Medical Reviewer

Medical Writer

Join our team as a Medical Writer, where you will play a crucial role in providing medical review of clinical and regulatory documents. This position offers an opportunity to contribute to high-quality documentation in a collaborative environment.

Job Description

• 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
• Other duties as assigned (including the possibility of medical writing tasks)

Requirements

• 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)
• 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

$145,000.00 / Annually - $170,000.00 / Annually