Senior Manager Medical Writer, Clinical and Regulatory Medical Writing

Senior Manager Medical Writer, Clinical and Regulatory Medical Writing (Remote)

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA.

For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

About the Position

Reporting to the Senior Director, Clinical and Regulatory Medical Writing, the Manager/Senior Manager Medical Writer is a key member of Regulatory Affairs. You will plan, author, and finalize clinical and regulatory documents that support Cabaletta Bio’s development programs, ensuring they are clear, accurate, and strategically aligned. You will partner with cross-functional teams, including Clinical, Biostatistics, Quality, and Regulatory to ensure documents meet US, EU, and ICH standards.

Responsibilities:

• Author clinical and regulatory 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, keeping team members informed of expectations and milestones to ensure timely reviews and approvals.
• Perform quality control and editorial review to ensure documents meet standards for accuracy, consistency, structure, and clarity.
• Prepare documents for submission, including publishing readiness, quality checks, and finalization of supporting literature.
• Maintain high quality and efficiency in technical documentation that supports regulatory filings.
• Mentor junior medical writers and subject matter experts on technical writing skills and best practices.
• Participate in project team meetings and offer proactive solutions and advice.
• Complete training on company document management systems, and author or review departmental (clinical and regulatory) SOPs as needed.
• Perform other duties as assigned.

Qualifications:

• Bachelors or masters degree in biological sciences; with 6 years’ experience or Ph.D. and 2 years’ experience in a technical writing capacity.
• Familiarity with the key requirements for regulatory submissions in ICH regions as stipulated in applicable regulations and guidelines for pharmaceuticals/biologics.
• Experience in reviewing and writing regulatory submission documents for global regulatory 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, the regulatory environment, and medical terminology.
• Confidence to present to management, peers, and scientific or business collaborators.
• Ability to support multiple projects and to prioritize work independently.
• Ability to comply with company and/or industry style guides and templates.
• Ability to guide and train others in the writing of technical documentation.
• Fluent with written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy.
• Advanced MS Skills in Word, Excel, and Adobe Pro.
• Strong team orientation and passion for continuous self-development.
• Experience in the biotech industry or in a startup industrial setting is preferred.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.