Clinical Research Writer (US, Remote)

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical Research Medical Writer. This individual will provide overall management of the writing from the initial study concept through study completion, final/report, and publication. The position will mainly focus on developing clinical study protocols and associated documents, facilitating protocol amendments, drafting publications, reviewing publications, drafting interim study reports, and completing final study reports. The purpose of this job is to provide medical writing support for clinical study projects. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This position will be fully remote with periodic travel to the Naples, Florida headquarters as business needs require.

Essential Duties and Responsibilities:

• Perform comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support clinical study design.
• Combine an understanding of scientific and research methodology and medical device regulations and guidelines to support clinical research writing needs.
• Extract statistical data summaries, study conduct information, and study design information to prepare interim and final study reports.
• Prepare clinical study documents and coordinate with additional collaborators including product management, statistician, regulatory affairs, clinical research , and contract research organizations (CROs).
• Manage timelines required by product management and clinical research teams for writing deliverables and communicate progress to cross-functional teams.
• Review clinical and scientific deliverables for scientific accuracy, technical correctness, clarity, and conciseness, including PMCF protocols and reports, Arthrex- and investigator-initiated study protocols and reports, and manuscript drafts.
• Ensure documents are produced per procedures, internal and external guidelines, and electronic templates.

Knowledge and Skill Requirements/Specialized Courses and Training:

• Experience and degree in science, engineering, or medical fields. Scientific/research background (i.e., understands research design, methodology, and statistics).
• Working knowledge of EU MDR 2017/745, FDA 21 CFR 812, ISO:14155.
• Working knowledge of biomedical databases (i.e., PubMed, Embase).
• Must be proficient in document development and management software skills: Word/ Excel/ PowerPoint.
• Must have demonstrated analytical and problem-solving skills and have the ability to effectively and independently manage a large workload with minimal supervision.
• The ability to prioritize projects and activities while managing many projects in a time-constrained setting is required.
• Strong oral and written communication skills; ability to clearly present research information within and across functional areas.
• Excellent skills in interpersonal communication, relationship building, and collaboration.
• Ability to translate scientific and statistical concepts into concise, accurate, and audience-appropriate content for regulatory, clinical, scientific, and publication purposes.
• Proficiency in reviewing and interpreting data tables, listings, figures, and statistical outputs to ensure data are represented in clinical and scientific documents.

Education and Experience:

• Master’s required, PHD preferred.
• 4 years of relevant clinical research experience required.
• 2 years of experience in research/scientific writing in the medical device industry is required.
• Strong knowledge of orthopedic medical and surgical terminology is required.
• Previous experience writing study protocols, manuscripts for publication, interim study reports, and final study reports is required. Must have the ability to share examples of previous writing projects.
• Medical writing or research certification required, or willing to obtain in one year.

Arthrex 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)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Originally posted on Himalayas