Medical Writer
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Job Description
Medical Writer developing regulatory and clinical-trial documents for Sarah Cannon Research Institute's oncology research programs. Managing writing, editing, version control, and Sponsor collaboration.
Responsibilities:
- Research, write, and edit documents across multiple therapeutic areas
- Prepare clinical documents for regulatory submissions, including Clinical Study Protocols, Informed Consents, and Clinical Study Reports
- Serve as Medical Writing representative on assigned project teams
- Provide timelines for Medical Writing deliverables and input into other departmental deliverables
- Manage Medical Writing document version control for study deliverables
- Identify project challenges, changes to plans or timelines, and out-of-scope requests; suggest solutions
- Perform literature searches and reviews for background information and clinical document development
- Serve as primary Sponsor point of contact for clinical document writing on assigned projects
- Ensure Medical Editing review of draft and final documents, including copyediting and content review
- Perform other duties as assigned
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
- Must be based in the US
- Relocation assistance and visa sponsorship are not available
Benefits:
- Comprehensive Total Rewards package supporting physical, mental, and financial well-being
- Competitive compensation package
- Annual bonus or long-term incentive opportunities may be offered
- Benefits through parent company McKesson
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