Senior Medical Writer - Remote

Title : Medical Writer

Remote

RESPONSIBILITIES

• 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
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)
• Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2 / Module 5 clinical or integrated summaries).
• 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 (eg, study team, development team, other subteams).
• 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

EXPERIENCE

Clinical Studies

EDUCATION