Associate Director Principal Medical Writer

Sanofi • Morristown, NJ

68d • Remote

About The Position

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Global Medical writing and Document management serves to generate timely, high quality, cost effective and regulatory compliant documents. Our mission is to synergize and harness evolving technologies pushing the edge of regulatory writing. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Requirements

• 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.

Responsibilities

• 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 toolsEnsure consistent communication across ClinDoc functions
• Mentor junior writers and review contract work
• Develop training programs and documentation standards
• Build effective relationships with stakeholders and partners…

Benefits

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees