Senior Medical Writer - Pharmaceutical & Regulatory

About the role

The Regulatory Medical Writer will play a critical role in the clinical development department, responsible for preparing, reviewing, and editing regulatory documents required for submission to the U.S. Food and Drug Administration (FDA) and other regulatory bodies. This position ensures all documents comply with FDA guidelines, accurately reflect clinical data, and support the advancement of biopharmaceutical products through various stages of clinical trials.

Responsibilities

• Draft, review, and finalize regulatory documents including Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), study protocols, clinical study reports, and briefing documents.
• Ensure all documents adhere to regulatory regulations, guidance, and formatting requirements.
• Collaborate with clinical, regulatory, and scientific teams to gather and interpret data for regulatory submissions.
• Maintain up-to-date knowledge of FDA regulatory requirements and industry best practices.
• Participate in project meetings and provide expert advice on regulatory writing strategies.
• Manage timelines and deliverables for multiple writing projects to ensure timely submission.

Requirements

• Bachelor’s degree in life sciences, medical, or related field; advanced degree preferred.
• Minimum 5 years of experience in regulatory medical writing within the biopharma industry.
• Strong understanding of FDA regulatory processes and clinical trial documentation.
• Excellent written and verbal communication skills.
• Proven ability to work collaboratively in a cross-functional team environment.
• Detail-oriented with strong organizational and project management skills.
• Experience with electronic submission formats and regulatory publishing tools.
• Familiarity with other global regulatory agencies is a plus.
• Ability to interpret complex clinical data and present it clearly in regulatory documents.

About Immix Biopharma

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is the global leader in relapsed/refractory AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system produces toxic light chains, clogging the heart, kidney, and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by the FDA and in the EU by the EMA.