Director, Medical Writing (Biotech)

Location: Remote within the United States, with periodic travel to hirify.global offices in Boston, Massachusetts, for in-person collaboration and business operations.

Salary: $199,000–$258,000 USD annually, with potential discretionary annual bonus and long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Author, coordinate, and review clinical and regulatory documents, including protocols, CSRs, IBs, SAPs, ICFs, INDs, CTAs, and selected BLA/NDA components.
• Define submission narratives and key messages while maintaining scientific consistency across CTD modules.
• Plan integrated deliverables and review cycles across Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs.
• Manage and develop medical writing staff and contract writers.
• Select and oversee medical writing vendors, including deliverables, quality, performance, budgets, and capacity planning.
• Establish SOPs, style guides, templates, training, and quality-control processes for regulatory document authoring and approval.

Requirements

• Advanced degree at the PhD, PharmD, or master’s level in life sciences, pharmacology, biomedical sciences, or a related discipline.
• 10+ years of medical writing experience in the pharmaceutical or biotechnology industry.
• Extensive experience with ICH CTD regulatory submissions, including CSRs, ISS/ISE, IBs, and IND/CTA packages.
• Knowledge of FDA and EMA requirements, ICH E3, E6, E8, M4, and pharmacovigilance documentation standards.
• Experience developing Medical Writing SOPs, style guides, templates, publication plans, and regulatory document processes.
• Experience with document management and electronic submission platforms such as Veeva Vault or equivalent, plus the ability to lead cross-functional teams and communicate with senior stakeholders.

Nice to have

• Scientific expertise in immunology, inflammation, or autoimmune disease.
• Experience with AI-assisted authoring and review tools in regulated clinical and regulatory environments.
• Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech company.

Culture & Benefits

• Remote work arrangement with periodic in-person collaboration at company offices.
• Flexible work arrangements or hybrid scheduling.
• Health and wellness coverage, varying by country and eligibility.
• Paid time off, public holidays, and additional leave in accordance with local requirements.
• Inclusive environment focused on accountability, continuous learning, and collaboration.