️ Benefits

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