Associate Director - Principal Medical Writer (Hiring ...

Job title: Associate Director - Principal Medical WriterLocation: USA, Remote. Proximity to Cambridge/Boston, MA or Morristown, NJ is highly desirable for attending occasional team meetings.Grade: L3Hiring Manager: MW Head MTA1Job type: PermanentAbout 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.Our Team: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 peoples lives. Were 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 DevelopmentCreate high-quality regulatory-compliant clinical documents supporting product life cycleEnsure timely delivery while maintaining compliance with standardsInnovationLead implementation of new digital technologies and AI solutionsDrive process improvements for efficiency gainsRegulatory ExpertisePrepare registration dossiers and Health Authority responsesMonitor and implement regulatory documentation requirementsProject ManagementLead cross-functional initiatives as Subject Matter ExpertDrive change management within writing teamsCommunicationUpdate relevant stakeholders on project progress and needsMaintain accurate information in planning, tracking, and reporting toolsEnsure consistent communication across ClinDoc functionsCoordinationOversee writing activities across teams and vendorsMentor junior writers and review contract workQuality & TrainingDevelop training programs and documentation standardsBuild effective relationships with stakeholders and partnersAbout youCore Experience:Six+ years as medical writer or equivalent specialist roleProven track record leading multiple clinical documentation projectsExpert in clinical documentation preparationClinical Development Knowledge:Demonstrated expertise in clinical development processesStrong understanding of clinical study methodology and basic statisticsKnowledge of regulatory environmentProficient in document management systems and authoring platformsProfessional Attributes:Strong attention to detail and deadline managementExcellent organizational and follow-up abilitiesProven ability to work independently and in global teamsTechnical skills:Expertise in electronic document management and Microsoft OfficeProven experience in implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions.Education: Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified.Languages: Proficient in written and spoken English.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 its 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 applicantswill receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domesticpartnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liabilityfor military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) orany other characteristic protected by law.#GD-SA #LI-SA#LI-Remote#vhdAll 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.

Created: 2025-09-24