Associate Director Principal Medical Writer

Associate Director Principal Medical Writer at Sanofi summary:
The Associate Director Principal Medical Writer leads the creation and management of high-quality regulatory-compliant clinical documentation supporting drug development. This role involves implementing innovative digital technologies, managing cross-functional projects, and mentoring junior writers to ensure compliance and efficiency. The position requires deep expertise in clinical development processes, regulatory requirements, and document management systems.

Job Title:

Principal Medical Writer Associate Director

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 tools

Ensure consistent communication across Clin Doc 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…