Job Description
Job Title: Medical Writer Location: Morristown, NJ
About the Job Join the engine of Sanofi’s mission - where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
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.
Sanofi is seeking a highly organized, detail-oriented Medical Writer to join our team. In this role, you will develop regulatory-compliant clinical documents supporting our product lifecycle while embracing innovative digital solutions. The ideal candidate will possess excellent communication skills, regulatory acumen, and the ability to work independently on multiple projects within tight deadlines. You should have an in-depth understanding of medical terminology and the ability to interpret complex data for various stakeholders. We are looking for a creative and passionate candidate eager to contribute to our mission of developing innovative solutions to improve people's health and well-being.
About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities: Document DRevelopment - Create high-quality regulatory-compliant clinical documents supporting product life cycle
- Ensure timely delivery while maintaining compliance with company SOPs and guidelines
Innovation - Support implementation of new digital technologies and AI solutions
- Participate in process improvements for efficiency gains
Regulatory Expertise - Prepare clinical documents for registration dossiers and Health Authority responses under guidance
- Maintain awareness of regulatory documentation requirements
Communication - Work effectively with cross-functional teams
- Update relevant stakeholders on project progress and needs
- Maintain accurate information in planning, tracking, and reporting tools
Coordination - Oversee writing activities from vendors
- Review vendor deliverables
Quality & Training - Ensure consistent document style and adherence to company standards
- Build effective relationships with stakeholders and partners
About You Basic Qualifications: - Must be currently enrolled in 2024-2026 Rutgers Sanofi PharmD Fellows Program
- At this time, Sanofi will not sponsor a new applicant for employment authorization, or offer any immigration related support for this position (i.e. H1B, F-1 OPT, F-1 STEM OPT, F-1 CPT, J-1, TN, or another type of work authorization).
- Minimum 1 year as medical writer or equivalent experience in Clinical Research preferably in pharma
- Experience in preparing clinical documents and regulatory submissions
- Basic understanding of clinical development processes
- Knowledge of clinical study methodology and basic statistics
- Familiarity with regulatory environment and medical terminology
Preferred Qualifications: - Proficient in document management systems and authoring platforms
- Ability to clearly, accurately, and concisely write/prepare clinical documents in English
- Strong attention to detail and deadline management
- Strong organizational and follow-up abilities
- Ability to work independently and in global teams
- Proficiency in electronic document management and Microsoft Office
- Interest in implementing emerging innovative digital technologies, including 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.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
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.
Job Tags
Permanent employment, H1b, Work at office,