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About the Role
Regeneron is seeking a Principal Medical Writer to join our Medical Writing team, supporting Global Development in a hybrid work model. This role leads clinical document strategy and development for assigned compounds, collaborating with cross-functional teams in a fast-growing, science-driven organization.
Responsibilities
- Lead clinical document strategy for assigned compounds across therapeutic areas.
- Drive development of CSRs, protocols, ICFs, Investigator’s Brochures, narratives, and regulatory documents.
- Lead submission document writing with Medical Directors, Biostatisticians, and Regulatory Liaisons.
- Represent Medical Writing in document development meetings and guide strategy discussions.
- Oversee junior and outsourced medical writers while contributing independent authoring.
- Review Statistical Analysis Plans and TFLs for clinical document content.
- Contribute to Medical Writing and Global Development process improvement initiatives.
Requirements
- Bachelor’s degree required; advanced degree preferred.
- Minimum 7 years of medical writing experience, including strong biostatistics knowledge.
- Expert knowledge of clinical research processes, regulations, and guidelines.
- Expert experience reading, writing, and editing clinical documents.
- Experience authoring regulatory submission documents, including Module 2 documents.
- Thorough understanding of ICH Good Clinical Practice guidelines.
- Knowledge of applicable guidelines, templates, and SOPs for medical writing.
- Proficiency with Microsoft Word, Adobe Acrobat, PowerPoint, and electronic document management systems.
- Ability to manage multiple projects and competing priorities.
- Excellent organizational, interpersonal, and communication skills.
- Management experience preferred.
Skills
- Biostatistics
- Clinical research processes
- Regulations
- Guidelines
- Reading clinical documents
- Writing clinical documents
- Editing clinical documents
- Authoring regulatory submission documents
- Module 2 documents
- ICH Good Clinical Practice
- Microsoft Word
- Adobe Acrobat
- PowerPoint
- Electronic document management systems
- Project management
- Organizational skills
- Interpersonal skills
- Communication skills
Location
- Tarrytown
- Warren
- Uxbridge
- Dublin
- Tokyo
- Remote
Work Type
- Hybrid
Experience Level
- Principal
- 7 years of medical writing experience
- Management experience preferred
Education Level
- Bachelor’s degree
- Advanced degree preferred
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- Regeneron believes we do our best work when we are together.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.