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.
  

Compensation Information:
$145000.00 / Annually - $170000.00 / Annually

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