Clinical Trials Medical Writer

🔥 3 hours ago

🗽 New York – Remote

🗽 New York – Remote

💵 $77k - $92k / year

⏰ Full Time

🟢 Junior

🏥📝 Medical Writer

👻 Ghost score 0%

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Rochester Regional Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

📚 Education

Healthcare • Healthcare Insurance • Education

Rochester Regional Health is an integrated health services organization serving the people of Western New York. It operates multiple hospitals and healthcare facilities, providing a wide range of healthcare services, including emergency care, primary care, specialty clinics, and urgent care. The organization is committed to medical education and research, offering training programs, residencies, and clinical trials. Rochester Regional Health focuses on comprehensive care with emphasis on treating patients respectfully and meeting their diverse medical needs across all stages of life.

📋 Description

• Interpret complex clinical study protocols and medical/scientific documentation • Develop, revise, maintain, author, and finalize clinical study documents, amendments, global lab specification documents, and lab manuals • Identify and resolve documentation gaps and complex study queries • Serve as a subject-matter expert for medical documentation throughout the study lifecycle • Lead and manage internal and external document review rounds • Coordinate collaboration among stakeholders and cross-functional groups • Participate in client interactions during study start-up and amendment processes • Review GLSDs and lab manuals according to SOPs and Quality Assurance processes • Maintain working knowledge of applicable clinical-trial regulations • Pursue professional self-development and perform other assigned duties

🎯 Requirements

• BA/BS, or equivalent experience in scientific field • 1 year of clinical trials or other laboratory experience required • Applied knowledge of routine document content preparation, including style guides, medical dictionaries, regulatory guidance documents, and templates • Proficient in Microsoft Office and desktop publishing or word processing • Education in medical or technical writing • 1+ years’ experience drafting clinical trials documentation • Working knowledge of FDA, MHRA, NYSDOH, GCP, ICH, and other pertinent regulations • Ability to work Monday–Friday, 40 hours per week • Must sit on the East Coast • Ability to perform sedentary, primarily office-based work with prolonged sitting • Fine motor skills for computer work, writing, and telephone use • Clear visual and auditory ability • Flexible hours, TB screening, or a valid driver’s license may be required for some roles

🏖️ Benefits

• Eligible for additional pay components • Potential accommodations for reported physical requirements • Equal Opportunity Employer