Clinical Research Writer

This is a fully remote position, open to applicants in Florida.

📋 Description

• Oversee the clinical research writing process from the initial study concept to study completion, final reporting, and publication.

• Conduct thorough literature reviews to support the design of clinical studies.

• Implement scientific and research methodologies along with medical device regulations and guidelines in clinical research writing.

• Summarize statistical data, study conduct details, and study design information for both interim and final reports.

• Create clinical study documentation.

• Collaborate with product management, statisticians, regulatory affairs, clinical research teams, and contract research organizations.

• Manage timelines for writing deliverables and update cross-functional teams on progress.

• Evaluate clinical and scientific deliverables for accuracy, technical precision, clarity, and conciseness.

• Develop and assess PMCF protocols and reports, as well as Arthrex- and investigator-initiated study protocols and manuscripts.

• Ensure adherence to procedures, internal and external guidelines, and electronic templates.

⛳️ Requirements

• A degree and experience in science, engineering, or the medical field.

• A scientific/research background with knowledge of research design, methodology, and statistics.

• Familiarity with EU MDR 2017/745, FDA 21 CFR 812, and ISO:14155.

• Proficient in biomedical databases, including PubMed and Embase.

• Skilled in Word, Excel, and PowerPoint.

• Proven analytical and problem-solving abilities.

• Capable of independently managing a substantial workload with minimal oversight.

• Able to prioritize projects and tasks effectively in a time-sensitive environment.

• Strong verbal and written communication skills.

• Excellent interpersonal communication, relationship-building, and collaboration abilities.

• Competent in translating scientific and statistical concepts into clear, precise content suitable for the audience.

• Proficient in reviewing and interpreting data tables, listings, figures, and statistical outputs.

• A Master’s degree is required; a PhD is preferred.

• Minimum of 4 years of relevant clinical research experience is required.

• At least 2 years of research/scientific writing experience in the medical device sector is required.

• Strong understanding of orthopedic medical and surgical terminology is required.

• Previous experience in writing study protocols, publication manuscripts, interim reports, and final reports is required.

• Ability to provide examples of past writing projects.

• Medical writing or research certification is required, or the 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.

• Occasional travel to the Naples, Florida headquarters as needed for business purposes.