Associate Director / Principal Medical Writer
📍 Location: Remote, USA (Proximity to Cambridge/Boston, MA or Morristown, NJ preferred)
💰 Salary Range: USD 147,000 – 212,333 per year
🏢 Company: Sanofi
🌐 Work Type: Remote (with occasional team meetings onsite)
About Sanofi
Sanofi is a global healthcare leader committed to transforming the practice of medicine through scientific innovation. Our work spans oncology, rare diseases, neurology, and vaccines, integrating AI-powered discovery with deep scientific expertise to bring breakthroughs to life.
We’re dedicated to empowering your growth, encouraging leadership, and pushing the limits of what’s possible in global healthcare.
Position Overview
The Principal Medical Writer plays a key leadership role in clinical documentation and regulatory submission writing. This role requires an experienced professional skilled in authoring, reviewing, and managing clinical and regulatory documents, ensuring quality, compliance, and timely delivery.
You will collaborate with cross-functional clinical teams globally, contribute to strategic documentation planning, and mentor junior writers while driving innovation in digital medical writing (including AI and content re-use).
Main Responsibilities
Clinical and Regulatory Writing
Prepare, review, and coordinate clinical study reports, protocols, investigator brochures, and regulatory submission documents (e.g., CTD modules).
Ensure all documents meet global regulatory standards and company procedures.
Produce high-quality English-language clinical documents that accurately reflect clinical opinions and data.
Leadership and Project Management
Act as lead medical writer on multiple projects and submissions.
Coordinate medical writing activities across internal teams and external CROs.
Mentor and train junior writers, fostering consistency and quality across documentation.
Collaboration and Cross-Functional Work
Work closely with Clinical Trial Teams, Regulatory Affairs, Data Management, and Operations.
Review development plans and propose efficient documentation strategies.
Provide responses to Health Authority queries on submission dossiers.
Innovation and Continuous Improvement
Drive initiatives to implement new technologies such as AI-assisted authoring and content re-use systems.
Lead cross-functional projects to enhance efficiency, reduce costs, and improve document quality.
Contribute to process improvement, training, and global standardization efforts.
Qualifications and Requirements
Education
Advanced degree in Life Sciences, Pharmacy (PharmD), Medicine (MD), or Ph.D. in a relevant scientific field.
Experience
6+ years of experience as a Medical Writer in a pharmaceutical or clinical research environment.
Proven experience in major regulatory submissions (NDA, BLA, MAA).
Strong understanding of clinical development, study methodology, and regulatory guidelines.
Skills
Exceptional English writing and editing skills (native-level or equivalent).
Expertise in Microsoft Word and electronic document management systems.
Strong leadership, project management, and communication abilities.
Interest and proficiency in AI, automation, and digital content systems.
Meticulous attention to detail and ability to work under tight deadlines.
Desirable Knowledge
Prior experience in targeted therapeutic areas (oncology, rare diseases, neurology, etc.).
Familiarity with content reuse strategies and AI-driven medical writing tools.
Why Join Sanofi
✨ Purpose-Driven Work: Help bring the miracles of science to life.
🚀 Career Growth: Countless global opportunities for leadership and skill development.
💼 Comprehensive Benefits:
High-quality healthcare and wellness programs
At least 14 weeks of gender-neutral parental leave
Competitive compensation and recognition programs
🌍 Inclusive Culture: Sanofi is an Equal Opportunity Employer committed to diversity, equity, and inclusion.
Equal Opportunity Statement
Sanofi and its U.S. affiliates provide equal employment opportunities to all qualified applicants, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, gender identity, age, disability, or veteran status.
How to Apply
🔗 Apply online at Sanofi Careers
📺 Watch “One Day at Sanofi” and explore our Diversity, Equity & Inclusion initiatives.
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