Senior Medical Writing Lead - Regulatory & Clinical (Remote)

Travere Therapeutics; Atlanta (GA); On-site; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is actively seeking a Senior Manager for Medical Writing. This role involves leading the creation and management of important regulatory documents while ensuring scientific accuracy and compliance. The candidate should possess a strong background in medical writing and regulatory submissions.

The position is partially remote and requires collaboration with cross-functional teams. A competitive compensation package and excellent benefits await the suitable candidate.

Qualifications

• 7+ years of experience in medical writing or regulatory writing.
• Demonstrated leadership in authoring clinical documents.
• Strong working knowledge of drug development processes.

Responsibilities

• Author and coordinate regulatory and clinical documents.
• Manage document development timelines and review cycles.
• Ensure compliance with FDA, EMA, and other regulations.

Skills

Expert scientific writing

Project management

Attention to detail

Communication skills

Knowledge of regulatory requirements

Education

Bachelor's degree in Life Sciences or related field

Advanced degree (MS, PharmD, PhD) preferred

Tools

Microsoft Office

Veeva platforms

Electronic document management systems

Job description

Travere Therapeutics is actively seeking a Senior Manager for Medical Writing. This role involves leading the creation and management of important regulatory documents while ensuring scientific accuracy and compliance. The candidate should possess a strong background in medical writing and regulatory submissions.

The position is partially remote and requires collaboration with cross-functional teams. A competitive compensation package and excellent benefits await the suitable candidate.