Director, Medical & Regulatory Writing

Xencor; San Diego (CA); Hybrid; USD 176,000 - 205,000; Full time

Benefits offered by this job

401k match

Healthcare coverage

ESPP

Annual bonus

Equity grant

Job summary

Xencor, a clinical-stage biopharmaceutical company with offices in Pasadena and San Diego, seeks an Associate Director of Medical & Regulatory Writing. This role leads cross-functional teams to author, edit, and finalize submission-ready documents across protocols, CSRs, and regulatory briefs.

The ideal candidate has 10+ years in medical/regulatory writing, strong leadership, and expertise in SharePoint and Veeva RIM. Occasional travel between Pasadena and San Diego is expected.

Qualifications

• Bachelor's degree in life science or writing discipline; MS/PhD preferred.
• Minimum 10 years of medical/regulatory writing experience in pharma/biotech.
• Experience leading major regulatory documents or submission components and oversight of writing resources.

Responsibilities

• Prepare, review, and edit clinical and regulatory documents such as protocols, Investigator’s Brochures, Clinical Study Reports, and regulatory briefing documents.
• Develop and maintain document templates, style guides, and SOPs to ensure consistency and quality.
• Represent Medical and Regulatory Writing in team meetings and coordinate with vendors to meet milestones.
• Manage timelines, communicate deliverables, negotiate timelines, and ensure regulatory compliance.

Skills

Medical writing

Regulatory writing

Project management

Cross-functional collaboration

Leadership

Veeva RIM

SharePoint

Microsoft Word

Education

Bachelor's degree in life science or writing

Master's degree or PhD preferred

Tools

SharePoint

Veeva RIM

Microsoft Word

PowerPoint

Excel

Job description

Xencor, a clinical-stage biopharmaceutical company with offices in Pasadena and San Diego, seeks an Associate Director of Medical & Regulatory Writing. This role leads cross-functional teams to author, edit, and finalize submission-ready documents across protocols, CSRs, and regulatory briefs.

The ideal candidate has 10+ years in medical/regulatory writing, strong leadership, and expertise in SharePoint and Veeva RIM. Occasional travel between Pasadena and San Diego is expected.