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Director / Senior Director, Medical Writing
Posted 11 days agoViewed
💎 Seniority level: Senior, 12+ years
🔍 Industry: Biotechnology
🏢 Company: Dianthus Therapeutics👥 11-50💰 $230,000,000 Post-IPO Equity about 1 year agoBiotechnologyBiopharmaHealth Care
⏳ Experience: 12+ years
Requirements:
- Advanced degree in life sciences preferred; minimum BS/BA required
- 12+ years’ experience in a medical writing capacity within drug development
- Working knowledge of clinical research, study design, pharmacology, biostatistics, regulatory requirements, and medical terminology
- Experience leading medical writing teams responsible for global marketing authorization applications
- Exceptional information gathering and conceptual skills
- Ability to analyze, interpret, and summarize highly complex data
- Outstanding project management and organizational skills
- Adept at facilitating the open exchange of ideas and opinions to achieve consensus
- Ability to work effectively under pressure and meet time-sensitive deadlines
- Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers
- Proficient in the use of MS Word, Endnote, Adobe Acrobat, PleaseReview, and structured document templates
- Experience with inspection readiness activities and representing MW during GCP inspections
- Proactive team player, collaborative, resourceful, and flexible
Responsibilities:
- Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents
- Lead writing strategy, drive document content and organization, establish and manage timelines, and ensure adherence to regulations and guidelines
- Oversee document review and comment resolution process
- Participate in Rapid Response Teams to support timely delivery of responses to Health Authority Information Requests
- Generate and maintain templates, style guides, and quality control checklists that drive consistency
- Plan strategically, anticipate problems, and recommend process improvements to address current and future needs
- Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables using a mix of internal and external medical writers
- Serve on cross-functional teams working on SOPs, process improvements, and integration of new tools and technologies
- Coach, develop, and support writers (internal and external)
- Act as subject matter expert for development of data transparency deliverables
- Oversee medical writing resourcing to support publication plans and ensure consistency of messaging with clinical and regulatory submissions
- Ability to travel 10-15% for functional team meetings and company events
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