Medical Writer

hace 2 semanas

Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo
{"Job Summary": "As a Zimmer Biomet Medical Writer, you will be responsible for preparing Clinical Evaluation Reports (CERs) and Post-market Surveillance Plan literature reviews for regulatory submissions and analysis of existing product clinical performance. This involves conducting searches of peer-reviewed publications, national implant registries, risk management files, and post-market quality tabulations to compile relevant data. You will summarize data found and draft risk versus benefit analyses for review by Senior Medical Writer or designee.", "About the Role": "The Medical Writer is primarily responsible for preparing clinical documents according to applicable regulations (including MDR (EU) 2017/745) and Zimmer Biomet internal procedures using relevant information compiled from clinical research, peer-reviewed publications, risk management files, and post-market data.", "Responsibilities": "* Identify pertinent internal and external sources of clinical data and conduct systematic literature searches of peer-review publications.* Prepare Clinical Evaluation documents according to applicable regulations and Zimmer Biomet internal procedures using relevant information compiled from clinical research, peer-reviewed publications, risk management files, and post-market data.* Summarize findings and draft risk versus benefit analyses and conclusions, for review by Medical Writing Manager or designee, based on clinical and post-market data.* Distribute reviewed final draft reports to Clinical Affairs, Regulatory Affairs, Post-Market Surveillance, and Development Engineering groups to verify and approve content of final draft document.* Prepare reviews of peer-reviewed literature for inclusion in Zimmer Biomet post-market surveillance (PMS) reports.* Support the Manager or Team Leader for Audit activities including participation in Audits as clinical evidence SME as needed.* File work in the Clinical Evaluation archives, provide clinical data searches and documentation as a service to various functions within Zimmer Biomet, and provide verbal and/or written progress reports monthly.", "Requirements": "* Proficient in English – written and spoken.* Excellent written and verbal communications skills.* Demonstrated technical and medical writing competence.* Strong organizational skills, attention to detail, and proofreading skills.* Understanding of statistical methods.* Ability to critically analyze and interpret scientific data.* Have an analytic and strategic mindset.* Ability to work within tight deadlines, adjust to changes in priorities.* Ability to function independently.* Ability to identify problems and research possible solutions.* Takes actions that are best for the company versus his or her individual unit.* Encourages and supports information sharing and collaboration across teams and departments.* Demonstrates sound business ethics; shows consistency among principles, values, and behaviors.* Strong ability to interpret and disseminate relevant clinical studies / medical product information.* Proficiency in MS Office applications and proficiency in or ability to learn EndNote or Reference Manager or other similar software tools needed for performing the job.* Basic understanding of regulatory compliance for medical devices.", "Education": "* Minimum of a Bachelor’s degree or equivalent education in health, life sciences, engineering, or a similar discipline required. MD, MS, and PhD preferred.* Demonstrated authorship of scientific publications in peer-review journals will be an asset.* 3-5 years of experience in medical writing, clinical affairs, regulatory affairs, or product engineering in the medical device industry required, with a strong preference to those with similar work experience in the orthopedic medical device industry.* In lieu of the medical device industry experience, 3-5 years as a professor or senior investigator in a healthcare-related field, with a demonstrated record of research and scientific publications.", "Travel Expectations": "Up to 5%"}

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