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Technical Writer, Regulatory 

Philadelphia, PA

About the Position

The Regulatory Technical Writer will report to the Vice President, Regulatory be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators). The technical writer works with Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements.

Responsibilities Include

Maintains consistent high quality and efficiency in the generation of technical documentation to support regulatory filings

Assists with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and orphan drug applications for cell and gene therapy programs

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.

Works with technical 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

Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones, and document deliverables.

Ensures documents are finalized for submission including publishing readiness, quality checks and finalization of all supporting literature

Trains on company document management systems, authors and/or reviews departmental (clinical and regulatory) SOPs as needed

Performs other activities as assigned

Required Qualifications

  • Degree in Biological Sciences; BS or MS with 10 years’ experience or Ph.D. and 5 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
  • 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
  • Confidence to present to management, peers, and scientific or business collaborators
  • Strong written and verbal communication skills. Fluent written English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy
  • Advanced MS Skills in Word, Excel, and Adobe Pro

How to Apply

Please email careers@cabalettabio.com directly to submit an application.

Please include your CV along with the title of the position you are applying for.

Benefits

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

Equal Opportunity Employer

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.