Senior Medical Writer
Regeneron · United States · Yesterday
RemoteRemoteScience$129k–$210k/yrFull-time
About the role
Join our Medical Writing team, supporting clinical document delivery across Global Development in a remote work mode. Contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Responsibilities
- Author clinical study reports (CSRs), protocols, informed consent forms (ICFs), narratives, investigator brochures, and other regulatory documents across therapeutic areas.
- Represent Medical Writing at meetings, drive document development, and articulate strategy and timelines.
- Identify the right parties for content decisions and synthesise discussions into clear, accurate prose.
- Review work of junior or outsourced writers and CSR-related documents like Statistical Analysis Plans and TFLs.
- Write plain-language content such as ICFs and explain complex medical concepts to lay audiences.
- Adhere to applicable guidelines, templates, SOPs, and internal training while contributing to process improvement across Medical Writing and Global Development.
- Mentor junior staff, manage multiple priorities, and foster collaboration to resolve conflict.
Requirements
- Bachelor's degree required; advanced degree preferred.
- Minimum 3 years of medical writing experience, including working knowledge of biostatistics.
- Strong knowledge of the clinical research process and applicable regulations, including ICH GCP.
- Clinical document reading, writing, and editing experience.
- Strong knowledge of MS Word, Adobe Acrobat, PowerPoint, and electronic document management systems.
- Ability to manage multiple projects with strong organizational, interpersonal, and communication skills.
Qualifications
- Not specified.
Skills
- Not specified.
Benefits
- Not specified.
Pay
$128,600.00 - $210,000.00 annually
Schedule
Remote work mode