Associate Director, Medical Writing

Travere Therapeutics

Associate Director, Medical Writing at Travere Therapeutics overseeing regulatory submissions and ensuring compliance for rare disease therapies. Leading document strategy and project management in a collaborative team.

Posted 6/24/2026full-timeSan Diego • California • 🇺🇸 United StatesSenior💰 $150,000 - $195,000 per yearWebsite

About the role

Key responsibilities & impact

Responsible for oversight and authoring of regulatory submissions and other regulatory, clinical, and safety documents
Contributing to the strategy of document development and project management during drafting and approval cycles
Ensure documents are compliant and completed on-time and on-budget
Support projects across all phases of clinical development and post-marketing life cycle management
Serve as the medical writing lead for regulatory submissions and provide strategic guidance to study teams
Lead and manage comment resolution meetings
Mentor junior writers as applicable

Requirements

What you’ll need

Master’s Degree in Life Science or related disciplines required; PhD or PharmD preferred
Minimum 6 years of progressively responsible medical writing experience in a biopharmaceutical/industry environment or 8+ years at a Contract Research Organization (CRO) or related environment
Strong scientific writing, editing, and communication skills
Demonstrated experience contributing to development of document strategy and authoring clinical, regulatory, and scientific documents
Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements
Proficiency with Microsoft Office applications, Veeva platforms, and electronic document management systems
Strong project management and organizational skills
Ability to work independently while collaborating effectively with cross-functional teams
Experience mentoring writers preferred by not required.

Benefits

Comp & perks

premium health
financial
work-life and well-being offerings for eligible employees and dependents
wellness and employee support programs
life insurance
disability
retirement plans with employer match
generous paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingregulatory submissionsclinical document developmentscientific writingeditingproject managementdocument strategyauthoring clinical documentsauthoring regulatory documentsauthoring scientific documents

Soft Skills

communication skillsorganizational skillsmentoringcollaborationleadership

Certifications

Master’s Degree in Life SciencePhDPharmD