Senior Medical Writer

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 are seeking a Senior Medical Writer to apply advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

Requirements

• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
• Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
• Represents Global Medical Writing at cross-functional team meetings (e.g., study team, development team, other sub teams)
• Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
• Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments