Opportunity Description
Sr. Principal Regulatory Medical Writer - Oncology Preferred Key Responsibilities:
Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross‑functional team members to maintain awareness of review cycles and expectations.
Participate in cross‑functional meetings to provide input regarding medical writing deliverables, timelines, and any processes needed for the completion of regulatory documents.
Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis P...
Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross‑functional team members to maintain awareness of review cycles and expectations.
Participate in cross‑functional meetings to provide input regarding medical writing deliverables, timelines, and any processes needed for the completion of regulatory documents.
Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis P...
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