Job Description

Responsibilities Provide medical review of clinical and certain regulatory documents (including Clinical Evaluation Plans and Clinical Evaluation Reports); Assess clinical safety and performance data to ensure anatomic, physiologic and clinical accuracy and use the available data to assess the benefits and risks of device use; Understand and provide guidance on comprehensive, systematic searches of published medical literature; Participate in the planning, development, and delivery of high-quality documents with a proactive approach to project management, including supervision of project timelines and communication of the process and timelines to stakeholders; Participate in stakeholder meetings with cross-functional teams; Resolve document content issues and questions that arise from the writing/review process; Provide status updates on deliverables to management; Understand medical writing and regulatory standards and practices; Proactively contribute to process improvements and knowledge sharing initiatives; Ensure consistency across and within documents; and Other duties as assigned (including the possibility of medical writing tasks). Qualifications MD or DO with medical device experience preferred; however, nurse practitioners and physician assistants may qualify, depending on training and experience; Some amount of direct patient care experience is needed so that the candidate can appropriately assess device risks and benefits; Candidate should be prepared to provide a list of procedures they have personally performed (e.g., tracheal intubation, central line placement, chest tube placement, etc.) Candidate should be prepared to describe clinical decision-making for which they were personally responsible (e.g., providing orders for patients on an inpatient floor, emergency department, outpatient clinic, etc.) Familiarity with literature search databases; Familiarity with statistical methods, data analysis, and interpretation; Ability to understand and interpret clinical/scientific data and to present results in an understandable and concise manner; Ability to work on multiple projects, organize, and prioritize within time constraints; Ability to work both independently and collaboratively in a cross-functional team environment; Familiarity with Microsoft Office software (including basic keyboarding skills); Excellent written, verbal, and interpersonal communication skills with attention to detail (to detect inconsistencies or errors in various types of documents and communications); and Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. #J-18808-Ljbffr Cook Research Inc

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