Senior Medical Writer at Veristat | Torre

Senior Medical Writer

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Full-time

Legal agreement: Employment

Compensation
USD70k - 110k/year
Non-negotiable
location_on
Hybrid (United States)
Posted almost 6 years ago

Responsibilities


• Conducts overall planning of the clinical sections of global submissions. • Works with manager to develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy. • Advises management regarding project resource requirements, and manages project-related activities of resources assigned. • Reviews statistical analysis plans and case report forms, as required. • Performs quality control (QC) and “peer” review of clinical study reports and other submissions written by other medical writers. • Keeps management informed on progress of documents and other project-related information. • Assists management in projecting resources and performs administrative duties as requested. • Works independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization. • Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet International Conference on Harmonisation (ICH) guidelines and company document standards unless required otherwise by client and agreed per procedure.