Associate Director Principal Medical Writer

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* 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
** 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.
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* 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.
* 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.#GD-SA   #LI-SA      #LI-Onsite#vhd# Pursue
* progress*, discover
* extraordinary*Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual…