Job Title: Associate Director Principal Medical Writer
Location : USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings
About the Job
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?
Main Responsibilities:
Document Development
Create high-quality regulatory-compliant clinical documents supporting product life cycle
Ensure timely delivery while maintaining compliance with standards
Innovation
Lead implementation of new digital technologies and AI solutions
Drive process improvements for efficiency gains
Regulatory Expertise
Prepare registration dossiers and Health Authority responses
Monitor and implement regulatory documentation requirements
Project Management
Lead cross-functional initiatives as Subject Matter Expert
Drive change management within writing teams
Communication
Update relevant stakeholders on project progress and needs
Maintain accurate information in planning, tracking, and reporting toolsEnsure consistent communication across ClinDoc functions
Coordination
Mentor junior writers and review contract work
Quality & Training
Develop training programs and documentation standards
Build effective relationships with stakeholders and partners…
About You
Core Experience :
Six+ years as medical writer or equivalent specialist role
Proven track record leading multiple clinical documentation projects
Expert in clinical documentation preparation
Clinical Development Knowledge:
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
Professional Attributes:
Strong attention to detail and deadline management
Excellent organizational and follow-up abilities
Proven ability to work independently and in global teams
Technical skills :
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.
Why Choose Us?
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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