Clinical Research Writer
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Job Description
Clinical research writer supporting Arthrex, a global orthopedic medical-device company. Developing protocols, reports, manuscripts, and regulatory clinical-study documents.
Responsibilities:
- 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:
- 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:
- 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
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