Associate Director, Medical Writing
Core
Plan, develop, and deliver high-quality clinical and regulatory documents (protocols, study reports, registration dossiers) for gene therapy programs.
Role type
Associate Director, Medical Writing
Builds
Clinical protocols, clinical study reports, Investigator's brochures, Module 2 summaries, regulatory submissions
Domain
Biopharmaceuticals / Gene Therapy / Clinical Development
Required skills
Medical writing, regulatory document preparation, GCP/ICH/eCTD compliance, drug development process knowledge, NDA/BLA preparation, project management, SOP creation, cross-functional collaboration
Preferred skills
Life sciences degree, experience with electronic document systems, metrics analysis, mentoring
Technologies
MS Office Suite, electronic document systems, TMF systems
Responsibilities
Plan, prepare, write, edit, format, and finalize clinical and regulatory documents; Provide product and platform writing and strategy support to cross-functional teams; Ensure adherence to MW processes and compliance with global regulations; Create and maintain SOP and MW governance documents; Lead efforts to identify and solve compliance or efficiency gaps; Support development, onboarding, and training for direct reports and MW team
Seniority
Senior, hands-on IC with leadership responsibilities
