Senior Medical Writer, Remote Nonclinical Focus

Veristat; United States; Hybrid; USD 132,000 - 151,000; Full time

Job summary

Veristat seeks a Principal Regulatory Medical Writer to independently plan and prepare regulatory documents supporting all product development phases. You will organize, analyze, interpret, and present scientific data according to ICH guidelines and company standards, collaborating with internal teams and external production partners.

The role emphasizes leadership of submission-level sections, quality document finalization, and maintaining timelines within budget while coaching others on best

Qualifications

• Bachelor’s degree required; MS or PhD preferred.
• 7+ years regulatory writing or equivalent nonclinical CTD work.
• Ability to lead internal teams and anticipate regulatory writing impacts.
• Experience developing submission-level documents.

Responsibilities

• Plan and prepare regulatory documents across product development.
• Organize, analyze, interpret and present scientific data per ICH guidelines.
• Collaborate with cross-functional teams and external vendors.

Skills

Regulatory writing

Project leadership

Data synthesis

Client relationships

Communication coaching

Education

Bachelor's degree

MS or PhD preferred

Tools

Microsoft Word

Document management systems

Job description

Veristat seeks a Principal Regulatory Medical Writer to independently plan and prepare regulatory documents supporting all product development phases. You will organize, analyze, interpret, and present scientific data according to ICH guidelines and company standards, collaborating with internal teams and external production partners.

The role emphasizes leadership of submission-level sections, quality document finalization, and maintaining timelines within budget while coaching others on best