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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

Sr. Medical Writer

Job 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.

Minimum Education and/or Training:

• Bachelor's degree in communications, journalism, English, Biomedical sciences, Regulatory Affairs or related field required.
• Master's degree OR PhD preferred.

Minimum Experience:

• Minimum Requirement: 4+ years of experience in communications, journalism, English, Biomedical sciences or related field.
• Demonstrated experience in writing in life sciences or healthcare environment.
• Some experience stakeholder management preferred.
• Proven performance in earlier role/comparable role.

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $78,000 - $139,360 per year for the role of Senior Medical Writer.

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St. Jude is an Equal Opportunity Employer

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St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.