Remote Oncology Medical Writer for Clinical Trials

McKesson; Tennessee; Hybrid; USD 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Total Rewards package

Zusammenfassung

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Medical Writer to research, write, and edit clinical documents across therapeutic areas. This remote role requires coordinating with sponsors and SCRI teams to ensure timely deliverables.

The ideal candidate has 3+ years of medical writing experience in clinical research, oncology trials, and a solid understanding of GCP/ICH guidelines, with strong Microsoft Office skills and SOP adherence.

Qualifikationen

• 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.

Aufgaben

• 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

Kenntnisse

Medical Writing

Oncology Clinical Trials

GCP/ICH Guidelines

Microsoft Office

SOP Compliance

Ausbildung

Bachelor's Degree

Master's Degree preferred

Jobbeschreibung

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Medical Writer to research, write, and edit clinical documents across therapeutic areas. This remote role requires coordinating with sponsors and SCRI teams to ensure timely deliverables.

The ideal candidate has 3+ years of medical writing experience in clinical research, oncology trials, and a solid understanding of GCP/ICH guidelines, with strong Microsoft Office skills and SOP adherence.