Clinical Research Writer (Remote)

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.