Director, Medical Writing (Biotech)

Location: Waltham, Massachusetts, or remote within the United States

Salary: $190,000–$235,000 USD per year

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to improve function for people living with genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead the planning, authoring, review, and completion of clinical and regulatory documents for FDA and global health authority submissions.
• Author and edit protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials.
• Manage internal and external medical writing resources, including vendors, consultants, and cross-functional contributors.
• Partner with Clinical Development, Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Research, Preclinical, Translational Biomarkers, Program Management, and Medical Affairs.
• Ensure scientific accuracy, consistency, quality, and compliance with SOPs, ICH/GCP guidance, and regulatory requirements.
• Improve medical writing processes, templates, and best practices to increase operational efficiency.

Requirements

• Bachelor’s degree in life sciences or a related discipline; an advanced degree is preferred.
• 10+ years of medical writing experience in the pharmaceutical or biotechnology industry.
• Extensive experience preparing and reviewing clinical and regulatory documents, including protocols, clinical study reports, investigator brochures, and CTD modules.
• Strong knowledge of FDA and international regulations, ICH guidelines, CTD requirements, and documents supporting INDs, CTAs, annual reports, and related submissions.
• Ability to lead strategic discussions, synthesize complex clinical and scientific data, and align messaging across submissions.
• Proficiency with Microsoft Office, Adobe Acrobat, and shared document management systems such as SharePoint.

Culture & Benefits

• High degree of independence in a fast-paced, cross-functional environment.
• Collaboration across clinical, regulatory, research, medical affairs, and program management functions.
• Remote work is available for the role.