Job Description

: Responsibilities include preparation of Phase 1 and 2 clinical protocols and integrated clinical and statistical reports in compliance with ICH guidelines, applicable standard operating procedures (SOPs) and working practice documents, and guidelines specified by the FDA and other international regulatory agencies. Protocol preparation involves collaborating with internal and external experts in the development of the study design and facilitating the review of the document by the sponsor and internal project team members. Clinical study report preparation involves interacting with internal experts and sponsors to determine format, design, and presentation of results interpreting and articulating study results using study generated tables, listings, and figures incorporating pharmacokinetic and statistical results and interfacing with internal experts and sponsors to establish the overall study conclusions. Additional responsibilities include demonstrating compliance with internal and sponsor training requirements reviewing statistical analysis plans to ensure clarity and accuracy representing medical writing in project team meetings providing input on medical writing timelines facilitating and participating in internal and external review processes of all deliverables and ensuring that all deliverables meet Clinical Research Group\'s quality standards throughout the life of the project. Responsibilities may also include supporting completion of appendices compilations and electronic publishing representing medical writing in sponsor audits, bid defenses, and capabilities presentations mentoring new medical writers conducting detailed one-on-one training sessions performing peer reviews of deliverables for other medical writers and providing guidance on project management.

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