Remote Manager, Medical Writing & Quality Control

Valid8 Financial, Inc.; Kentucky; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Benefits

PTO

Stock options

Job summary

Cabaletta Bio is seeking a Manager, Medical Writer Quality Control Specialist, remote from the US with the regulatory affairs and clinical development teams. The role focuses on producing high-quality clinical documentation and ensuring regulatory compliance across ICH regions.

You will mentor teams and help prepare submissions for regulators, journals, and trial sites, contributing to advancing cell therapies for autoimmune diseases.

Qualifications

• Bachelor's or Master's in biological sciences with 6 years’ experience or Ph.D. with 2 years in technical writing.
• Familiarity with regulatory submission requirements in ICH regions for pharmaceuticals/biologics.
• Experience in writing regulatory submission documents for global filings (IMPD, INDs, MAAs, NDAs, BLAs).
• Ability to analyze, synthesize, and present complex information in well-constructed documents.
• Knowledge of drug/biologics development, clinical research, study design, and regulatory environment.

Responsibilities

• Write and generate clinical documentation (protocols, investigator brochures, informed consents) and regulatory designations (e.g., orphan drug, fast track, RMAT).
• Manage document preparation timelines and coordinate reviews to meet milestones.
• Review and edit documents authored by others to ensure quality and accuracy.
• Ensure documents are finalized for submission with publishing readiness and literature support.
• Support clinical trial readiness by working with clinical operations and CROs on study documentation.

Skills

Regulatory writing

Regulatory submissions

Clinical documentation

Cross-functional collaboration

Attention to detail

MS Office

Education

Bachelors in biological sciences

Masters in biological sciences

PhD in biological sciences

Tools

Word

Excel

Adobe Pro

Job description

Cabaletta Bio is seeking a Manager, Medical Writer Quality Control Specialist, remote from the US with the regulatory affairs and clinical development teams. The role focuses on producing high-quality clinical documentation and ensuring regulatory compliance across ICH regions.

You will mentor teams and help prepare submissions for regulators, journals, and trial sites, contributing to advancing cell therapies for autoimmune diseases.