Quality Control Medical Writing

Serene Healthcare Staffing; San Francisco (CA); On-site; USD 110,000 - 180,000; Full time

Job summary

Zohorecruit in San Francisco, CA, seeks a Medical Writer to help shape AI-powered regulatory documentation, bridging medical writing with regulatory product development.

You will evaluate AI-generated output, refine QC heuristics for engineers, and ensure compliance with FDA, EMA, and ICH guidelines in an in-office SF role.

Qualifications

• 3+ years of US-based experience in US regulatory medical writing.
• Regulatory documentation and CTD exposure.
• Ability to extract rules/logic for technical teams.
• Strong QC capabilities and attention to detail.

Responsibilities

• Help design AI systems that write regulatory documents.
• Deconstruct authoring/review/QC heuristics for engineers.
• Evaluate AI-generated content quality and identify edge cases.
• Bridge medical writing expertise with technical product development.

Skills

US-based experience

Medical writing

Regulatory affairs

Edge case analysis

QC capabilities

Tools

XML/JSON familiarity

Life sciences software

Job description

San Francisco, United States

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• State/Province California
• Country United States

Job Description

• Helping design AI systems that write regulatory documents.
  
• Deconstructing authoring/review/QC heuristics for engineers.
  
• Evaluating AI-generated content quality and identifying edge cases.
  
• Bridging the gap between domain expertise (medical writing) and technical product development.
  

Requirements

Must Have Skills for Role:

• candidates MUST have at least 3 years of US-based experience in the US.
  
• Additionally, if applicable, please explicitly state that the candidate is open to immediate relocation since these are IN-OFFICE in SF positions.
  

3+ years of medical writing experience in regulatory affairs.

Direct experience with CTD documents (non-clinical and CMC).

Knowledge of FDA, EMA, and ICH guidelines.

Ability to extract and document rules/logic for technical teams.

Strong QC capabilities.

Nice to Have Skills for Role:

Familiarity with structured content formats like XML or JSON.

Experience working with life sciences software tools.