Company
Biotech
DirectorofMedicalWriting
“Director of Medical Writing. Skills: Medical writing, Regulatory documentation, People leadership. Lead and/or author regulatory and clinical documentation. Ensure consistency, quality, and compliance”
What You'll Achieve.
Ensure submission readiness; Maintain documentation quality; Maintain documentation consistency; Maintain documentation compliance
Industry & Context.
Interpret complex scientific data
What They're Looking For.
Must Have
Bachelor's degree in scientific or clinical discipline, 7+ years sponsor-side pharmaceutical or biotech medical writing experience, Proven experience authoring eCTD Module 2 and Module 5 documents, Experience managing or mentoring medical writers, Understanding of clinical development, Ability to interpret complex scientific data, Excellent written and verbal communication skills, Attention to detail and quality standards, Organizational and project management skills
Nice to Have
Advanced degree (PhD preferred)
What You'll Do.
Lead and/or author regulatory and clinical documentation
Manage and mentor medical writers
Ensure alignment with project goals
Author and/or oversee development of key regulatory documents
Ensure documentation meets internal standards
Ensure documentation meets regulatory requirements
Ensure documentation meets submission readiness expectations
Collaborate with cross-functional teams
Collaborate with subject matter experts
well-structured scientific content
Drive standardization of medical writing practices
Support departmental strategy development
Support resource planning
Support continuous improvement initiatives
How You'll Work.
Team & Collaboration
Cross-functional teams; Subject matter experts
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management
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