[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
Apply Now
Apply Now
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
Apply Now
Apply Now