Senior Medical Writer

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $144k - $216k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Responsible for the writing and editing of medical documents (including, but not limited to, clinical protocols, clinical study reports, clinical sections of regulatory submissions and investigator brochures) • Management and prioritization of multiple medical writing projects, acting as senior medical writer • Ensure that documents are reviewed and approved according to the processes described in relevant SOPs and external guidance documents • Maintain document standardisation with the use of model documents/templates ensuring the quality of clinical project documentation • Responsible for the QC of documents written by other authors • Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables • Participate in continuous improvement activities

🎯 Requirements

• Degree: MSc or PhD in a scientific/medical discipline • Minimum of 5 years Medical Writing experience. • Demonstrated ability in the independent production of clinical protocols and reports. • Experience with NDAs, sNDAs, and other regulatory submissions and with electronic regulatory submission requirements (eCTD) • Good understanding of the relevant Health Authority Regulations and guidelines and the drug development process • Self-motivated with a proven ability of working to deadlines • Proficiency in MS Office and experience of working with electronic Document Management systems

🏖️ Benefits

• medical, dental, vision • paid time off • 401(k) plan with employee and company contribution opportunities • life insurance • disability insurance • accident insurance • tuition reimbursement