Medical Writer - Remote US
Sarah Cannon Research Institute
Summary
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.
Job description
Job duties include and are not limited to:
- 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
Qualifications include:
- Bachelor's Degree required, Master's Degree preferred
- 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
Requirements
- Bachelor's Degree required
- Master's Degree preferred
- 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
Benefits
- Comprehensive benefits
- Physical well-being support
- Mental well-being support
- Financial well-being support
- Competitive compensation package
- Annual bonus
- Long-term incentive opportunities
Company overview
Sarah Cannon Research Institute (SCRI) is a premier oncology research organization and global leader in community-based clinical trials. Founded in 2004 through a joint venture between Tennessee Oncology and Hospital Corporation of America, SCRI has established itself as one of the world's leading cancer research institutions. With headquarters in Nashville, Tennessee, the institute operates across more than 200 locations in over 20 U.S. states and the United Kingdom, bringing together more than 1,300 research physicians. SCRI specializes in conducting first-in-human clinical trials, having completed over 850 such studies since its inception, and has contributed significantly to the development of approximately 10 FDA-approved cancer therapies since 1999. The organization focuses primarily on oncology research while also expanding into cardiology, gastroenterology, and other therapeutic areas. SCRI's unique community-based model enables patients to access cutting-edge clinical trials close to home, bridging the gap between academic research centers and local healthcare providers. The institute employs 501-1,000 professionals and maintains strategic partnerships with pharmaceutical and biotechnology companies to advance cancer treatment innovations.