Manager, Medical Writer and Quality Control

requirements.

Responsibilities: Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and regulatory designations (e.g. orphan drug applications, fast track, RMAT) for cell and gene therapy programs Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables. Reviews and edits documents including those authored by others Ensures documents are finalized for submission including publishing readiness, quality checks and finalization of all supporting literature Supports clinical trial readiness by working with clinical operations and CROs as needed for generation/review/editing of clinical study documentation including IRB/IBC communications/responses, study manuals, etc. Maintains consistent high quality and efficiency in the generation of technical documentation to support regulatory filings Works with clinical and translational teams to convert technical study data and results into reports in support of regulatory submissions. Provides training and mentoring to subject matter experts on technical writing skills and best practices Reviews and edits documents including those authored by others both internally and externally Is a collaborative team player participating in both internal and external project team meetings as needed, and offers proactive solutions and advice to team members Trains on company document management systems, authors and/or reviews departmental (clinical and regulatory) SOPs as needed Performs other activities 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. Apply for this job First name Last name Email address Location Phone number Resume Attach resume Attach another file Attach file Add another What are your salary

requirements? Are you authorized to work in the United States? Yes No Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? Yes No Linkedin url Should be {http://www.linkedin.com/pub/[member-name/]x/y/z} or {http://www.linkedin.com/in/string} © 2014-2026 TriNet Group, Inc. All rights reserved. Privacy Policy

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