Senior Manager, Medical Writing (Biopharmaceutical)

Location: Fully remote within the United States

Salary: $170,000–$190,000 USD annually, plus performance-based bonus and employee stock plan.

Company

hirify.global operates an AI-powered matching process and manages application screening on behalf of a partner company.

What you will do

• Author, edit, and finalize complex regulatory and clinical development documents.
• Lead FDA briefing documents, meeting requests, and materials for RMAT, Breakthrough Therapy Designation, and other regulatory engagements.
• Develop clinical protocol synopses and contribute to full clinical study protocols.
• Translate complex clinical and scientific data into clear, strategically positioned regulatory narratives.
• Coordinate cross-functional reviews, resolve comments, manage timelines, and deliver documents against aggressive deadlines.
• Identify document risks and gaps while providing strategic input on structure, messaging, and regulatory presentation.

Requirements

• 10+ years of medical writing experience in the biotechnology or pharmaceutical industry.
• Extensive experience independently authoring FDA regulatory documents and briefing packages.
• Experience supporting RMAT, Breakthrough Therapy Designation, or comparable FDA interactions.
• Strong experience developing clinical protocols and protocol synopses.
• Thorough knowledge of FDA regulations, ICH guidelines, and GCP requirements.
• Advanced degree in life sciences, pharmacy, medicine, or a related scientific discipline is preferred.

Nice to have

• Experience in autoimmune diseases such as Stiff Person Syndrome, Myasthenia Gravis, or Progressive Multiple Sclerosis.
• Experience with advanced cell therapy or biopharmaceutical development.
• Strong project management, scientific judgment, and cross-functional communication skills.

Culture & Benefits

• Fully remote work environment within the United States.
• Performance-based bonus and participation in an employee stock plan.
• Comprehensive employee benefits.
• Collaborative, cross-functional environment spanning clinical development, regulatory strategy, and advanced therapeutic programs.
• Opportunity to support regulatory milestones and novel treatments for significant unmet medical needs.

Hiring process

• Applications are reviewed through an AI-powered matching process.
• Shortlisted candidates are shared with the hiring company, which manages interviews, assessments, and final decisions.