[Hiring] Clinical Research Writer @Arthrex

Role Description

Arthrex, Inc. 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
• Completing final study reports

The purpose of this job is to provide medical writing support for clinical study projects. 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.
• Ensure documents are produced per procedures, internal and external guidelines, and electronic templates.

Qualifications

• 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).
• Proficient in document development and management software skills: Word/Excel/PowerPoint.
• Demonstrated analytical and problem-solving skills.
• Ability to prioritize projects and activities while managing many projects in a time-constrained setting.
• Strong oral and written communication skills.
• Excellent skills in interpersonal communication, relationship building, and collaboration.
• Ability to translate scientific and statistical concepts into concise, accurate, and audience-appropriate content.
• Proficiency in reviewing and interpreting data tables, listings, figures, and statistical outputs.

Requirements

• 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 required.
• Strong knowledge of orthopedic medical and surgical terminology required.
• Previous experience writing study protocols, manuscripts for publication, interim study reports, and final study reports required.
• Medical writing or research certification required, or willing to obtain in 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)