Director, Medical Writing

Accountabilities

• Lead the preparation, authoring, editing, and review of a broad range of clinical and regulatory documents, including study protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and submission materials.
• Collaborate with cross-functional stakeholders across clinical development, operations, pharmacology, research, biomarkers, medical affairs, and program management to ensure aligned, scientifically accurate, and regulatory-compliant documentation.
• Drive strategic document planning by ensuring consistent messaging across regulatory submissions and facilitating efficient document development throughout clinical programs.
• Manage document review cycles, coordinate comment resolution meetings, and ensure timely incorporation of stakeholder feedback while maintaining high quality standards.
• Contribute to project planning, regulatory submission readiness, and continuous improvement initiatives that enhance writing processes, templates, and document management practices.
• Ensure all deliverables comply with internal procedures, ICH/GCP guidelines, FDA and international regulatory requirements, and established quality standards.

Requirements

• Bachelor's degree in Life Sciences or a related discipline required; advanced degree preferred.
• Minimum of 5 years of medical writing experience within the pharmaceutical or biotechnology industry, with expertise in clinical and regulatory documentation.
• Proven experience authoring and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other regulatory documents.
• Strong understanding of FDA regulations, ICH guidelines, GCP standards, and global regulatory submission processes.
• Proficiency with Microsoft Office, Adobe Acrobat, and document management platforms such as SharePoint and Veeva.
• Excellent scientific writing, editing, communication, and project management skills, with the ability to manage multiple priorities under tight deadlines.
• Strong analytical thinking, attention to detail, and ability to synthesize complex scientific information into clear, compliant documentation.
• Demonstrated success collaborating across multidisciplinary teams while working independently with minimal supervision.

Benefits

• Competitive base salary ranging from $194,000 to $213,000 USD, based on experience, qualifications, and skills.
• Opportunity to contribute to innovative therapeutic development with meaningful patient impact.
• Collaborative, science-driven work environment with cross-functional exposure.
• Hybrid work flexibility.
• Professional growth opportunities within a rapidly advancing clinical development organization.
• Participation in projects spanning multiple clinical and regulatory programs.