Lead Medical Writer – Regulatory Submissions

Kaztronix; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Kaztronix is seeking an Associate Director, Principal Medical Writer II to lead regulatory writing for global submissions, including IBs, CSR, and regulatory documents. You will provide strategic direction to cross-functional teams, ensure data is accurately presented, and deliver high‑quality documents with minimal oversight.

You will mentor junior writers, oversee multiple compounds, and drive process improvements while aligning with regulatory requirements and program goals.

Qualifications

• Bachelor's degree required; advanced degree preferred in a relevant field.
• Minimum 7 years of medical writing experience in biopharma/CRO settings.
• Strong ability to interpret clinical data and define data presentation for key messages.
• Excellent project management and cross-functional collaboration skills.
• Fluent written and verbal communication; regulatory knowledge in global contexts.
• Experience leading development, review, and approval of clinical documents.

Responsibilities

• Develop regulatory documents for global regulatory submissions per ICH guidelines.
• Lead, manage and coordinate internal and external medical writing activities.
• Participate in cross-functional meetings to align deliverables and timelines.
• Review protocols and statistical analysis plans for integrated documents.
• Drive process improvements and write standard operating procedures.
• Mentor junior medical writers and oversee multiple compounds' documentation.

Skills

Medical writing

Regulatory writing

Project management

Communication

Education

Bachelor's degree

Advanced degree (preferred)

Tools

MS Word

EDMS

Job description

Kaztronix is seeking an Associate Director, Principal Medical Writer II to lead regulatory writing for global submissions, including IBs, CSR, and regulatory documents. You will provide strategic direction to cross-functional teams, ensure data is accurately presented, and deliver high‑quality documents with minimal oversight.

You will mentor junior writers, oversee multiple compounds, and drive process improvements while aligning with regulatory requirements and program goals.