Senior Medical Writing Lead for Oncology Submissions

Zentalis Pharmaceuticals; San Diego (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

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

Requirements include a PhD preferred, 5–8 years sponsor-level experience, and strong knowledge of NDA/eCTD modules. Collaboration across cross-functional teams is essential to deliver high-quality, inspection-ready documents on time.

Qualifications

• Advanced degree in life sciences with PhD preferred.
• 5–8 years sponsor-level biotech/pharma clinical/regulatory medical writing experience.
• Experience in oncology-focused medical writing and regulatory submissions.
• Direct or supportive NDA experience including eCTD Module authoring (M2/M2.5).
• Strong analytical and communication skills with attention to detail.

Responsibilities

• Provide strategic and operational medical writing expertise for clinical/regulatory documents.
• Lead standardized document development processes and timelines.
• Author and/or lead end-to-end clinical and regulatory documents.
• Support health authority submissions and document templates/standards development.
• Manage contract medical writers and review external deliverables.
• Ensure inspection-readiness of medical writing activities.

Skills

Medical Writing

Regulatory Submissions

ECTD Module Authoring

Protocol Authoring

Clinical Data Interpretation

Document Development Processes

SOP Development

Safety And Efficacy Data Synthesis

Time Management

Scientific Methodology

Education

PhD in Life Sciences

Advanced degree in life sciences

Tools

Veeva Vault

Microsoft 365

Job description

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

Requirements include a PhD preferred, 5–8 years sponsor-level experience, and strong knowledge of NDA/eCTD modules. Collaboration across cross-functional teams is essential to deliver high-quality, inspection-ready documents on time.