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  • 3322 West End Avenue
    Nashville, TN 37203

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Medical Writer - Work From Home

Sarah Cannon Clinical Operations • Nashville, TN

Posted 28 days ago

Job Snapshot

Full-Time
Degree - 4 Year Degree
Healthcare - Health Services
Science, Legal, Health Care
26

Applicants

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Job Description

SarahCannon, the Cancer Institute of HCA Healthcare, offers integrated cancerservices with convenient access to cutting-edge therapies for those facing cancerin communities across the United States and United Kingdom. Sarah Cannon’scancer programs include individualized patient navigation provided byoncology-trained nurses, more than 1,000 stem cell transplants performedannually throughout the Sarah Cannon Blood Cancer Network, hundreds of clinicaltrials, and molecular profiling capabilities. Through its services, SarahCannon is providing state-of-the-art cancer care close to home for hundreds ofthousands of patients, a number unmatched by any single cancer center.
 
By bringing together a network ofglobally-recognized cancer experts, we are collaborating and sharing bestpractices that address every aspect of the cancer journey, from screening anddiagnosis through treatment and survivorship.
 
Sarah Cannon Research Institute is theresearch arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focusedon advancing therapies for patients, it is one of the world’s leading clinicalresearch organizations conducting community-based clinical trials throughoutthe United States and United Kingdom. Sarah Cannon’s network of strategic sitesincludes more than 275 physicians who engage in research. The organization hasled more than 260 first-in-man clinical trials since its inception in 1993, andhas been a clinical trial leader in the majority of approved cancer therapiesover the last 10 years.

Summary of Key Responsibilities:
This position will have the overall responsibility for researching, writing, and editing clinical reports, protocols, and other related documents in multiple therapeutic areas. The Medical Writer will work in conjunction with other SCRI Development Innovations Departments and Sponsors, as appropriate, for the effective preparation and timely delivery of contracted material.
 
Duties and Responsibilities:
Duties include but are not limited to:
  • Write clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, informed consents, clinical study reports, periodic regulatory 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 documents created by Medical Writing department, as applicable Identify any potential project challenges including changes in project plan, timeline or out of scope requests, and suggest possible resolution options to 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 contact for clinical document writing on an assigned project Ensure medical editing review of draft and final documents before external distribution. This includes both copyediting and content review. Completion of projects in accordance with established timelines Maintaining consistency of style and developed formats, templates, content for IND submissions, and guidelines for clinical documentation in support of scientists. Preparation of Investigator’s Brochures and other documentation in support of clinical programs including study abstracts and regulatory documents.
  • Assisting clinical and regulatory teams prepare and write phase I-IV clinical and regulatory documents such as clinical study protocols, study reports, Annual regulatory reports, etc.
  • Preparation of clinical documents in accordance with templates, global standards, FDA, ICH, and GCP guidelines and in accordance with electronic publishing standards (when applicable).
  • Participate in departmental or interdepartmental process improvement and training initiatives.
  • Participate in development of templates and guidelines for clinical documentation and workflow procedures.
  • Assist in the development of departmental SOPs.
  • Keep abreast of professional information and technology and assist department Director in ensuring appropriate transfer of information to the department.
  • Training of incoming Medical Writers.
  • Adhering to SCRI Services SOPs and applicable Guidance Documents.
  • Participating in educational activities and programs.
  • Maintaining strictest confidentiality.
  • Performing related work as required.
  • Practicing and adhering to the SCRI “Code of Conduct” philosophy and “Mission and Value Statement.”
Mandatory
  • Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement” 
  • During your employment with SCRI you will be routinely assigned training requirements. Youare expected to complete any training assignments by the due date.

Job Requirements

Competencies:
  • Knowledge: A body of information needed to perform tasks; May be obtained through education,training or experience
    • Thorough understanding of GCP, ICH guidelines 
    • Knowledge of FDA and EMA regulations 
  • Skills: The proficiency to perform a certain task 
    • Excellent problem-solving, planning, analytical, and organizational skills. 
    • Strong Microsoft word, excel skills 
    • Strong verbal, written and interpersonal communication skills 
    • Flexible attitude with respect to work assignments and new learning opportunities. 
    • Ability to multitask and prioritize workload with attention to detail required
  • Abilities: An underlying, enduring trait useful for performing duties 
    • Ability to work within deadlines. 
    • Adhering to SCRI Services SOPs and applicable Guidance Documents. 
    • Participating in educational activities and programs. 
    • Maintaining strictest confidentiality. 
    • Performing related work as required. 
    • Practicing and adhering to the SCRI “Code of Conduct” philosophy and “Mission and ValueStatement.” 


Education:

Minimum Required: Bachelor's College Degree (4 yr program)
Preferred: Master's Degree (1-2 yr program)


Experience:
Minimum Required:
  • Two to three years minimum of relevant medical writing experience or relevant clinical researchexperience. 
  • Two years’ experience as a CRA/Study Manager, compliance auditor, or a combination inhealthcare, clinical research or other science-related field. 
  • Experience with preparation of clinical study-related documents and/or research publicationsdesired; experience with regulatory documents and processes beneficial. 
  • Or equivalent experience
Preferred:

  • Clinical research/medical writing experience: experience, including phase I- III, in writingmultiple clinical study reports, and either CTD documents or similar, or study protocols

Job ID: 25319-4472
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