Remote Medical Writer & Quality Control Manager

Cabaletta Bio

All (MO)

On-site

USD 120,000 - 180,000

Full time

14 days+

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Benefits offered by this job

Competitive benefits

PTO and stock options

Job summary

Cabaletta Bio is seeking a Manager, Medical Writer and Quality Control Specialist for remote work to support regulatory affairs and clinical development. This role partners with clinical and regulatory teams to produce high-quality documentation for regulators, editors, and trial sites.

The position requires expertise in regulatory submissions, strong writing skills, and a background in biological sciences, with leadership to train others and ensure compliance with US, EU and ICH guidelines.

Qualifications

Bachelor’s or Master’s in biological sciences or PhD with relevant experience.
Experience writing regulatory submission documents for global filings.
Ability to analyze complex data and present clearly.
Knowledge of regulatory environments and drug/biologics development.
Excellent attention to detail and scientific accuracy.

Responsibilities

Assist with clinical documentation (protocols, ICFs) and regulatory designations.
Manage document preparation timelines and communicate expectations.
Review and edit documents for accuracy and publishing readiness.
Support regulatory submissions and communications with CROs and sites.
Train others in technical writing best practices and templates.
Collaborate with clinical, regulatory, and translational teams.