Associate Director, Medical Writing (Clinical and Regulatory) (Biotech)

Location: United States — remote, officially documented as full-time work from home, with occasional travel to hirify.global offices or other locations and several trips per year.

Annual salary: $188,900–$233,300 USD, plus eligibility for an annual bonus and equity incentives.

Company

hirify.global is a biopharmaceutical company developing innovative medicines for patients with rare diseases.

What you will do

• Draft, edit, review, and coordinate clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA summaries, response documents, and briefing books.
• Manage document development from templates and first drafts through review, quality control, approval, publishing, and archiving.
• Represent Clinical Regulatory Writing on cross-functional project teams, supporting accurate deliverables and negotiating timelines.
• Implement clinical transparency and disclosure practices, including Policy 70 and ClinicalTrials.gov requirements.
• Develop medical writing strategies, processes, and standards with department colleagues.
• Distill clinical and scientific data into clear tables and graphical displays while ensuring compliance with ICH, GCP, SOP, and health authority guidance.

Requirements

• BS, MS, or doctorate in a scientific or medical field.
• Six or more years of experience in the biotechnology or pharmaceutical industry, including medical writing, editing, and clinical development.
• Experience writing protocols, investigator brochures, and clinical study reports; experience with at least one eCTD/NDA submission is advantageous.
• Strong leadership, planning, project management, organization, communication, and partnership-building skills.
• Ability to manage multiple high-priority projects, work autonomously with minimal supervision, and maintain high quality and ethical standards.
• Excellent computer skills, including Microsoft Office, PowerPoint, Adobe Illustrator, figures, and graphic design; willingness to travel several times a year.

Nice to have

• Experience with rare diseases and/or gene therapy.
• Experience with Microsoft Project and Visio.

Culture & Benefits

• Supportive and inclusive environment focused on learning and professional growth.
• Generous vacation time and company-observed public holidays.
• Volunteer days, employee wellbeing benefits, and fitness reimbursement.
• Long-term incentive and employee stock purchase plans or equivalent offerings.
• Tuition sponsorship and professional development plans.