Principal Clinical Medical Writer (Clinical Research)

Location: Working from home; hirify.global locations are in San Rafael and Novato, California, United States.

Company

hirify.global is a rare disease biotechnology company developing therapies for genetically defined conditions.

What you will do

• Provide functional oversight for medical writing staff and clinical medical writing requirements across development programs.
• Draft and edit protocols, protocol amendments, informed consent forms, clinical study reports, investigator brochures, and periodic safety reports.
• Prepare and support regulatory documents, including briefing books, IND/NDA materials, CTD Modules 2 and 5, and integrated safety and efficacy summaries.
• Plan timelines, resources, meetings, document reviews, and comment adjudication for multiple projects.
• Represent Clinical Medical Writing in study, development, and cross-functional team meetings.
• Develop and review medical writing processes, templates, and other regulatory and study materials.

Requirements

• Advanced understanding of drug development, clinical research, biostatistics, study conduct, data collection, database management, and data integration.
• Applied experience with protocol design, clinical study results reporting, integrated results reporting, and clinical study documentation.
• Experience writing, reviewing, or editing protocols, clinical study reports, INDs, BLA/NDAs, periodic safety documents, and regulatory briefing books.
• Knowledge of eCTD IND/NDA submissions, including Modules 2, 3, 4, and 5, ISS, and ISE.
• Ability to manage multiple documentation projects, shifting priorities, timelines, resources, and cross-functional reviews.
• Master's degree or higher preferred, preferably in a scientific discipline.

Nice to have

• Prior management experience leading a medical writing team or department.
• Medical writing or life sciences certification, such as an EMWA or AMWA certificate, Editor in Life Sciences certificate, or relevant DIA training.

Culture & Benefits

• Full-time employment within the Development Sciences organization.
• Work supporting therapies for rare genetic conditions and patients with significant unmet needs.
• Collaboration across global, cross-functional teams in clinical development and regulatory functions.
• Commitment to environmental protection, injury prevention, and continual improvement of EHS practices.