Senior Regulatory Medical Writer - Pharma Submissions

Immix Biopharma (Nasdaq: IMMX); Los Angeles (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Immix Biopharma, Inc. is seeking a Senior Medical Writer to prepare, review, and edit regulatory documents for FDA submissions.

You will work with clinical, regulatory, and scientific teams to ensure accuracy, compliance, and timely delivery across IND, NDA, and BLA programs. The role requires 5+ years in regulatory medical writing, a life sciences degree (advanced degree preferred), and strong communication skills.

Qualifications

• Bachelor’s degree in life sciences; advanced degree preferred.
• Minimum 5 years of regulatory medical writing experience.
• Strong knowledge of FDA regulatory processes and clinical trial documentation.
• Excellent written and verbal communication; cross-functional teamwork.

Responsibilities

• Draft, review, and finalize regulatory documents including INDs, NDAs, BLAs, protocols, CSRs, and briefing documents.
• Ensure documents adhere to regulatory regulations, guidance, and formatting.
• Collaborate with clinical, regulatory, and scientific teams to interpret data for submissions.
• Maintain up-to-date knowledge of FDA regulatory requirements and industry best practices.
• Participate in project meetings and provide regulatory writing strategy guidance.
• Manage timelines and deliverables for multiple writing projects to ensure timely submission.

Skills

Excellent communication

Cross-functional collaboration

Regulatory writing knowledge

Attention to detail

Education

Bachelor’s degree in life sciences or related field; advanced degree preferred

Tools

Regulatory publishing tools

Electronic submission formats

Job description

Immix Biopharma, Inc. is seeking a Senior Medical Writer to prepare, review, and edit regulatory documents for FDA submissions.

You will work with clinical, regulatory, and scientific teams to ensure accuracy, compliance, and timely delivery across IND, NDA, and BLA programs. The role requires 5+ years in regulatory medical writing, a life sciences degree (advanced degree preferred), and strong communication skills.