[Hiring] Associate Director - Principal Medical Writer @(0207) Sanofi US Services Inc.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. 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 tot his job Apply To this Job