Medical Writer

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Conduct research, compose, and refine documents across various therapeutic domains

• Prepare clinical documents for regulatory submissions, including Clinical Study Protocols, Informed Consent forms, and Clinical Study Reports

• Act as the Medical Writing representative on designated project teams

• Provide timelines for Medical Writing outputs and contribute to the timelines of other departmental deliverables

• Oversee version control of Medical Writing documents for study outputs

• Recognize project obstacles, modifications to plans or timelines, and out-of-scope requests; propose solutions

• Execute literature searches and reviews to gather background information and support clinical document development

• Serve as the main point of contact for sponsors regarding clinical document writing on assigned projects

• Ensure thorough Medical Editing reviews of both draft and final documents, encompassing copyediting and content assessment

• Carry out additional responsibilities as assigned

⛳️ Requirements

• A Bachelor's Degree is required

• A Master's Degree is preferred

• Over 3 years of experience as a Medical Writer, ideally in the clinical research field

• Familiarity with oncology clinical trials is essential

• Comprehensive knowledge of GCP and ICH guidelines

• Proficient user of all Microsoft Office applications

• Compliance with SCRI SOPs and relevant guidance documents is necessary

• Must reside in the United States

• Relocation assistance and visa sponsorship are not provided

🏝️ Benefits

• Comprehensive Total Rewards package that promotes physical, mental, and financial wellness

• Competitive salary package

• Opportunities for annual bonuses or long-term incentives may be available

• Benefits offered through parent company McKesson