Director, Medical Writing (Biotech)

Location: Remote within the United States or Waltham, Massachusetts

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

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to address 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.
• Manage internal and external medical writing resources, including vendors, consultants, and cross-functional contributors.
• Author and edit protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials.
• Review contributed content for scientific accuracy, consistency, quality, and compliance with company and regulatory standards.
• Support cross-functional project planning and working groups throughout document development, review, approval, and finalization.
• Improve medical writing processes, templates, and best practices to increase quality, consistency, and 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.
• Significant experience preparing and reviewing clinical and regulatory documents, including protocols, clinical study reports, investigator brochures, and CTD modules.
• Strong understanding of FDA and international regulations, ICH guidelines, GCP, CTD requirements, and submission processes for INDs, CTAs, annual reports, and related documents.
• Ability to develop medical writing strategies, lead strategic discussions, synthesize complex scientific data, and align messaging across submissions.
• Strong organization, communication, collaboration, problem-solving, and attention-to-detail skills, with proficiency in Microsoft Office, Adobe Acrobat, and document management systems such as SharePoint.

Culture & Benefits

• Work independently while collaborating with Clinical Development, Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Research, Preclinical, Translational Biomarkers, Program Management, and Medical Affairs.
• Operate in a fast-paced, cross-functional biotechnology environment focused on improving outcomes for people with neuromuscular diseases.
• Support document development aligned with company priorities, SOPs, ICH/GCP guidance, and applicable regulatory requirements.