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Responsibilities
A Day in the LifeThe Surgical Operating Unit is a dynamic and impactful organization that brings together the people, technologies, and product portfolios of Core Surgical Innovation, Robotic Surgical Technologies, and Digital Technologies to advance surgical care and improve outcomes for patients around the world. We are seeking a Senior Medical Writer to join the Clinical Evaluation team in support of the Core Surgical Innovation business. Senior Medical Writer will be responsible for developing and maintaining key clinical evaluation documents, including Clinical Evaluation Reports, Summary of Safety and Clinical Performance reports, and Periodic Safety Update Reports, to support global regulatory and clinical documentation requirements. This remote position offers the opportunity to collaborate daily with cross-functional partners across multiple sites, contributing to the continued safety, performance, and advancement of our product portfolio for the benefit of the patients we serve.This role predominantly focuses on writing, editing and reviewing regulatory (e.g., Clinical Evaluation Reports, Summary of Safety and Clinical Performance, Periodic Safety Update Reports) documents and responses to Notified Bodies.Responsibilities may include the following and other duties may be assigned.Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.Reports instances of complaints/adverse events from literature to GCH.Create responses for audit/submission queries.Develop state of the art on product family for its intended purpose.Review/approve other documentation for device development (ie Labeling, Risk Management, etc).Collaborate with cross-functional team to assure high quality and successful project deliverySeek out and engage regularly with peers, creating an environment of exchange and learning. Openly share successes and failures to promote the group’s collective learning.Administration of the applicable databases for the activities related to the evaluation of clinical literature.Requires knowledge of product areas, current developments, and keeping abreast of current literature.Must Have: Minimum RequirementsBachelor’s degree requiredMinimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.Nice to HaveMasters or PhD degree(s) in biomedical sciences or technical disciplines; PharmDExperience with medical and/or scientific writing within a medical device industry or related industry including preparation of Clinical Evaluation Reports and post market surveillance reporting.Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable
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