Oncology Regulatory Submissions Lead Medical Writer

Zentalis Pharmaceuticals; San Diego (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

Jobtailor in San Diego is seeking a Senior Medical Writer with an oncology focus to deliver strategic and operational medical writing for complex clinical and regulatory documents. You will lead authoring and end-to-end development for health authority submissions.

The role requires a PhD preferred, 5-8 years sponsor-level experience, and strong NDA/eCTD knowledge. Collaboration across cross-functional teams is essential to deliver inspection-ready documents on time.

Qualifications

• PhD preferred; experience in clinical/regulatory medical writing.
• 5-8 years sponsor-level experience in medical writing.
• Strong knowledge of NDA/eCTD modules.

Responsibilities

• Lead authoring and end-to-end development for health authority submissions.
• Provide strategic and operational medical writing across complex documents.
• Collaborate with cross-functional teams to ensure inspection-ready documents.

Skills

Strategic medical writing

Cross-functional collaboration

Education

PhD preferred

Tools

NDA/eCTD knowledge

Job description

Jobtailor in San Diego is seeking a Senior Medical Writer with an oncology focus to deliver strategic and operational medical writing for complex clinical and regulatory documents. You will lead authoring and end-to-end development for health authority submissions.

The role requires a PhD preferred, 5-8 years sponsor-level experience, and strong NDA/eCTD knowledge. Collaboration across cross-functional teams is essential to deliver inspection-ready documents on time.