Rochester Regional Health

Clinical Trials Medical Writer

Rochester Regional Health

full-time

Posted on:

Location Type: Remote

Location: New YorkUnited States

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Salary

💰 $77,000 - $92,000 per year

Job Level

About the role

  • Interpret complex clinical study protocols and other medical/scientific documentation
  • Prepare and coordinate laboratory specification and study-specific medical/technical documents
  • Partner with internal departments in document development, drafting, review, editing, and finalization
  • Manage multiple rounds of internal and external document review
  • Serve as a subject-matter expert (SME) for medical documentation
  • Participate in client interactions during study start-up activities
  • Maintain knowledge of FDA, MHRA, NYSDOH regulations
  • Resolve challenges and build consensus among cross-functional groups and collaborators

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
Benefits
  • Health insurance
  • 401(k) matching
  • Paid time off
  • Remote work options
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical study protocolslaboratory specificationmedical documentationdocument reviewdraftingeditingtechnical writingregulatory guidanceclinical trials documentationstyle guides
Soft Skills
communication skillsinfluenceteamworkcollaborationconsensus buildingproblem-solvingcross-functional collaborationclient interactionorganizational skillsattention to detail