Clinical Trials Medical Writer

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🗽 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, review, edit, coordinate, and finalize clinical study documents and amendments • Author and finalize global lab specification documents and related documents • Interpret scientific details and identify and resolve documentation gaps • Serve as a subject-matter expert for medical documentation throughout the study lifecycle • Lead and manage internal and external document reviews • Coordinate stakeholders to ensure high-quality, compliant technical documentation • Participate in client interactions during study start-up and amendment processes • Review global lab specification documents and lab manuals according to SOPs and Quality Assurance processes • Develop, revise, maintain, and review lab manuals • Resolve challenges, build consensus, and resolve complex-study queries • Perform other assigned duties and tasks

🎯 Requirements

• BA/BS, or equivalent experience in scientific field • 1 yrs clinical trials or other laboratory experience required • Applied knowledge of routine document content preparation, including the use of 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 • Excellent communication skills • Ability to effectively influence others, work in a team environment, and collaborate across lines of business and functions • 1+ years’ experience drafting clinical trials documentation • Ability to maintain working knowledge of FDA, MHRA, NYSDOH, GCP, ICH, and other pertinent regulations • Ability to work 40 hours per week, Monday–Friday daytime schedule • Sedentary work; ability to exert up to 10 pounds of force occasionally

🏖️ Benefits

• Equal Opportunity Employer protections • Potential additional pay components