Clinical Research Writer

Job not on LinkedIn

🔥 13 minutes ago

🐊 Florida – Remote

🐊 Florida – Remote

💵 $105k - $127.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

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👻 Ghost score 6%

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• Just posted.
• Jobs at this company usually fill in 75 days.

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Arthrex

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏭 Manufacturing

🏥 Healthcare

💊 Pharmaceuticals

Manufacturing • Healthcare • Pharmaceuticals

Arthrex is a global medical device company and leader in new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better®, Arthrex has pioneered the field of arthroscopy and developed more than 1,000 innovative products and surgical procedures each year to advance minimally invasive orthopedics worldwide. The company is committed to delivering uncompromising quality to healthcare professionals and the millions of patients whose lives they impact.

📋 Description

• 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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