Senior Medical Writer/Medical Writer

Job Overview Sr. Medical Writer is responsible for providing clinical, scientific, and technical writing expertise for essential clinical, chemistry, manufacturing, and controls (CMC) documents submitted to the FDA and other regulatory agencies to support St. Jude's clinical development pipeline. The role also involves developing medical content, digital materials, and web‑based resources for employees, patients, and families. Responsibilities Serve as the institution’s primary point of contact for the CMC portion of FDA research INDs. Review, analyze, audit, and organize existing content to ensure quality, accuracy, and compliance with organizational standards. Write customized content elements for the CMC portion of FDA research INDs, primarily for PhaseI and PhaseII studies. Maintain current knowledge of eCTD submissions within Modules2 and3. Track project activities and ensure alignment with quality guidelines, project timelines, and objectives. Mentor and support less experienced colleagues on routine processes and procedures. Conduct interviews with patients, families, faculty, and staff and write stories for publication deadlines. Research, write, and edit copy for diverse communication tools such as articles, e‑books, videos, webinars, infographics, case studies, and blog posts. Collaborate with partner agencies, graphic designers, communications, and information technology teams to develop compelling content. Ensure quality and accuracy across all projects and maintain compliance with organizational standards. Create and manage content projects to ensure continuous delivery of new and refreshed content. Perform additional duties as assigned to meet departmental and institutional goals. Maintain regular and predictable attendance. Qualifications Education: Bachelor’s degree in communications, journalism, English, biomedical sciences, or a related field is required; Master’s degree or PhD preferred. Experience: Minimum 2–4years of relevant experience in communications, journalism, English, or biomedical sciences, with 4years or more preferred. Demonstrated experience writing in a life sciences or healthcare environment. Experience with stakeholder management and collaboration across multiple departments. Proven performance in a similar or comparable role. Knowledge of regulatory guidance, FDA CMC requirements, and eCTD submissions is desirable. Strong written and verbal communication skills, with the ability to translate complex scientific concepts for diverse audiences. Compensation Estimated salary range: $78,000 – $139,360 per year. EEO Statement St. Jude is an Equal Opportunity Employer. #J-18808-Ljbffr