Medical Writer - Remote US

Sarah Cannon Research Institute•Usa, TN

2d•Remote

About The Position

Our Medical Writer will have the overall responsibility for researching, writing, and editing a variety of documents across multiple therapeutic areas. The Medical Writer will work in conjunction with other Sarah Cannon Research Institute departments and Sponsors, as appropriate, for the effective preparation and timely delivery of contracted material. This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

Requirements

Bachelor's Degree required
3+ years' work experience as a Medical Writer, preferably within the clinical research industry
Experience with oncology clinical trials
Thorough understanding of GCP and ICH guidelines
Advanced user experience with all Microsoft Office products
Adherence to SCRI SOPs and applicable guidance documents

Nice To Haves

Master's Degree preferred

Responsibilities

Write clinical documents associated with submissions to regulatory authorities, including but not limited to Clinical Study Protocols, Informed Consents, and Clinical Study Reports
Serve as the Medical Writing representative on assigned project teams, providing timelines for Medical Writing deliverables and Medical Writing input into other departmental deliverables
Responsibility for Medical Writing document version control for study deliverables created by the Medical Writing department
Identify any potential project challenges, including changes in project plans or timelines or out-of-scope requests and suggest possible solutions to the Project Manager and Sponsor
Perform literature searches/reviews as necessary to obtain background information and training for development of clinical documents
Serve as the primary Sponsor point of contact for clinical document writing on an assigned project
Ensure Medical Editing review of draft and final documents before external distribution, which includes both copyediting and content review.
Other duties as assigned