[Hiring] Medical Writer @Sarah Cannon Research Institute

Role Description

The 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.

• 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

• 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 to support physical, mental, and financial well-being.
• Competitive compensation package determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets.
• Other compensation, such as an annual bonus or long-term incentive opportunities may be offered.