Senior Medical Writer
About The Position
The Sr. CMC Medical Writer is responsible for providing clinical, scientific, technical writing, and project coordination expertise for essential clinical and chemistry, manufacturing, and controls (CMC) documents submitted to the FDA and other regulatory agencies to support St. Jude's clinical development pipeline, as well as technical reports containing source data. This role serves not only as a key contributor to content development but also as a central project facilitator—driving cross-functional alignment, ensuring timely execution, and coordinating activities across stakeholders to support successful delivery of clinical and CMC documentation for clinical programs.
Requirements
- Bachelor's degree in communications, journalism, English, Biomedical sciences, Regulatory Affairs or related field required.
- 4+ years of experience in communications, journalism, English, Biomedical sciences or related field.
- Demonstrated experience in writing in life sciences or healthcare environment.
- Proven performance in earlier role/comparable role.
Nice To Haves
- Master's degree OR PhD preferred.
- Some experience stakeholder management preferred.
Responsibilities
- Review, analyze, audit, and organize existing content to ensure quality, accuracy, and consistency across IND and IDE CMC projects, while ensuring compliance with organizational standards and alignment with business objectives.
- Develop customized content elements from various stakeholder groups and distribution channels, with a focus on St. Jude-sponsored INDs and IDEs.
- Serve in a project management capacity by coordinating activities across cross-functional teams (e.g., clinical, regulatory, quality, manufacturing), facilitating communication, tracking deliverables, and proactively identifying and resolving risks or bottlenecks.
- Develop and maintain project timelines, monitor progress against milestones, and ensure alignment with quality guidelines, regulatory expectations, and program objectives.
- Lead or support project meetings, including agenda development, documentation of key decisions, and follow-up on action items to ensure accountability and progress.
- Provide guidance, assistance, and mentoring support to less experienced colleagues on both writing processes and effective project coordination practices.
- Contribute to continuous improvement of document development workflows, project tracking tools, and cross-functional collaboration processes.
- Perform other duties as assigned to meet the goals and objectives of the department and institution.
- Maintain regular and predictable attendance.
Benefits
- work-life balance
- generous paid time-off
- on-campus conveniences
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What This Job Offers
Job Type
Full-time
Career Level
Senior
