[Hiring] Associate Director - Principal Medical Writer @(0207) Sanofi US Services Inc.
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Role Description
- This role involves shaping the future of medicine by accelerating drug discovery and development.
- Create high-quality regulatory-compliant clinical documents supporting product life cycle
- Ensure timely delivery while maintaining compliance with standards
- Lead implementation of new digital technologies and AI solutions
- Drive process improvements for efficiency gains
- Prepare registration dossiers and Health Authority responses
- Monitor and implement regulatory documentation requirements
- Lead cross-functional initiatives as Subject Matter Expert
- Drive change management within writing teams
- Update relevant stakeholders on project progress and needs
- Maintain accurate information in planning, tracking, and reporting tools
- Ensure consistent communication across ClinDoc functions
- Oversee writing activities across teams and vendors
- Mentor junior writers and review contract work
- Develop training programs and documentation standards
- Build effective relationships with stakeholders and partners
- Qualifications
- Six+ years as medical writer or equivalent specialist role
- Proven track record leading multiple clinical documentation projects
- Expert in clinical documentation preparation
- Demonstrated expertise in clinical development processes
- Strong understanding of clinical study methodology and basic statistics
- Knowledge of regulatory environment
- Proficient in document management systems and authoring platforms
- Strong attention to detail and deadline management
- Excellent organizational and follow-up abilities
- Proven ability to work independently and in global teams
- Expertise in electronic document management and Microsoft Office
- Proven experience in implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions
- Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified
- Proficient in written and spoken English
- Benefits
- Wide range of health and wellbeing benefits including high-quality healthcare
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
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