Medical Writer

Responsibilities

• Draft and edit clinical study documents, including protocols, amendments, informed consent forms, and clinical study reports
• Prepare documents for reporting aggregate safety and efficacy information, such as investigator’s brochures and periodic safety reports (PBRERs, DSURs)
• Manage study team participation in document preparation by running meetings, developing timelines, and managing review processes
• Provide peer review and editing support for regulatory documents, statistical analysis plans, and CRFs
• Adhere to departmental procedures, technical standards, and industry practices
• Assist in developing and reviewing standard processes and templates within Global Medical Writing
• Collaborate effectively with cross-functional groups within the organization

Requirements

• University-level medical or technical writing course(s) or equivalent experience in science/technical writing
• Up to 2 years of medical writing experience in the pharmaceutical industry OR at least 5 years of scientific writing experience
• Knowledge of the drug development process from discovery to market
• Proficiency in Microsoft Word (including templates), Excel, Adobe Acrobat, and PowerPoint
• Familiarity with document management software such as Veeva or SharePoint
• Ability to interpret basic tabular and graphical clinical data presentations

Preferred Qualifications

• Bachelor’s degree or higher with a scientific focus
• Experience writing or editing protocols and clinical study reports
• Professional certification such as American Medical Writers Association (AMWA) or Editor in Life Sciences
• Understanding of biostatistical and clinical research concepts

About the Company

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. We develop medicines for patients with significant unmet medical need by leveraging unparalleled expertise in genetics and molecular biology.