Job Title: Principal Medical Writer Associate DirectorLocation: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetingsAbout the JobAre 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<ul><li>Create high-quality regulatory-compliant clinical documents supporting product life cycle</li><li>Ensure timely delivery while maintaining compliance with standards</li></ul>Innovation<ul><li>Lead implementation of new digital technologies and AI solutions</li><li>Drive process improvements for efficiency gains</li></ul>Regulatory Expertise<ul><li>Prepare registration dossiers and Health Authority responses</li><li>Monitor and implement regulatory documentation requirements</li></ul>Project Management<ul><li>Lead cross-functional initiatives as Subject Matter Expert</li><li>Drive change management within writing teams</li></ul>Communication<ul><li>Update relevant stakeholders on project progress and needs</li><li>Maintain accurate information in planning, tracking, and reporting toolsEnsure consistent communication across ClinDoc functions</li></ul>Coordination<ul><li>Mentor junior writers and review contract work</li></ul>Quality &amp; Training<ul><li>Develop training programs and documentation standards</li><li>Build effective relationships with stakeholders and partners…</li></ul>About YouCore Experience:<ul><li>Six+ years as medical writer or equivalent specialist role</li><li>Proven track record leading multiple clinical documentation projects</li><li>Expert in clinical documentation preparation</li></ul>Clinical Development Knowledge:<ul><li>Demonstrated expertise in clinical development processes</li><li>Strong understanding of clinical study methodology and basic statistics</li><li>Knowledge of regulatory environment</li><li>Proficient in document management systems and authoring platforms</li></ul>Professional Attributes:<ul><li>Strong attention to detail and deadline management</li><li>Excellent organizational and follow-up abilities</li><li>Proven ability to work independently and in global teams</li></ul>Technical skills:<ul><li>Expertise in electronic document management and Microsoft Office</li><li>Proven experience in implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions.</li></ul>Why Choose Us?<ul><li>Bring the miracles of science to life alongside a supportive, future-focused team.</li><li>Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.</li><li>Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</li><li>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.</li></ul>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<h1>Pursue progress, discover extraordinary</h1>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 orientation, age, citizenship, marital status, ability or gender identity.Watch our <a href="https://www.youtube.com/watch?v=SkpDBZ-CJKw&amp;t=67s" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" target="_blank">sanofi.com</a>!US and Puerto Rico Residents OnlySanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.North America Applicants OnlyThe salary range for this position is:$147,000.00 - $212,333.33All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the <a target="_blank" href="https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi">LINK</a>.

Sanofi

Associate Director Principal Medical Writer

Sanofi

Similar Remote Jobs