Associate Director, Medical Writing

Role Summary

Associate Director, Medical Writing responsible for writing, reviewing, and approving clinical and regulatory documents, collaborating across functions for document development, managing timelines, and overseeing outsourced medical writing projects.

Responsibilities

• Write and oversee clinical protocols, clinical study reports, investigator‚Äôs brochures, annual reports, IND/NDAs/NDA summary sections, and other regulatory submission documents
• Drive the document writing, review, and approval process in a collaborative manner
• Develop and maintain integrated timelines for document generation according to regulatory requirements and company goals
• Coordinate and manage review cycles, triage comments, and lead discussions on document revision and finalization
• With Director support, manage complex, multi-document outsourced writing projects
• Serve as the program-level point person for medical writing guidance and problem resolution
• Solve problems with sound judgment and flexibility in a dynamic environment
• Provide input on processes, templates, and other business needs within medical writing
• Learn disease state and therapeutic paradigm to support the team and manage content and messaging across the program
• Other duties as assigned

Qualifications

• Bachelor‚Äôs degree required; advanced life sciences degree preferred
• Minimum of 8 years regulatory medical writing experience in biotech/pharmaceutical industry
• Experience with INDs/BLAs/NDAs/MAAs and understanding of CTD structure
• Extensive experience with clinical protocols and clinical study reports, including ICH appendices
• Experience with electronic document management systems for document generation, writing, review, and approval
• Knowledge of regulations relevant to medical writing
• Ability to manage multiple writing projects with overlapping timelines
• Clear, scientifically accurate writing tailored to the audience
• Ability to collaborate across scientific and operational functions
• Solid understanding of statistical analysis in clinical trials
• Working knowledge of GCP, GLP, GMP, ICH guidelines, and FDA/EMA guidance on submission elements
• Excellent written and verbal communication skills
• Strong project management skills and ability to meet timelines
• Fluent English communication skills, both written and verbal

Skills

• Technical writing for clinical and regulatory documents
• Cross-functional collaboration
• Project management
• Regulatory submission readiness
• Content strategy and messaging across programs

Education

• Bachelor‚Äôs degree required; advanced life sciences degree preferred

Additional Requirements

• Travel: Up to 5% of time
• Physical demands: Sedentary desk work with occasional lifting up to 25 lbs; laboratory environment experience may apply