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
🧬 About the Role
The Principal Medical Writer (Associate Director level) serves as a senior expert in clinical documentation, leading the authoring, coordination, and management of regulatory and clinical documents that support drug development and approval processes.
This role requires scientific precision, leadership in submission management, and strong collaboration with Clinical and Regulatory teams to ensure timely and compliant document delivery.
⚙️ Key Responsibilities
Lead the preparation, review, and submission of clinical and regulatory documents (e.g., CSRs, CTD modules, Investigator’s Brochures, responses to health authorities).
Ensure accuracy, clarity, and compliance with global regulatory standards and internal quality procedures.
Collaborate with cross-functional teams including Clinical Trial Teams (CTT), Regulatory Affairs, and Biostatistics.
Mentor and train junior medical writers, providing leadership and quality oversight.
Manage and review external medical writing vendors and CRO partners.
Participate in transversal initiatives to improve document management systems and implement AI-driven writing tools and content reuse strategies.
Serve as Subject Matter Expert (SME) on process optimization and digital documentation solutions.
Lead special projects introducing innovative content automation and AI-assisted authoring.
Ensure consistency and scientific integrity across all documents submitted to regulatory authorities.
🎓 Education & Experience
Advanced degree (M.Sc., Pharm.D., Ph.D.) in Life Sciences, Medicine, Pharmacy, or related field.
Minimum 6+ years of experience as a Medical Writer, preferably with leadership or submission lead responsibilities.
Strong understanding of clinical research methodology, regulatory writing, and submission processes (EU/US).
Experience leading global submission dossiers (eCTD modules) and complex document projects.
Technical proficiency in Microsoft Word, electronic document management systems (EDMS), and familiarity with AI/digital documentation tools.
🧠 Key Skills
Excellent command of English writing and editing.
Strong leadership and interpersonal skills with ability to guide multi-functional teams.
High attention to detail, organization, and deadline orientation.
Strategic mindset with ability to improve processes and drive innovation.
Familiarity with clinical development, pharmacovigilance, and regulatory frameworks (ICH, FDA, EMA).
🌍 Job Category
Medical Writing / Regulatory Affairs / Clinical Documentation Management
💡 Why Join Sanofi
Work at the intersection of science, innovation, and digital technology.
Be part of a global, future-focused team driving regulatory excellence.
Enjoy career growth opportunities through international exposure and leadership development.
Comprehensive benefits package, including health coverage, wellness programs, and 14 weeks of gender-neutral parental leave.
Inclusive workplace culture — Equal Opportunity Employer promoting diversity, equity, and inclusion.
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