Clinical Research Writer

Arthrex

. Manage clinical research writing from initial study concept through study completion, final report, and publication .

Posted 11/12/2026full-timeRemote • Florida • United StatesMid-LevelSenior💰 $105,000 - $127,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research writing, including the preparation of study protocols and reports, while adhering to medical device regulations and guidelines. Proficient in managing timelines and collaborating with cross-functional teams to ensure scientific accuracy and clarity in deliverables.

Highest-signal resume keywords

Clinical Research WritingMedical Device RegulationsStatistical Data InterpretationScientific Writing CertificationOrthopedic Medical Terminology

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Research DesignStatistical AnalysisLiterature SearchDocument PreparationData ReviewProject ManagementTechnical WritingProtocol DevelopmentPublication Manuscript WritingClinical Study Reporting

Soft Skills

Analytical SkillsProblem-Solving SkillsCommunication SkillsInterpersonal SkillsCollaboration Skills

Tools & Technologies

WordExcelPowerPointPubMedEmbase

Certifications & Qualifications

Medical Writing Certification

Industry Keywords

EU MDR 2017/745FDA 21 CFR 812ISO 14155Biomedical DatabasesClinical Research

About the role

Key responsibilities & impact

Manage clinical research writing from initial study concept through study completion, final report, and publication
Perform comprehensive literature searches to support clinical study design
Apply scientific and research methodology and medical device regulations and guidelines to clinical research writing
Extract statistical data summaries, study conduct information, and study design information for interim and final study reports
Prepare clinical study documents
Coordinate with product management, statisticians, regulatory affairs, clinical research teams, and contract research organizations
Manage timelines for writing deliverables and communicate progress to cross-functional teams
Review clinical and scientific deliverables for scientific accuracy, technical correctness, clarity, and conciseness
Develop and review PMCF protocols and reports, Arthrex- and investigator-initiated study protocols and reports, and manuscript drafts
Ensure documents follow procedures, internal and external guidelines, and electronic templates

Requirements

What you’ll need

Experience and degree in science, engineering, or medical fields
Scientific/research background, including understanding of research design, methodology, and statistics
Working knowledge of EU MDR 2017/745, FDA 21 CFR 812, and ISO:14155
Working knowledge of biomedical databases, including PubMed and Embase
Proficiency in Word, Excel, and PowerPoint
Demonstrated analytical and problem-solving skills
Ability to independently manage a large workload with minimal supervision
Ability to prioritize projects and activities in a time-constrained setting
Strong oral and written communication skills
Excellent interpersonal communication, relationship-building, and collaboration skills
Ability to translate scientific and statistical concepts into concise, accurate, audience-appropriate content
Proficiency reviewing and interpreting data tables, listings, figures, and statistical outputs
Master’s degree required; PhD preferred
4 years of relevant clinical research experience required
2 years of research/scientific writing experience in the medical device industry required
Strong knowledge of orthopedic medical and surgical terminology required
Previous experience writing study protocols, publication manuscripts, interim study reports, and final study reports required
Ability to share examples of previous writing projects
Medical writing or research certification required, or willingness to obtain it within one year

Benefits

Comp & perks

Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Gym Reimbursement Program
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
Fully remote work arrangement
Periodic travel to the Naples, Florida headquarters as business needs require