HCA, Hospital Corporation of America Sr. Medical Writer, Work From Home in Nashville, Tennessee
Sarah Cannon, the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.
By bringing together a network of renowned cancer experts, we are collaborating and sharing best practices that address every aspect of the cancer journey from screening and diagnosis through treatment and survivorship so that patients can receive quality care with improved outcomes.
Our research arm, Sarah Cannon Research Institute (SCRI), formed more than 20 years ago to ensure patients could access cutting-edge therapies closer to home. In partnering with leading pharmaceutical/biotech companies and investigators, we offer more than 500 clinical trials annually.
Collectively, our comprehensive patient-centric services ensure that we are fulfilling our mission to advance science and transform care.
Sr. Medical Writer, Work From Home – We Are Hiring – Apply Online Today!
Summary of Key Responsibilities: Provides medical writing leadership in the development of clinical documents. Works closely and effectively with Study Chairs, Sponsors, project managers, and study teams in multiple therapeutic areas ensuring Sponsor timelines are met.
Duties and Responsibilities:
Duties include but are not limited to:
Write, edit, and manage the production of clinical study reports, Investigator Brochures, and clinical and regulatory summary documents in accordance with templates, global standards, FDA, ICH, and GCP guidelines and in accordance with electronic publishing standards (when applicable)
Provide administrative support for Medical Writing team members as required (e.g., timesheet approval, PTO coverage)
Develop and maintain a core set of templates necessary to ensure compliance with regional regulatory requirements
Manage the Medical Writing workload including the development and maintenance of a status reporting system. Responsible for reporting status of all projects to management and Sponsors (when applicable)
Develop and maintain file management and collaboration systems (e.g., MySCRI portal)
Develop and maintain Medical Writing SOPs
Establish and maintain professional relationships with internal/external clients to ensure creative and collaborative exchanges
Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
Update Sponsor templates in the MW Library as they become available
Complete projects in accordance with internally established timelines
Train and mentor new and existing team members
Participate in educational activities and programs
Maintain strictest confidentiality
Perform related work as required
Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”
During your employment with Sarah Cannon you will be routinely assigned training requirements. You are expected to complete and training assignments by the due date.
Knowledge:/A body of information needed to perform tasks; May be obtained through education, training or experience/
Thorough understanding of GCP, ICH guidelines and local regulations.
Knowledge of clinical trials design, the oncology disease process, basic statistics, pharmacokinetics and other aspects of the drug/clinical trial development.
Skills:/The proficiency to perform a certain task/
Excellent problem-solving, planning, analytical, and organizational skills.
Strong verbal, written and interpersonal communication skills are essential.
Skill with Microsoft Office products, including Outlook, Word and Excel.
Flexible attitude with respect to work assignments and new learning opportunities.
Abilities:/An underlying, enduring trait useful for performing duties/
Ability to work within deadlines.
Ability to multitask and prioritize workload with attention to detail required.
Minimum Qualifications: Bachelor’s degree (4 Yr Program)
Preferred: Master’s Degree
- Three years minimum of relevant medical writing experience or relevant clinical research experience.
Two years’ experience as a CRA/Study Manager, compliance auditor, or a combination in healthcare, clinical research or other science-related field – if document preparation was a primary responsibility.
Experience with preparation of clinical and/or regulatory study-related documents and/or research publications desired; experience with regulatory documents and processes beneficial.
Clinical research/medical writing experience: experience, including phase I- III, in writing multiple clinical study reports, and either CTD documents or similar, or study protocols.
Title: Sr. Medical Writer, Work From Home
Location: Tennessee-Nashville-Sarah Cannon Research Institute Clinical Operations
Requisition ID: 25319-3502