Medical Writer - Remote US

Sarah Cannon Research Institute; Nashville (TN); Remote; USD 70,000 - 110,000; Full time

Benefits offered by this job

Total Rewards package

Bonus or long-term incentives (may be 

Competitive compensation

Job summary

Sarah Cannon Research Institute (SCRI) is a global oncology research organization conducting community-based clinical trials. We advance therapies for patients with cancer and collaborate across 20+ states.

The Medical Writer will research, write, and edit clinical documents, work with Sponsors and cross-functional teams on deliverables, and ensure timely submission readiness. This is a remote position based in the United States; relocation assistance and visa sponsorship are not available.

Qualifications

• Bachelor's Degree required
• Master's Degree preferred
• 3+ years' work experience as a Medical Writer
• Experience with oncology clinical trials
• Thorough understanding of GCP and ICH guidelines
• Advanced user experience with Microsoft Office

Responsibilities

• Write clinical documents for regulatory submissions (Protocols, Informed Consent, Clinical Study Reports)
• Serve as Medical Writing representative on project teams with timelines for deliverables
• Manage document version control for study deliverables
• Identify potential project challenges and propose solutions to PM and Sponsor
• Conduct literature searches to support document development
• Act as primary Sponsor point of contact for assigned project
• Ensure Medical Editing review of drafts before distribution (copyediting and content)
• Perform other duties as assigned

Skills

Medical Writing

Oncology clinical trials

GCP/ICH guidelines

MS Office

SCRI SOPs

Education

Bachelor's Degree

Master's Degree

Job description

It’s More Than a Career, It’s a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

Medical Writer

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.

Job duties include and are not limited to:

• 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 include:

• 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

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.