Senior Medical Writer - Regulatory
Immix Biopharma (Nasdaq: IMMX), Los Angeles, CA, United States
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.
Draft, review, and finalize regulatory documents including Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), 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.
What We Look For
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.
#J-18808-Ljbffr
Draft, review, and finalize regulatory documents including Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), 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.
What We Look For
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.
#J-18808-Ljbffr