Career Opportunities: Clinical Research Writer (remote) (59683)

**This position is based in Naples, FL. Open to remote for the right candidate. If remote, travel to HQ for one week every quarter is required**

Arthrex is a global medical device company and leader in research, 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 develops more than 1,000 innovative products and procedures each year that support all aspects of orthopedics. The Orthopedic Research department based in Naples; includes a team of clinical, biomaterials and biomechanical professionals. Arthrex is actively searching for a Clinical Research Writer to join the Orthopedic Research department. The successful candidate will work alongside the team organizing and overseeing research studies to contribute to advances in the medical community. Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and a bachelor’s degree in a related field are required for success in this position. Clinical Research Professional certification is also strongly encouraged. Come join our growing talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

The position provides overall management of the technical 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 technical and medical writing support for clinical study projects.

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 technical writing needs.
• Extracts statistical data summaries, study conduct information, and study design information to prepare interim and final study reports
• Prepares clinical study documents and coordinates with additional collaborators including product management, statistician, regulatory affairs, clinical research management, and contract research organizations (CROs)
• Manage timelines required by product development and clinical research teams for technical writing deliverables and communicates progress to cross-functional teams
• Ensure documents are produced per procedures, internal and external guidelines, and electronic templates

Education and Experience:

• Master’s required, PHD preferred
• 4 years of relevant clinical research experience required
• 2 years of experience in technical/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
• Relevant Certification required, or willing to obtain in one year
• Experience reviewing or drafting documents for EU MDR (i.e. CER, CEP, PMCFP) preferred

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 technical information within and across functional areas
• Excellent skills in interpersonal communication, relationship building, and collaboration

Machine, Tools, and Equipment Skills:

Literature search tools, online meeting programs, citation manager software (EndNote)

Arthrex 2024 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 or protected veteran status.