Clinical Evaluations Reports Writer / CER Medical Writer (Pharma/Medical Device)

Location: USA Remote – any time zone

Hours: 20 to 30 hours per week

Comments:

Nature of Role:
• Will work with domestic documents so must have familiarity with authoring documents, scientific publications, data outputs, and data repository to pull documents from.
• Will be creating legend from graphs to text.
• Outputs into templates & creates summary.
• Must have MS Office Suite knowledge specifically Word and PPT Experience in Cardiology is a plus, however 2-3 years of experience must come from Life-Sciences, Medical Device, Pharma, with Regulatory Reports knowledge, and Graphs knowledge.

What You’ll Work On
• Prepare technical documents to support both domestic and international clinical studies.
• Author annual progress reports on clinical trials and studies in Client Structural Heart’s transcatheter edge-to-edge repair portfolio.
• Collaborate with clinical and biometrics to ensure proper content is included in documents.
• Incorporate statistical outputs, text, graphs, charts, and tables into clinical reports or publication projects with high attention to detail in a clear and accurate manner.
• Construct and draft publication projects (abstracts, presentations, manuscripts) for peer-review submissions.
• Review and proofread all types of materials for accuracy, consistency, and clarity.
• Review, circulate, edit, assemble, and inspect submissions.
• Communicate deliverables needed and writing process to team members.
• Utilize templates and format/style guidelines necessary for document type.
• Incorporates text, graphs, charts, tables and statistical analysis.
• Proofreads, circulates, edits, assembles, inspects and duplicates product submissions.
• 3-5 years exp

Qualifications
• 1-3+ years of experience as a medical or technical writer (publications or regulatory).
• Bachelor’s Degree in relevant technical discipline, including biology, engineering, physiology, data science, statistics, or similar.
• Masters Degree preferred.
• Exceptional writing and proofreading skills, experience with AMA Manual of Style.
• Multitasks, prioritizes, and meets deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail

Job Type: Contract

Pay: $42.00 – $44.00 per hour

Expected hours: 40 per week

Benefits:
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off

Schedule:
• 8 hour shift
• Day shift
• Monday to Friday

Education:
• Master’s (Preferred)

Experience:
• Publications writing: 5 years (Preferred)
• Pharma or medical device industry: 5 years (Preferred)
• Author annual progress reports on clinical trials: 5 years (Preferred)
• create documents for clinical studies: 5 years (Preferred)
• scientific publications,: 5 years (Preferred)
• inspects and duplicates product submissions.: 5 years (Preferred)

Work Location: Remote

Location: Remote, OR, US

Offer Expires: 2025-01-29 23:49:02

Salary: 42 – 44

Job Posting Language: en

Benefits:

  • Paid Time Off
  • Health Insurance

Qualifications:

  • 1-3+ years of experience as a medical or technical writer (publications or regulatory)
  • Bachelor’s Degree in relevant technical discipline, including biology, engineering, physiology, data science, statistics, or similar
  • Exceptional writing and proofreading skills, experience with AMA Manual of Style
  • Multitasks, prioritizes, and meets deadlines in a timely manner
  • Strong organizational and follow-up skills, as well as attention to detail

Responsibilities:

  • Hours: 20 to 30 hours per week
  • Will work with domestic documents so must have familiarity with authoring documents, scientific publications, data outputs, and data repository to pull documents from
  • Will be creating legend from graphs to text
  • Outputs into templates & creates summary
  • Prepare technical documents to support both domestic and international clinical studies
  • Author annual progress reports on clinical trials and studies in Client Structural Heart’s transcatheter edge-to-edge repair portfolio
  • Collaborate with clinical and biometrics to ensure proper content is included in documents
  • Incorporate statistical outputs, text, graphs, charts, and tables into clinical reports or publication projects with high attention to detail in a clear and accurate manner
  • Construct and draft publication projects (abstracts, presentations, manuscripts) for peer-review submissions
  • Review and proofread all types of materials for accuracy, consistency, and clarity
  • Communicate deliverables needed and writing process to team members
  • Utilize templates and format/style guidelines necessary for document type
  • Proofreads, circulates, edits, assembles, inspects and duplicates product submissions

Benefits:

  • Pay: $42.00 – $44.00 per hour
  • Expected hours: 40 per week
  • Flexible schedule
  • Health insurance
  • Life insurance
  • Paid time off
  • 8 hour shift

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